Taking VIAGRA® (sildenafil citrate) | Safety Info

Do not take VIAGRA if you:

• take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level
• are allergic to sildenafil, as contained in VIAGRA and REVATIO, or any of the ingredients in VIAGRA

Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sex, seek immediate medical help.

VIAGRA can cause serious side effects. Rarely reported side effects include:

• an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis
• sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking VIAGRA and call your healthcare provider right away if you have any sudden vision loss
• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking VIAGRA and contact a doctor right away

Before you take VIAGRA, tell your healthcare provider if you:

• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure
• have had heart surgery within the last 6 months
• have pulmonary hypertension
• have had a stroke
• have low blood pressure, or high blood pressure that is not controlled
• have a deformed penis shape
• have had an erection that lasted for more than 4 hours
• have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia
• have retinitis pigmentosa, a rare genetic (runs in families) eye disease
• have ever had severe vision loss, including an eye problem called NAION
• have bleeding problems
• have or have had stomach ulcers
• have liver problems
• have kidney problems or are having kidney dialysis
• have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

VIAGRA may affect the way other medicines work, and other medicines may affect the way VIAGRA works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• medicines called nitrates
• medicines called guanylate cyclase stimulators such as Adempas (riociguat)
• medicines called alpha-blockers, such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of VIAGRA with alpha-blockers can lead to a drop in blood pressure or to fainting
• medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase), or atazanavir sulfate (Reyataz)
• some types of oral antifungal medicines, such as ketoconazole (Nizoral) and itraconazole (Sporanox)
• some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin
• other medicines that treat high blood pressure
• other medicines or treatments for ED
• VIAGRA contains sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). VIAGRA should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil])

VIAGRA does not protect against sexually transmitted diseases, including HIV.

The most common side effects of VIAGRA: headache; flushing; upset stomach; abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision; stuffy or runny nose; back pain; muscle pain; nausea; dizziness; rash.

INDICATION

VIAGRA (sildenafil citrate) is prescription medicine used to treat erectile dysfunction (ED).

VIAGRA is not for women or children.

Please see Full Prescribing Information and Patient Information.

Impotence (Erectile Dysfunction) Medical Health Quiz on RxList.com

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Sources:

NIDDK. Erectile Dysfunction. National Kidney and Urologic Diseases Information Clearinghouse.
<http://kidney.niddk.nih.gov/kudiseases/pubs/ed/erectiledysfunction_508.pdf>

Urology Care Foundation. ED: Non-surgical Management (Erectile Dysfunction).
<http://www.urologyhealth.org/urology/index.cfm?article=60>

National Kidney Foundation. Impotence.
<http://www.kidney.org/atoz/content/impotence>

Johns Hopkins Medicine. Prostate Cancer. Erectile Dysfunction Following Radical Prostatectomy.
<http://urology.jhu.edu/prostate/erectyle_dyssfunction.php>

Urology Care Foundation, Inc. Low Testosterone (Hypogonadism).
<http://www.urologyhealth.org/urology/index.cfm?article=132>

Harvard University. Harvard Health Blog. Erectile dysfunction often a warning sign of heart disease.
<http://www.health.harvard.edu/blog/erectile-dysfunction-often-a-warning-sign-of-heart-disease-201110243648>

Sexual Medicine Society of North America, Inc. Vascular Surgery – Erectile Dysfunction.
<http://www.sexhealthmatters.org/erectile-dysfunction/vascular-surgery-erectile-dysfunction>

Caverject^® is a registered trademarks of Pfizer.

Cialis^® is a registered trademark of Lilly.

Edex^® is a registered trademark of Auxilium Pharmaceuticals, Inc.

Levitra^® is a registered trademark of Bayer.

Muse^® is a registered trademark of Meda Pharmaceuticals Inc.

Viagra^® is a registered trademark of Pfizer.

THIS TOOL DOES NOT PROVIDE MEDICAL ADVICE. It is intended for general informational purposes only and does not address individual circumstances. It is not a substitute for professional medical advice, diagnosis or treatment and should not be relied on to make decisions about your health. Never ignore professional medical advice in seeking treatment because of something you have read on the RxList Site. If you think you may have a medical emergency, immediately call your doctor or dial 911.

Sildenafil (Oral Route) Proper Use

Proper Use

Drug information provided by: IBM Micromedex

Use sildenafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects is increased.

Special patient instructions comes with sildenafil. Read the directions carefully before you start using sildenafil and each time you get a refill of your medicine.

You may take this medicine with or without food.

If you are using the oral liquid, shake the bottle well for at least 10 seconds before measuring each dose. Use the oral syringe provided in the package to measure each dose. Wash the oral syringe after each use.

This medicine usually begins to work for erectile dysfunction within 30 minutes after taking it. It continues to work for up to 4 hours, although its action is usually less after 2 hours.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 
  For treatment of erectile dysfunction:
  • 
    For oral dosage form (tablets):
    • 
      Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Alternatively, the medicine may be taken 30 minutes to 4 hours before sexual intercourse. Your doctor may adjust your dose if needed.
    • 
      Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. Alternatively, the medicine may be taken 30 minutes to 4 hours before sexual intercourse. Your doctor may adjust your dose if needed.
    • 
      Children—Use is not recommended.

• 
  For treatment of pulmonary arterial hypertension:
  • 
    For oral dosage forms (suspension or tablets):
    • 
      Adults—5 or 20 milligrams (mg) three times a day. Each dose should be taken about 4 to 6 hours apart.
    • 
      Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused mixed Revatio® oral liquid after 60 days.

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.

High dose sildenafil citrate as a salvage therapy for severe erectile dysfunction

The recognition that blood flow into the corpora cavernosa is regulated by vascular smooth muscle tone and that this tone can be pharmacologically altered with a variety of agents is regarded as one of the most significant advances in the treatment of ED. Initial therapy for ED should ideally be determined by etiology but also evidence based, depending on factors such as treatment efficacy, adverse effects, patient and partner acceptance, psychological effect, reversibility and cost. The ideal treatment for ED must be simple to take, non-invasive, non-painful, have a high success rate and cause few minor side effects.¹² Of the treatment options currently available, sildenafil most closely fulfils these criteria. The majority of ED sufferers currently choose oral therapy as a first line treatment and are prescribed sildenafil, the only PDE5 inhibitor currently available.

Response to sildenafil is reduced in chronic ED caused by either severe vasculogenic ED or post radical prostatectomy ED. Steers et al reported that only 55 and 59% of patients with severe ED achieved a response score of 4 or 5 to questions 3 and 4, respectively, of the IIEF inventory erectile function domain when treated with sildenafil 100 mg. Improved erections were reported by only 57% of patients with diabetes mellitus treated with sildenafil in a 3 month flexible dose study.¹³ McMahon et al have reported that sildenafil is less effective in patients with CVOD as opposed to patients with arteriogenic ED. They demonstrated an inverse relationship between the severity of CVOD as determined by the DICC parameter, flow-to-maintain (FTM), and the response to sildenafil, as judged by patient scores to IIEF erectile function domain questions 3 and 4. They concluded that only patients with mild CVOD and a FTM ≤30 ml/min are likely to respond to sildenafil or combined sildenafil/ICI.¹⁴ This is contrary to that reported by Shabsigh who suggested that sildenafil is effective in improving erectile function in patients with ED regardless of the etiology in a randomised placebo controlled study of 329 consecutive patients.¹⁵ Shabsigh reported that although responses to questions 3 or 4 of the IIEF in patients treated with sildenafil were superior to placebo, responses did not differ in patients with organic, psychogenic or mixed ED.

The majority of the 30–35% of ED sufferers who fail to respond to the maximum recommended dose of sildenafil (100 mg), chose ICI therapy as second line therapy. Shabsigh et al reported that alprostadil therapy can be used effectively and safely in patients who fail initial therapy with sildenafil. In 67 patients who did not respond satisfactorily to sildenafil, alprostadil ICI resulted in significant improvement in questions 3 and 4 of the IIEF inventory erectile function domain in 60 (89.6%) and 57 (85.1%) patients, respectively.¹⁶ Combined sildenafil and ICI therapy has been previously reported as effective salvage therapy for sildenafil non-responders. Twenty nine of 61 patients (47.5%) who failed to respond to sildenafil monotherapy, responded to combined therapy with sildenafil (100 mg) and Trimix ICI with an erection suitable for sexual intercourse.¹⁴ Clearly ICI, despite lacking the obvious appeal of an oral medication, remains one of the major elements in the ED treatment armamentarium.

This study group comprised an unselected heterogenous population of chronic ED sufferers and included patients with psychogenic ED and organic ED of a predominantly vasculogenic aetiology. This study demonstrates that administration of sildenafil at doses of 150–200 mg results in sufficient rigidity to achieve vaginal intromission and complete satisfactory sexual intercourse in 24.1% of ED sufferers who had previously failed a trial of sildenafil 100 mg. This is contrary to the manufacturer sponsored pre-marketing studies, where the erectile response to a dose of 200 mg was not differentiable from 100 mg.¹⁷ In this study, the response to sildenafil was independent of patient age and duration of ED but was highly dependent on etiology of ED. Rigidity sufficient for satisfactory sexual intercourse was reported by 80% of patients with psychogenic ED but only 18.4% of patients with organic ED. As has been reported previously, patients with CVOD appear less likely to respond to sildenafil as is the case with ICI treatment. Patients with CVOD, either as pure CVOD or as MVED, had significantly lower responses to sildenafil 200 mg than patients with arteriogenic ED (P<0.05). Clearly, our concepts about the etiology and mechanism of CVOD may need revision. CVOD is probably a multi-etiological condition involving not only degenerative cavernous myopathy, incompetence of the tunica albuginea or corporo-spongiosal shunts but also possibly disturbances of penile innervation or neurotransmitter release, failure in prostanoid synthesis or signal transduction via gap junctions, malfunctions of the enzymes nitric oxide synthase, adenylcyclase or guanylate cyclase or malfunction of the potassium channels. If this is in fact correct, it seems reasonable to assume that different etiologies of CVOD may respond to different treatments, that combination treatments may have a role and that our future management of patients with ED may re-focus on an evidence based etiological diagnosis approach in order to identify the most rational etiology specific treatment(s).

A failure to respond to sildenafil was common in patients with post RRP ED for prostate cancer. This parallels the experience of the Sildenafil Study Group who reported that only 43% of patients who had had RRP responded to sildenafil and suggested surgical damage to the cavernous nerves, with subsequent failure to activate the NO-cGMP pathway as the probable mechanism.⁶ Our study group was unselected, relatively small and comprised a majority of patients who had undergone non-nerve sparing procedures. Improved results would be expected following a nerve sparing procedure. Lowentritt et al reported improved erections in 53% and improved capacity for sexual intercourse in 40% of patients taking sildenafil after nerve sparing RRP which was dependent on patient age, pathological stage and degree of nerve sparing surgical technique.¹⁸ Hong et al suggested that the response to sildenafil was dependent upon the interval between nerve sparing RRP and reported that the treatment satisfaction increased to a peak at 60% 18–24 months after surgery.¹⁹

Adverse effects were reported more frequently by participants in this study than by participants in the earlier studies although the adverse effect severity profile was similar.^6,8,9,20 Headaches, facial flushing, nasal congestion and dyspepsia remained the most common adverse effects. The higher incidence of reported adverse effects in this study clearly relates to the higher dose of sildenafil used. Adverse effects reflect the pharmacological action of sildenafil as a PDE-5 inhibitor and a weak PDE-6 inhibitor. Of particular interest is the fact that 31% of sildenafil responders were not prepared to continue treatment with sildenafil due to intolerable adverse effects. This contrasts significantly to that reported previously (2.6% and 9%).^6,11 This is, however, less than the reported alprostadil ICI drop-out rate of 37%.²¹ As such, the role of high dose salvage therapy is limited by patient acceptance of a higher incidence of adverse effects.

This study reports a lack of major cardiovascular adverse effects associated with taking high dose sildenafil confirming the previously reported excellent safety profile of sildenafil. An increased risk of developing coronary artery disease and myocardial infarction in patients suffering ED is also demonstrated. An association between atherosclerotic coronary artery disease (CAD) and ED has been reported by several investigators. This is not surprising as the majority of patients with ED have vasculogenic ED due to atherosclerosis of the hypogastrico-cavernous axis. Furthermore, both clinical entities share the same risk factors including cigarette smoking, hypertension, hyperlipidaemia and diabetes mellitus. The incidence of acute myocardial infarction and cardiac death in this study exceeds that reported in the general community.²²

Several authors have suggested an increased incidence of silent myocardial ischaemia in patients with vasculogenic ED over the general community and identified vasculogenic ED as a possible independent risk factor for coronary artery disease.^23,24,25,26 Matsuzawa et al reported that 5 out of 20 patients with ED and no prior history of coronary artery disease, had exercise electrocardiogram changes suggestive of silent coronary artery disease.²⁴ Similarly, Kawanishi et al reported a 20.7% incidence of abnormal stress electrocardiograms in 58 patients with ED and no history of coronary artery disease. They reported abnormal stress electrocardiogram findings in 54.8% of patients with penile CDU evidence of vasculogenic ED as opposed to only 3.7% of patients with normal penile CDU.²⁵ Unfortunately the results of coronary angiography were not reported in either study so the high incidence of abnormal stress electrocardiogram findings reported almost certainly overstates the true incidence of silent myocardial ischaemia. Physicians must consider the cardiovascular status of ‘at risk’ patients with vasculogenic ED and significant vascular risk factors prior to initiating any treatment for ED including sildenafil. Sildenafil prescribing guidelines proposed by the ACC/AHA should be followed and ‘at risk’ patients may require cardiological assessment with exercise electrocardiography, stress echocardiography or persantin thallium stress testing.²⁷

Viagra 25mg, 50mg, 100mg – Summary of Product Characteristics (SmPC)

This information is intended for use by health professionals

VIAGRA 25 mg film-coated tablets

VIAGRA 50 mg film-coated tablets

VIAGRA 100 mg film-coated tablets

Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil.

Excipient with known effect:

VIAGRA 25 mg film-coated tablets

Each tablet contains 0.9 mg lactose (as monohydrate).

VIAGRA 50 mg film-coated tablets

Each tablet contains 1.7 mg lactose (as monohydrate).

VIAGRA 100 mg film-coated tablets

Each tablet contains 3.5 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Film-coated tablet.

VIAGRA 25 mg film-coated tablets

Blue rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 25” on the other.

VIAGRA 50 mg film-coated tablets

Blue rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 50” on the other.

VIAGRA 100 mg film-coated tablets

Blue rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 100” on the other.

VIAGRA is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

In order for VIAGRA to be effective, sexual stimulation is required.

Posology

Use in adults

The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If VIAGRA is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).

Special populations

Elderly

Dosage adjustments are not required in elderly patients (≥ 65 years old).

Renal impairment

The dosing recommendations described in “Use in adults” apply to patients with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min).

Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.

Hepatic impairment

Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.

Paediatric population

VIAGRA is not indicated for individuals below 18 years of age.

Use in patients taking other medicinal products

With the exception of ritonavir for which co-administration with sildenafil is not advised (see Section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).

In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at a dose of 25 mg should be considered (see sections 4.4 and 4.5).

Method of administration

For oral use.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.

The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).

Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure).

VIAGRA is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).

The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure < 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.

Cardiovascular risk factors

Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1). Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.

VIAGRA potentiates the hypotensive effect of nitrates (see section 4.3).

Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of VIAGRA. Most, but not all, of these patients had pre-existing cardiovascular risk factors. Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of VIAGRA without sexual activity. It is not possible to determine whether these events are related directly to these factors or to other factors.

Priapism

Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).

Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. In the event of an erection that persists for longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction

The safety and efficacy of combinations of sildenafil with other PDE5 inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing sildenafil (REVATIO), or other treatments for erectile dysfunction have not been studied. Therefore the use of such combinations is not recommended.

Effects on vision

Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8). Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8). Patients should be advised that in the event of any sudden visual defect, they should stop taking VIAGRA and consult a physician immediately (see section 4.3).

Concomitant use with ritonavir

Co-administration of sildenafil with ritonavir is not advised (see section 4.5).

Concomitant use with alpha-blockers

Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the co-administration may lead to symptomatic hypotension in a few susceptible individuals (see section 4.5). This is most likely to occur within 4 hours post sildenafil dosing. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Initiation of sildenafil at a dose of 25 mg should be considered (see section 4.2). In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms.

Effect on bleeding

Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.

Excipients

The film coating of the tablet contains lactose. VIAGRA should not be administered to men with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet. Patients on low sodium diets can be informed that this medicinal product is essentially ‘sodium-free’.

Women

VIAGRA is not indicated for use by women.

Effects of other medicinal products on sildenafil

In vitro studies

Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.

In vivo studies

Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine). Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25 mg should be considered.

Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil C_max and a 1,000% (11-fold) increase in sildenafil plasma AUC. At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when sildenafil was administered alone. This is consistent with ritonavir’s marked effects on a broad range of P450 substrates. Sildenafil had no effect on ritonavir pharmacokinetics. Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised (see section 4.4) and in any event the maximum dose of sildenafil should under no circumstances exceed 25 mg within 48 hours.

Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil C_max and a 210% increase in sildenafil AUC. Sildenafil had no effect on saquinavir pharmacokinetics (see section 4.2). Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects.

When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC). In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, C_max, t_max, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.

Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil.

Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil.

Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates). In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, (an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at steady state (125 mg twice a day) with sildenafil at steady state (80 mg three times a day) resulted in 62.6% and 55.4% decrease in sildenafil AUC and C_max, respectively. Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil.

Nicorandil is a hybrid of potassium channel activator and nitrate. Due to the nitrate component it has the potential to result in a serious interaction with sildenafil.

Effects of sildenafil on other medicinal products

In vitro studies

Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC₅₀ >150 μM). Given sildenafil peak plasma concentrations of approximately 1 μM after recommended doses, it is unlikely that VIAGRA will alter the clearance of substrates of these isoenzymes.

There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.

In vivo studies

Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).

Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated (see section 4.3).

Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals. This is most likely to occur within 4 hours post sildenafil dosing (see sections 4.2 and 4.4). In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. In these study populations, mean additional reductions of supine blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were observed. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. These reports included dizziness and light-headedness, but not syncope.

No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.

Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).

Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.

Pooling of the following classes of antihypertensive medication; diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment. In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).

Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.

In healthy male volunteers, sildenafil at steady state (80 mg t.i.d.) resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan C_max (125 mg b.i.d.).

VIAGRA is not indicated for use by women.

There are no adequate and well-controlled studies in pregnant or breast-feeding women.

No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.

There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 5.1).

Viagra may have a minor influence on the ability to drive and use machines.

As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to VIAGRA, before driving or operating machinery.

Summary of the safety profile

The safety profile of VIAGRA is based on 9,570 patients in 74 double blind placebo-controlled clinical studies. The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and blurred vision.

Adverse reactions from post-marketing surveillance has been gathered covering an estimated period >10 years. Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.

Tabulated list of adverse reactions

In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to, 1/1,000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1: Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance

*Reported during post-marketing surveillance only

**Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia

***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.

Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction. ATC Code: G04B E03.

Mechanism of action

Sildenafil is an oral therapy for erectile dysfunction. In the natural setting, i.e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.

The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.

Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP. Sildenafil has a peripheral site of action on erections. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue. When the NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects.

Pharmacodynamic effects

Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Its effect is more potent on PDE5 than on other known phosphodiesterases. There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE 2, 3, 4, 7, 8, 9, 10 and 11. In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.

Clinical efficacy and safety

Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.

Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects. The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg. The corresponding change in supine diastolic blood pressure was 5.5 mmHg. These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle. Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.

In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (>70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline. Mean pulmonary systolic blood pressure decreased by 9%. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries.

A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates). The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina.

Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose. The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. Sildenafil has no effect on visual acuity or contrast sensitivity. In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).

There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).

Further information on clinical trials

In clinical trials sildenafil was administered to more than 8000 patients aged 19-87. The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%). The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).

In fixed dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on placebo. In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.

Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%). The safety and efficacy of sildenafil was maintained in long term studies.

Paediatric population

The European Medicines Agency has waived the obligation to submit the results of studies with VIAGRA in all subsets of the paediatric population for the treatment of erectile dysfunction. See section 4.2 for information on paediatric use.

Absorption

Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The mean absolute oral bioavailability is 41% (range 25-63%). After oral dosing of sildenafil AUC and C_max increase in proportion with dose over the recommended dose range (25-100 mg).

When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in t_max of 60 minutes and a mean reduction in C_max of 29%.

Distribution

The mean steady state volume of distribution (V_d) for sildenafil is 105 l, indicating distribution into the tissues. After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/mL (CV 40%). Since sildenafil (and its major circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/mL (38 nM). Protein binding is independent of total drug concentrations.

In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.

Biotransformation

Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-demethylation of sildenafil. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug. Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil. The N-desmethyl metabolite is further metabolised, with a terminal half life of approximately 4 h.

Elimination

The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).

Pharmacokinetics in special patient groups

Elderly

Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years). Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40%.

Renal insufficiency

In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose. The mean AUC and C_max of the N-desmethyl metabolite increased up to 126% and up to 73% respectively, compared to age-matched volunteers with no renal impairment. However, due to high inter-subject variability, these differences were not statistically significant. In volunteers with severe renal impairment (creatinine clearance < 30 mL/min), sildenafil clearance was reduced, resulting in mean increases in AUC and C_max of 100% and 88% respectively compared to age-matched volunteers with no renal impairment. In addition, N-desmethyl metabolite AUC and C_max values were significantly increased by 200% and 79% respectively.

Hepatic insufficiency

In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance was reduced, resulting in increases in AUC (84%) and C_max (47%) compared to age-matched volunteers with no hepatic impairment. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied.

Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.

Tablet core:

microcrystalline cellulose

calcium hydrogen phosphate (anhydrous)

croscarmellose sodium

magnesium stearate

Film coat:

hypromellose

titanium dioxide (E171)

lactose monohydrate

triacetin

indigo carmine aluminium lake (E132)

Do not store above 30°C.

Store in the original package in order to protect from moisture.

VIAGRA 25 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.

VIAGRA 50 mg film-coated tablets

PVC/Aluminium blisters in cartons or secondary heat sealed card packaging of 2, 4, 8, 12 or 24 tablets.

VIAGRA 100 mg film-coated tablets

PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets

Not all pack sizes may be marketed.

Upjohn EESV

Rivium Westlaan 142

2909 LD Capelle aan den IJssel

Netherlands

VIAGRA 25 mg film-coated tablets

EU/1/98/077/002-004

EU/1/98/077/013

VIAGRA 50 mg film-coated tablets

EU/1/98/077/006-008

EU/1/98/077/014

EU/1/98/077/016-019

EU/1/98/077/024

VIAGRA 100 mg film-coated tablets

EU/1/98/077/010-012

EU/1/98/077/015

EU/1/98/077/025

Date of first authorisation: 14 September 1998

Date of latest renewal: 14 September 2008

11/2020

LEGAL CATEGORY

POM

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.eu/ema/

Ref VI 38_1

How Much Sildenafil is Too Much? Maximum Dosage and Safety

Men who are suffering from erectile dysfunction have more options than ever before to treat the condition. While Viagra was the first approved prescription medication for the treatment of erectile dysfunction in 1998, the medication’s demand, popularity, and novelty made the price out of reach for many, partially contributing to the development of other prescription drugs for sexual stimulation such as tadalafil (Cialis) and vardenafil (Levitra). 

Since 2017, sildenafil citrate, the generic form of Viagra, has been available for the treatment of erectile dysfunction. If you’re considering treatment with sildenafil, you might be wondering how much sildenafil is too much and what the maximum dosage and safety concerns might be.

What is sildenafil?

Sildenafil is the generic form of Viagra which is the brand name manufactured by Pfizer. Sildenafil is sold under two brand names (Viagra and Revatio, which is used for the treatment of high blood pressure and pulmonary arterial hypertension). The drug was first approved by the U.S. Food and Drug Administration (FDA) in December 2017 after the original manufacturer’s patent ran out, though this drug is still not (and likely will not become) available over-the-counter since certain contraindications need to be screened for by a healthcare provider for patient safety.

What is erectile dysfunction and what causes it?

Erectile dysfunction, also known as male impotence, is a health condition in which men are unable to get and/or keep an erection that is hard enough for sexual activity. It happens when not enough blood flows to the penis, preventing an erection.  Erectile dysfunction is extremely common, affecting approximately 30 million men in the U.S. While some people with the condition only experience erectile dysfunction occasionally, others deal with the issue every time they try to have sex. 

There are a variety of reasons why men experience erectile dysfunction, including medical conditions, lifestyle factors, and psychological issues. Some of the most common medical conditions known to contribute to erectile dysfunction include depression, diabetes, heart disease, high blood pressure, high cholesterol, obesity, prostate cancer treatment, and spinal cord injury. 

Lifestyle and psychological factors, such as smoking, drinking, and stress, can also contribute to erectile dysfunction. The use of certain medications, including those used to treat high blood pressure, heart disease, and depression, can also cause erectile dysfunction.

Erectile dysfunction can often be improved or prevented by making lifestyle changes. Patients who are hoping to improve their circulation without medication can try the following:

• Finding more ways to stay active
• Quitting smoking
• Reducing stress in your daily life
• Managing your weight by eating whole foods and reducing portion sizes
• Drinking less alcohol

How does sildenafil treat erectile dysfunction?

In the most general terms, sildenafil works by increasing blood flow to the penis by allowing the muscles of the penis to stay relaxed for longer, helping to trap blood in the blood vessels and maintain an erection that is hard enough for sexual intercourse. 

Sildenafil can also help with painful erections, especially those caused by Peyronie’s disease. 

How much sildenafil is too much?

Patients are prescribed sildenafil at varying dosages depending on the severity of their condition, age, medical history, and weight. Sildenafil tablets typically come in 20 mg dosages, and patients requiring a higher dose of the medication simply take multiple tablets. The lowest prescribed dose of sildenafil is 20 mg, while the highest recommended dose of sildenafil is 100 mg.  As noted previously, sildenafil is also used to treat high blood pressure and pulmonary atrial hypertension, and was originally developed for the treatment of angina as a phosphodiesterase type 5 inhibitor (PDE5 inhibitor). 

These conditions are generally treated with a 20 mg dose of sildenafil, while erectile dysfunction is treated with dosages ranging from 20 to 100 mg. The average starting dose of sildenafil is 50 mg for most men.  Your doctor may start you at a dose higher or lower than this initially based on your needs. However, it should be noted that taking more sildenafil won’t necessarily make your erection any harder or make it last any longer. 

Men are recommended to take the minimum dose that meets their needs. While the maximum dose of sildenafil is 100 mg, many men find that a lower dose provides the treatment they need. Taking a higher dose of sildenafil will increase your risk of experiencing side effects, including side effects that are potentially dangerous. Patients should never take more than 100 mg of sildenafil within 24 hours. 

Viagra and Sildenafil | Rex MD ED Treatment

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Are there any side effects associated with sildenafil?

Like any medication, there are side effects associated with the use of sildenafil. Side effects are more likely to occur in people who have difficulty processing sildenafil and in people who take sildenafil at higher doses. The side effects most commonly associated with sildenafil are:

• Headache
• Heartburn
• Difficulty falling asleep or staying asleep
• Numbness, burning, or tingling in the arms, hands, feet, or legs
• Diarrhea
• Facial flushing (feeling of warmth)
• Nosebleeds
• Nasal congestion
• Muscle aches
• Sensitivity to light

Other rarely reported, but serious, side effects requiring you seek immediate medical advice include:

• Priapism – erections lasting longer than four hours
• Sudden vision loss in one or both eyes, which is a symptom of a serious eye problem called non-arteric anterior ischemic optic neuropathy (NAION)
• Chest pain (angina)
• Worsening shortness of breath
• Itching or burning during urination
• Sudden hearing decrease, hearing loss, or ringing in the ears
• Prolonged blurred vision
• Dizziness or lightheadedness
• Fainting
• Heart attack
• Stroke
• Irregular heartbeat
• Rash
• Bleeding in the brain or lungs
• High blood pressure
• Death 

Are there any safety concerns associated with sildenafil?

Sildenafil is generally considered safe in people who have an appropriate medical history and receive their doctor’s approval for the drug. However, some people should not take sildenafil at all and others will be prone to a higher risk of dangerous side effects. 

Sildenafil interacts dangerously with certain medications, including poppers inhalant nitrates like nitroglycerin, isosorbide nitrate, and amyl nitrate, which are often prescribed for chest pain, and guanylate cyclase stimulators such as Adempas (riociguat) for pulmonary hypertension. Individuals taking these medications could experience an unsafe drop in blood pressure if taking sildenafil, so sildenafil use is not recommended for these groups. Additionally, people who are allergic to sildenafil or any of its ingredients should not take the medication. 

People with a previous history of heart problems are more likely to experience dangerous side effects when taking sildenafil. Rare side effects such as heart attack, stroke, irregular heartbeat, and death have occurred in some men while using the medication. Although these side effects are more common in patients who had a previous history of heart problems prior to taking the drug, patients with no history of heart problems have also experienced these side effects. 

More research is needed in order to determine whether sildenafil causes or contributes to the possibility of experiencing heart attack, stroke, irregular heartbeat, and death. Regardless, men with a history of heart problems or those with a high risk of experiencing heart issues should talk to their doctors about their medical history prior to taking sildenafil.

Is there a difference between Viagra and sildenafil?

Although sildenafil is associated with numerous side effects and warnings for use, there are many benefits to using the drug, and sildenafil is one of the most popular medications in the world for a reason. Sildenafil provides relief from a number of medical conditions, including high blood pressure, pulmonary hypertension, Raynaud’s Phenomenon, and erectile dysfunction. 

Sildenafil is equally effective compared to Viagra, but it is available at a fraction of the cost. Some patients are wary about using generic drugs due to quality concerns and a lack of understanding about the effectiveness of the ingredients found in generic drugs. After all, there is a huge difference in the price of Viagra compared to sildenafil. How is that possible? 

Generic medications like sildenafil undergo the same rigorous quality testing and standards that brand name medications like Viagra do, and they are approved by the U.S. Food and Drug Administration. Generic drugs use the same active ingredients in the same quantities as the brand name medication and must be shown to be equally effective. 

The only real differences between the generic and brand name drugs are some of the inactive ingredients (ingredients that do not affect treatment) and cosmetic details like color, shape, and size of the medication. 

Generic drugs are less expensive because they can be produced by a number of different manufacturers, which drives the price down as a result of competition, and because the brand name drug manufacturer needs to recoup advertising and research and development costs that the generic manufacturers do not. 

Summary

Sildenafil is an effective treatment option for men suffering from erectile dysfunction. The maximum dose of sildenafil is 100 mg, but many men find that the medication can effectively treat their condition at a lower dose. At higher doses, men are more likely to experience common side effects like headache and heartburn as well as rare but serious side effects like heart attack, stroke, and irregular heartbeat. Men with a history of heart problems or those taking certain medications may not be able to take sildenafil safely.

Sources:

https://pubmed.ncbi.nlm.nih.gov/19817982/ 

https://www.mayoclinic.org/diseases-conditions/erectile-dysfunction/symptoms-causes/syc-20355776

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Differences, similarities, and which is better for you

Drug overview & main differences | Conditions treated | Efficacy | Insurance coverage and cost comparison | Side effects | Drug interactions | Warnings | FAQ

If you are one of the 15 to 30 million men in the United States who suffers from erectile dysfunction, you may have talked with your doctor about trying a prescription medication. Levitra and Viagra are two popular medications used for the treatment of erectile dysfunction (ED). They are classified in a group of medications called PDE-5 (phosphodiesterase-5) inhibitors. Other drugs in this category include Cialis (tadalafil) and Stendra (avanafil).

PDE5 inhibitors work in conjunction with sexual stimulation—increasing the levels and activity of nitric oxide—leading to better blood flow to the penis and causing an erection. They also prolong erections and increase sexual satisfaction. Although Levitra and Viagra are both PDE-5 inhibitors and are very similar, they have some notable differences.

What are the main differences between Levitra and Viagra?

Levitra (vardenafil), also known by its generic name vardenafil, and Viagra, also known by its generic name, sildenafil, are both PDE-5 inhibitors. Both drugs are available in tablet form as brand and generic.

Regardless of dose, these medications should not be taken more than once in a day in the treatment of ED. Levitra or Viagra needs to be accompanied by sexual stimulation in order to work.

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Conditions treated by Levitra and Viagra

Levitra and Viagra are indicated for the treatment of erectile dysfunction. Both drugs have been used off-label for Raynaud’s phenomenon or for female sexual arousal disorder. The form of sildenafil known as Revatio (NOT Viagra) is indicated for the treatment of pulmonary arterial hypertension, only at the dose of 20 mg three times daily, and not at the doses Viagra is available in (25 mg, 50 mg, or 100 mg).

Is Levitra or Viagra more effective?

From clinical studies, we know that both Levitra and Viagra have been proven effective, but which is better? In a study comparing drugs for ED, Levitra was described as more potent than Viagra; however, both drugs were shown to be similarly effective in the treatment of ED. The only advantage Levitra had was that it did not alter color perception, which may occur with Viagra on rare occasions. Another study found both drugs to be well-tolerated, with Levitra being nominally better than Viagra.

The most effective drug for you can only be determined by your healthcare provider, who will take into account your medical history and condition(s), as well as other medications you are taking that could interact with Levitra or Viagra.

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Coverage and cost comparison of Levitra vs. Viagra

Insurance coverage varies widely for Levitra and Viagra. Many insurance companies do not cover these drugs, or may have a quantity limit (for example, four tablets per month).

A standard prescription of 10, 10 mg vardenafil (generic Levitra) tablets cost about $450 to over $500 without insurance. You can use a SingleCare coupon to get a prescription filled for as low as $365.

A standard prescription of 10, 50 mg sildenafil (generic Viagra) tablets is comparable to Levitra but a SingleCare discount card can reduce the price to $150-$300 depending on which pharmacy you use.

Common side effects of Levitra vs. Viagra

The most common side effects of Levitra and Viagra are headache, flushing, stuffy nose, and indigestion.

Other side effects may occur. This is not a complete list. Consult your ED healthcare provider for medical advice.

*Side effect percentages of Viagra vary by dosage
Source: DailyMed (Levitra), DailyMed (Viagra)

Drug interactions of Levitra vs. Viagra

Levitra and Viagra should never be used with nitrates, such as nitroglycerin. The combination is contraindicated (should not be used) because it could result in dangerously low blood pressure. Alpha blockers, such as alfuzosin, terazosin, or tamsulosin, can cause the same effect of low blood pressure when taken with Levitra or Viagra. Any antihypertensives (medications to lower blood pressure) in combination with Levitra or Viagra can also interact, causing low blood pressure.

Levitra or Viagra can also interact with azole antifungals, protease inhibitors, and macrolide antibiotics. Other drug interactions may occur; consult your healthcare professional for a full list of drug interactions.

Warnings of Levitra and Viagra

• Levitra or Viagra should not be given with any nitrate medication (such as nitroglycerin), because the combination can lead to a dangerous decrease in blood pressure.
• Cardiovascular health should be evaluated. If a patient has certain heart/blood pressure problems, the medication may be unsafe. Consult your healthcare provider.
• Use with caution in patients with anatomical deformations of the penis.
• Rarely, prolonged erection (over 4 hours) or priapism (painful erection over 6 hours) may occur. If an erection lasts longer than 4 hours, seek immediate medical care. Failing to treat this immediately could result in permanent damage.
• Stop taking Levitra or Viagra and seek immediate medical care if you have a sudden loss of vision in one or both eye(s). Although rare, this could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), which is a rare condition and a cause of decreased vision, which could lead to permanent vision loss.
• Stop taking Levitra or Viagra and seek immediate medical care if you have a sudden loss of hearing.
• Dosage adjustment is required for patients with moderate liver issues. Levitra or Viagra should not be used in patients with severe liver problems.
• Patients on dialysis should not use Levitra or Viagra.
• Because these medications do not protect against sexually transmitted diseases (STD), patients should use protective measures, such as condoms.

Although both drugs are indicated in men, they are sometimes used off-label in women. However, there is no data on either drug in pregnant women. Therefore, Levitra or Viagra should not be used in pregnant women.

Frequently asked questions about Levitra vs. Viagra

What is Levitra?

Levitra (vardenafil) is a prescription medication approved by the FDA for the treatment of erectile dysfunction (ED). The brand-name product is a Bayer product, and it is also available in generic by several manufacturers.

What is Viagra?

Viagra (sildenafil) is an FDA-approved prescription medication used to treat erectile dysfunction. The brand-name product is a Pfizer product, and it is also available in generic by several manufacturers.

You may have also heard of Revatio being used for ED in place of Viagra. Revatio is another drug that contains sildenafil, the same ingredient in Viagra. Revatio is indicated for the treatment of pulmonary arterial hypertension (PAH), and works by dilating the blood vessels in the lungs. Although Revatio is used for PAH, it is often prescribed off-label for ED. Sometimes, if insurance does not cover brand or generic Viagra, a doctor may prescribe Revatio, which is usually covered by insurance.

Are Levitra and Viagra the same?

Both drugs are in the same category of medications and work in the same way. However, some patients prefer one over the other. Ask your doctor if one of these drugs is right for you.

Is Levitra or Viagra better?

Both drugs are very similar in terms of efficacy, side effects, and drug interactions. Talk to your doctor to help you determine if Levitra or Viagra may be better for you.

Can I use Levitra or Viagra while pregnant?

Levitra and Viagra are not indicated for use in women but sometimes used off-label for female sexual arousal disorder. However, because there is no data about the use of these medications in pregnancy; Levitra or Viagra should not be used in pregnant women.

Can I use Levitra or Viagra with alcohol?

Alcohol can reduce the chance of getting an erection, so it is advisable not to take Levitra or Viagra with alcohol.

Is 20 mg Levitra equal to 100 mg Viagra?

The highest dose of Levitra is 20 mg, and the highest dose of Viagra is 100 mg. That being said, Levitra tends to be more potent than Viagra, and may require a lower dose. Your doctor can help you determine the dose that is right for you.

Does Levitra have fewer side effects than Viagra?

The side effects of Levitra and Viagra are similar, and seem to occur at similar rates, although more side effects may occur at higher doses.

Can you mix Viagra with Levitra?

Taking two ED medications together is not recommended. If you are taking an ED medication that is not working, talk to your doctor about trying a different one, and/or consider lifestyle factors.

Is Cialis stronger than Viagra?

Cialis lasts up to about 18 hours, while Viagra lasts up to about 6 hours. Both drugs seem to be similarly effective, but the effects of Cialis lasts longer.

What is the most effective ED drug?

All of the ED drugs have been shown to be effective in clinical studies. Talk to your doctor to determine if an ED drug is appropriate for you.

Viagra instructions for use, price in pharmacies in Ukraine, analogues, composition, indications | Viagra by Upjohn US 1 LLS

pharmacodynamics.

Mechanism of action. Sildenafil is an oral drug for the treatment of erectile dysfunction. With sexual arousal, the drug renews reduced erectile function by increasing blood flow to the penis.

The physiological mechanism of penile erection is the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.The released nitric oxide activates the enzyme guanylate cyclase, which stimulates an increase in cGMP levels, which, in turn, causes relaxation of the smooth muscles of the corpora cavernosa, promoting increased blood flow.

Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase-5 (PDE-5) in the corpus cavernosum, where PDE-5 is responsible for the breakdown of cGMP. The effects of sildenafil on erection are peripheral. Sildenafil does not have a direct relaxing effect on the isolated human corpus cavernosum, but it potently enhances the relaxing effect of NO on this tissue.When the NO / cGMP metabolic pathway is activated, which occurs during sexual stimulation, inhibition of PDE-5 by sildenafil leads to an increase in the level of cGMP in the corpus cavernosum. Thus, in order for sildenafil to produce the desired pharmacological effect, sexual arousal is necessary.

Effect on pharmacodynamics . Studies in vitro demonstrated the selectivity of the effect of sildenafil on PDE-5, which is actively involved in the process of erection. The effect of sildenafil on PDE-5 is more potent than on other known PDEs.This effect is 10 times more powerful than the effect on PDE-6, which is involved in photoconversion processes in the retina. When using the maximum recommended doses, the selectivity of sildenafil to PDE-5 is 80 times higher than its selectivity to PDE-1, 700 times higher than to PDE-2, PDE-3, PDE-4, PDE-7, PDE-8, PDE -9, PDE-10 and PDE-11. In particular, the selectivity of sildenafil for PDE-5 is 4000 times higher than its selectivity for PDE-3, a cGMP-specific isoform of PDE, which is involved in the regulation of heart contractions.

Pharmacokinetics

Absorption. Sildenafil is rapidly absorbed. C _max of the drug in blood plasma is achieved within 30–120 minutes (with a median of 60 minutes) after oral administration on an empty stomach. The average absolute bioavailability after oral administration is 41% (with a range of 25–63%). In the recommended dose range (25-100 mg), AUC and Cmax _max sildenafil after oral administration increase in proportion to the dose.

When using sildenafil during meals, the degree of absorption decreases with an average elongation T _max up to 60 minutes and an average decrease in C _max by 29%.

Distribution. The average equilibrium volume of distribution (V _d ) is 105 liters, which indicates the distribution of the drug in the tissues of the body. After a single oral administration of sildenafil at a dose of 100 mg, the average C _max of sildenafil is about 440 ng / ml (the coefficient of variation is 40%).Since the binding of sildenafil and its main N-desmethyl metabolite with blood plasma proteins reaches 96%, the average C _max of free sildenafil reaches 18 ng / ml (38 nmol). The degree of binding to blood plasma proteins does not depend on the total concentration of sildenafil.

In healthy volunteers who used sildenafil at a single dose of 100 mg, after 90 minutes, <0.0002% (on average - 188 ng) of the applied dose was determined in the ejaculate.

Biotransformation. Sildenafil metabolism is carried out mainly with the participation of microsomal liver isoenzymes CYP 3A4 (main pathway) and CYP 2C9 (secondary pathway).The main circulating metabolite is formed by the N-demethylation of sildenafil. The selectivity of the metabolite in relation to PDE-5 is comparable to that of sildenafil, and the activity of the metabolite in relation to PDE-5 is approximately 50% of the activity of the parent substance. Plasma concentrations of this metabolite are approximately 40% of the plasma concentrations of sildenafil. The N-demethylated metabolite undergoes further metabolism, and T90,027 ½ is approximately 4 hours.

Elimination. The total clearance of sildenafil is 41 l / h, predetermining T90,027 ½ lasting 3-5 hours. Both after oral administration and after intravenous administration, the excretion of sildenafil in the form of metabolites is carried out mainly with feces (about 80% of the administered oral dose ) and, to a lesser extent, with urine (about 13% of the administered oral dose).

Pharmacokinetics in special patient groups

Elderly patients. In healthy elderly volunteers (aged ≥65 years), there was a decrease in the clearance of sildenafil, which predetermined an increase in plasma concentrations of sildenafil and its active N-demethylated metabolite by approximately 90% compared with the corresponding concentrations in healthy young volunteers (18-45 years ). Due to age-related differences in binding to blood plasma proteins, the corresponding increase in plasma concentration of free sildenafil was about 40%.

Renal failure. In volunteers with mild to moderate renal impairment (creatinine clearance 30–80 ml / min), the pharmacokinetics of sildenafil remained unchanged after a single oral dose of 50 mg. The average AUC and C _max of the N-demethylated metabolite increased by 126 and 73%, respectively, compared with such indicators in volunteers of the same age without impaired renal function. However, due to the high interindividual variability, these differences were not statistically significant.In volunteers with severe renal impairment (creatinine clearance <30 ml / min), sildenafil clearance decreased, which led to average increases in AUC and C _max by 100 and 88%, respectively, compared with volunteers of the same age without renal impairment. In addition, the values ​​of AUC and C _max of the N-demethylated metabolite were significantly increased by 200 and 79%, respectively.

Liver failure. In volunteers with mild to moderate liver cirrhosis (classes A and B according to the Child-Pugh classification), the clearance of sildenafil decreased, which led to an increase in AUC (84%) and C _max (47%) compared with volunteers of a similar age without liver dysfunctions.The pharmacokinetics of sildenafil in patients with severe hepatic impairment have not been studied.

Viagra is recommended for men with erectile dysfunction, which is defined as the inability to achieve or maintain an erection of the penis necessary for successful intercourse.

For the effective action of the drug Viagra, sexual arousal is necessary.

Viagra . The drug is intended for oral administration.

Viagra ODT .The drug is administered orally.

The drug should be used immediately after the tablet is taken out of the blister. The tablet should be put on the tongue, wait for it to disintegrate, and then swallowed. The drug can be taken with or without water.

If it is necessary to use a dose of 100 mg, the second tablet should be taken only after the first tablet has completely disintegrated.

It is recommended to use the drug on an empty stomach, since when the drug is used simultaneously with fatty foods, there is a significant delay in absorption compared to the use of tablets on an empty stomach.

Viagra and Viagra ODT .

Adults. The recommended adult dose is 50 mg, which is taken as needed approximately 1 hour before intercourse. Given the efficacy and tolerability, the dose can be increased to 100 mg or reduced to 25 mg. The maximum recommended dose is 100 mg.

The frequency of application of the maximum recommended dose of the drug is 1 time per day. When using the drug Viagra during a meal, the effect of the drug may occur later than when it is used on an empty stomach.

If it is necessary to use a dose of 25 mg, it is recommended to use sildenafil, 25 mg film-coated tablets.

Elderly patients. There is no need for dose adjustment in elderly patients (≥65 years).

Patients with renal failure. For patients with renal insufficiency of mild and moderate severity (creatinine clearance 30–80 ml / min), the recommended dose is the same as indicated above in the section “Adults”.

Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml / min), use of the drug should be started with a dose of 25 mg. Depending on the effectiveness and tolerability of the drug, the dose can be increased to 50 and 100 mg.

Patients with liver failure. Since the clearance of sildenafil is reduced in patients with hepatic impairment, for example, in cirrhosis, the use of the drug should be started with a dose of 25 mg.Depending on the effectiveness and tolerability of the drug, the dose can be increased to 50 and 100 mg.

Patients undergoing other treatments. If patients are concomitantly using CYP 3A4 inhibitors (see INTERACTIONS), an initial dose of 25 mg should be considered (with the exception of ritonavir, which is not recommended concomitantly with sildenafil, see SPECIAL INSTRUCTIONS and INTERACTIONS).

In order to minimize the risk of orthostatic hypotension, the condition of patients using α-adrenergic receptor blockers should be stabilized before starting the use of sildenafil.You should also consider the possibility of using an initial dose of sildenafil 25 mg (see SPECIAL INSTRUCTIONS and INTERACTIONS).

• hypersensitivity to the active substance or any other component of the drug.
• Concomitant use with NO donors (such as amyl nitrite) or nitrates in any form is contraindicated, since sildenafil is known to affect the NO / cGMP pathways and potentiate the hypotensive effect of nitrates.
• The concomitant use of PDE-5 inhibitors (including sildenafil) with guanylate cyclase stimulants such as riociguat is contraindicated because it can cause symptomatic hypotension (see.INTERACTIONS).
• Conditions in which sexual activity is not recommended (eg, severe cardiovascular disease such as unstable angina or severe heart failure).
• Loss of vision in one eye due to non-arterial anterior ischemic neuropathy of the optic nerve, regardless of whether this pathology is associated with previous use of PDE5 inhibitors or not.
• The presence of the following diseases: severe liver dysfunction, arterial hypotension (BP <90/50 mm Hg.Art.), recent stroke or myocardial infarction and known hereditary degenerative retinal diseases such as retinitis pigmentosa (a small number of such patients have genetic disorders of the retinal PDE), since the safety of sildenafil has not been studied in patients of these subgroups.

The safety profile of Viagra is based on data obtained from 9570 patients in 74 placebo-controlled clinical trials. The most commonly reported adverse reactions were headache, flushing, dyspepsia, visual disturbances, nasal congestion, back pain, dizziness, nausea, hot flashes, blurred vision, cyanopsia, and blurred vision.Information on adverse reactions in the framework of post-marketing surveillance was collected over a period of more than 10 years. Since not all adverse reactions were reported to the applicant and not all adverse reactions were included in the safety database, the frequency of such reactions cannot be reliably determined.

All clinically significant adverse reactions that were observed in clinical trials more often than with placebo are shown in the table below in accordance with the system-organ-class classification and frequency: very often (≥1 / 10), often (≥100 and <1/10), infrequently (≥1000 and <1/100) and rarely (≥10,000 and <1/1000).Within each frequency group, adverse reactions are listed in order of decreasing severity.

Infectious and invasive diseases .

Uncommon: rhinitis.

From the immune system .

Uncommon: hypersensitivity.

From the nervous system .

Very common: headache.

Often: dizziness.

Uncommon: drowsiness, hypesthesia.

Rare: stroke, transient ischemic attack, seizures *, recurrent seizures *, syncope.

From the side of the organ of vision .

Often: impaired color perception **, visual disturbances, blurred vision.

Uncommon: lacrimation disorders ***, eye pain, photophobia, photopsia, redness of the eyes, brightness of vision, conjunctivitis.

Rare: non-arterial anterior ischemic neuropathy of the optic nerve *, retinal vascular occlusion *, retinal hemorrhage, arteriosclerotic retinopathy, retinal disorders, glaucoma, visual field defects, diplopia, decreased visual acuity, myopia, asthenopia, floating body opacities, vitreous disorders sides of the iris, mydriasis, the appearance of luminous circles around the light source (halo) in the field of view, eye edema, eye swelling, eye disorders, conjunctival hyperemia, eye irritation, abnormal sensations in the eyes, eyelid edema, scleral discoloration.

From the side of the organ of hearing and vestibular apparatus .

Uncommon: dizziness, ringing in the ears.

Rarely: deafness.

From the side of the heart .

Uncommon: tachycardia, increased heart rate.

Rare: sudden coronary death *, myocardial infarction, ventricular arrhythmia *, atrial fibrillation, unstable angina pectoris.

From the side of the vessels .

Often: flushing of the face, hot flushes.

Uncommon: hypertension, hypotension.

From the respiratory system, chest and mediastinum .

Often: nasal congestion.

Uncommon: epistaxis, sinus congestion.

Rare: a feeling of constriction in the throat, swelling of the nasal mucosa, dryness in the nose.

From the gastrointestinal tract .

Often: nausea, dyspepsia.

Uncommon: gastroesophageal reflux disease, vomiting, pain in the upper abdomen, dry mouth.

Rare: oral hypoesthesia.

Skin and subcutaneous tissue disorders .

Uncommon: rash.

Rare: Stevens-Johnson syndrome *, toxic epidermal necrolysis *.

From the side of the musculoskeletal system and connective tissue .

Uncommon: myalgia, pain in the limbs.

From the urinary system .

Uncommon: hematuria.

From the reproductive system and mammary glands .

Rare: bleeding from the penis, priapism *, hematospermia, prolonged erection.

General disorders and reactions at the injection site .

Uncommon: chest pain, increased fatigue, feeling of heat.

Rare: irritation.

Survey .

Uncommon: tachycardia.

* Reported only during post-market study.

** Disorder of color perception: chloropsia, chromatopsia, cyanopsia, erythropsia, xanthopsia.

*** Disorder of lacrimation: dry eyes, impaired lacrimation and increased lacrimation.

The following events have been observed in <2% of patients in controlled clinical trials; the causal relationship has not been determined. The reports included events that were likely to be related to the use of the drug. The phenomena that were not listed were light and the reports were very inaccurate to make a difference.

General : facial edema, photosensitivity, shock, asthenia, pain, sudden fall, abdominal pain, sudden injury.

From the cardiovascular system : angina pectoris, AV blockade, migraine, postural hypotension, myocardial ischemia, cerebral vascular thrombosis, sudden cardiac arrest, abnormal ECG results, cardiomyopathy.

From the gastrointestinal tract : glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, impaired liver function tests, rectal bleeding, gingivitis.

From the side of the blood and lymphatic system : anemia, leukopenia.

Disorders of metabolism and nutrition : thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia.

From the musculoskeletal system : arthritis, arthrosis, tendon rupture, tenosynovitis, bone pain, myasthenia gravis, synovitis.

From the nervous system : ataxia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, abnormal dreams, decreased reflexes.

From the respiratory system : BA, shortness of breath, laryngitis, pharyngitis, sinusitis, bronchitis, increased salivation, increased cough.

On the part of the skin : urticaria, herpes, itching, sweating, skin ulcers, contact dermatitis, exfoliative dermatitis.

Specific sensations : sudden hearing loss or loss, ear pain, bleeding in the eye, cataracts, dry eyes.

On the part of the urogenital system : cystitis, nocturia, increased frequency of urination, breast enlargement, urinary incontinence, ejaculation disorder, genital edema, anorgasmia.

Application experience after market launch . After the drug was launched on the market, the following adverse reactions were identified. Since these reactions are voluntarily reported and reported from populations of unknown size, it is not always possible to reliably estimate their frequency and establish a causal relationship to drug exposure. These phenomena were noted both because of their severity, frequency of reporting, lack of clear alternative link, and through a combination of these factors.

Cardiovascular and cerebrovascular phenomena . Serious cardiovascular, cerebrovascular and vascular events have been reported, including cerebrovascular bleeding, subarachnoid and intracerebral bleeding and pulmonary hemorrhage, which were associated in time with the use of Viagra. Most of the patients, but not all, had existing cardiovascular risk factors. It has been reported that many of these phenomena occurred during or immediately after sexual activity, and several phenomena occurred immediately with the use of Viagra without sexual activity.Other phenomena occurred within the next hours or days after the use of Viagra and sexual activity. It is impossible to establish whether these phenomena are directly related to the use of the drug, with sexual activity, with existing risk factors or with a combination of these factors, or with other factors.

Circulatory and lymphatic systems : vaso-occlusive crisis. In a small, pre-suspended study of the use of the drug Revazio (sildenafil) for patients with pulmonary hypertension secondary to sickle cell anemia, with sildenafil, the development of vaso-occlusive crises that required hospitalization was reported more often than with placebo.The clinical significance of this information for patients taking Viagra for the treatment of erectile dysfunction is unknown.

Nervous system : alarm, transient global amnesia.

Specific sensations

Hearing . After the drug was launched on the market, cases of sudden hearing loss or loss associated with the use of Viagra were reported. In some cases, the presence of medical conditions and other factors have been reported that may play a role in the development of adverse reactions from hearing.In many cases, there is no information on further medical follow-up. It is impossible to determine whether these phenomena are directly related to the use of Viagra, with existing risk factors for hearing loss, with a combination of these factors or with other factors.

Vision: temporary loss of vision, redness of the eyes, burning in the eyes, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, detachment of the vitreous humor.

After the drug was launched on the market, cases of non-arterial anterior ischemic neuropathy of the optic nerve were rarely reported, which is the cause of visual impairment, including permanent loss of vision, which were associated with the use of PDE-5 inhibitors, including Viagra.Many, but not all, of the patients had anatomical or vascular risk factors for developing non-arterial anterior ischemic optic neuropathy, including, but not necessarily limited to: a low excavation diameter to optic nerve head (stagnant optic disc) ratio, age over 50 , hypertension, coronary artery disease, hyperlipidemia, and smoking. It is impossible to determine whether these events are directly related to the use of PDE-5 inhibitors or with existing anatomical or vascular risk factors, or with a combination of all of these factors, or with other factors.

Suspected Adverse Reactions Report. Reporting suspected adverse reactions after registration of a medicinal product is essential. This allows continuous monitoring of the balance between benefits and risks associated with the use of this drug. Physicians should report any suspected adverse reactions as required by law.

Before starting therapy, it is necessary to collect a medical history from the patient and conduct a physical examination to diagnose erectile dysfunction and determine its possible causes.

Risk factors for cardiovascular diseases . Since sexual activity is accompanied by a certain risk from the heart, the doctor should assess the state of the cardiovascular system before starting any treatment for a patient with erectile dysfunction. Sildenafil has a vasodilating effect, which is manifested by a mild and short-term decrease in blood pressure. Before prescribing sildenafil, the physician should carefully consider whether such an effect could have an adverse effect on patients with certain underlying medical conditions, especially in combination with sexual activity.Persons with hypersensitivity to vasodilators include patients with obstruction of the left ventricular outflow tract (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy) or patients with a rare syndrome of multisystem atrophy, one of the manifestations of which is severe impairment of blood pressure regulation by the autonomic nervous system.

Viagra potentiates the hypotensive effect of nitrates (see CONTRAINDICATIONS).

In the post-marketing period, serious adverse reactions from the cardiovascular system were reported, including myocardial infarction, unstable angina pectoris, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension and arterial hypotension, which coincided in time with the use of the drug …Most, but not all, patients had cardiovascular risk factors. Many of these adverse reactions were observed during or immediately after intercourse, and only a few – soon after using the drug without sexual activity. Therefore, it is impossible to determine whether the development of such adverse reactions is directly related to risk factors, or their development is due to other factors.

Priapism. Drugs for the treatment of patients with erectile dysfunction, including sildenafil, should be prescribed with caution to persons with anatomical deformities of the penis (such as angulation, cavernous fibrosis, or Peyronie’s disease), or to patients with conditions that contribute to the development of priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

Cases of prolonged erection and priapism have been reported since the drug was launched. If an erection lasts more than 4 hours, patients should seek immediate medical attention. In the absence of immediate treatment, priapism can damage the tissues of the penis and lead to a permanent loss of potency.

Simultaneous use with other PDE-5 inhibitors or other drugs for the treatment of erectile dysfunction. The safety and efficacy of concomitant use of sildenafil with other PDE-5 inhibitors or other drugs for the treatment of pulmonary artery hypertension containing sildenafil (eg Revacio), or with other drugs for the treatment of erectile dysfunction have been studied.Therefore, the use of such combinations is not recommended.

Effect on vision . Spontaneous reports of visual defects have been reported associated with the use of sildenafil and other PDE-5 inhibitors (see SIDE EFFECTS). Cases of non-arterial anterior ischemic optic neuropathy, a rare condition, have been spontaneously reported and reported in a surveillance study associated with sildenafil and other PDE5 inhibitors (see section 4.4).SIDE EFFECTS). Patients should be warned that in case of sudden visual impairment, the use of Viagra should be discontinued and immediately consult a doctor (see CONTRAINDICATIONS).

Co-administration with ritonavir . Concomitant use of sildenafil and ritonavir is not recommended (see INTERACTIONS).

Simultaneous use of α-adrenergic receptor blockers . Patients taking α-adrenergic receptor blockers should use sildenafil with caution, since this combination can lead to symptomatic hypotension in some predisposed patients.Symptomatic hypotension usually occurs within 4 hours after using sildenafil. In order to minimize the possible development of postural hypotension in patients taking α-adrenergic receptor blockers, their condition must be stabilized with α-adrenergic receptor blockers before starting the use of sildenafil. You should also consider using an initial dose of 25 mg (see APPLICATION). In addition, patients should be informed how to act in the event of symptoms of orthostatic hypotension.

Effect on bleeding . The results of a study of human platelets indicate that in vitro sildenafil potentiates the antiaggregatory effects of sodium nitroprusside. There is no information on the safety of using sildenafil in patients with bleeding disorders or acute gastrointestinal ulcers. Thus, the use of sildenafil in patients of this group is possible only after a careful assessment of the benefit / risk ratio.

The film-coated tablets contain lactose.Viagra should not be used by men with rare hereditary disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Hearing loss . Physicians should advise patients to stop using PDE-5 inhibitors, including Viagra, and seek immediate medical attention in cases of sudden hearing loss or loss. These phenomena, which can also be accompanied by tinnitus and dizziness, have been reported with an association in time with the use of PDE-5 inhibitors, including Viagra.It is impossible to determine whether these phenomena are directly related to the use of PDE-5 inhibitors or to other factors.

Simultaneous use with antihypertensive drugs . Viagra has a systemic vasodilator effect and can further lower blood pressure in patients using antihypertensive drugs. In a separate study of the drug interaction of the simultaneous use of amlodipine (5 or 10 mg) and the drug Viagra (100 mg) orally, an additional average decrease in systolic blood pressure of 8 mm Hg was observed.Art. and diastolic blood pressure – by 7 mm Hg. Art.

Sexually transmitted diseases . The use of the drug Viagra does not protect against sexually transmitted diseases. Consideration should be given to instructing patients on the necessary precautions to be taken to protect against sexually transmitted diseases, including HIV.

Fertility . No effect on sperm morphology or motility was observed after ingestion of 100 mg by healthy volunteers (see.Pharmacodynamics).

Pregnancy and breastfeeding . Viagra is not intended for use in women.

Children. Not indicated for use by persons under the age of 18.

The ability to influence the reaction speed when driving or working with mechanisms. Studies of the effect of the drug on the ability to drive vehicles and work with mechanisms have not been carried out.

Since in clinical studies of the use of sildenafil, cases of dizziness and visual disturbances have been reported, before getting behind the wheel of a vehicle or working with mechanisms, patients need to find out their individual reaction to the use of Viagra.

effect of other drugs on sildenafil

In vitro study

Sildenafil metabolism occurs predominantly with the participation of isoform 3A4 (major pathway) and isoform 2C9 (minor pathway) of cytochrome P450 (CYP).Therefore, inhibitors of these isoenzymes are able to reduce the clearance of sildenafil.

In vivo study

Population pharmacokinetic analysis of clinical trial data showed a decrease in the clearance of sildenafil when used simultaneously with CYP 3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine). Although no increase in the frequency of side effects has been identified with the simultaneous use of sildenafil and CYP 3A4 inhibitors, the recommended starting dose of sildenafil is 25 mg.

The simultaneous use of the HIV protease inhibitor ritonavir, a very potent inhibitor of P450, in a state of equilibrium concentration (500 mg once a day) and sildenafil (a single dose of 100 mg) led to an increase in C _max sildenafil by 300% (4 times) and an increase in the plasma AUC of sildenafil by 1000% (11 times). At 24 hours, plasma levels of sildenafil were still about 200 ng / ml, compared with about 5 ng / ml for sildenafil alone, consistent with the significant effect of ritonavir on a wide range of P450 substrates.Sildenafil does not affect the pharmacokinetics of ritonavir. Given these pharmacokinetic data, concomitant use of sildenafil and ritonavir is not recommended; in any case, the maximum dose of sildenafil should under no circumstances exceed 25 mg over 48 hours.

The simultaneous use of the HIV protease inhibitor saquinavir, an inhibitor of CYP 3A4, in a dose that provides an equilibrium concentration (1200 mg 3 times a day), and sildenafil (100 mg once) led to an increase in C _max sildenafil by 140% and an increase in systemic exposure (AUC) of sildenafil by 210%.No effect of sildenafil on the pharmacokinetics of saquinavir was found. More potent CYP 3A4 inhibitors such as ketoconazole and itraconazole are expected to have a more pronounced effect.

With the use of sildenafil (100 mg once) and erythromycin, a specific inhibitor of CYP 3A4, in an equilibrium state (500 mg twice a day for 5 days), an increase in the AUC of sildenafil by 182% was observed. In healthy male volunteers, there was no effect of azithromycin (500 mg / day for 3 days) on AUC, C _max , T _max , elimination rate constant and further T _½ of sildenafil or its main circulating metabolite.Cimetidine (an inhibitor of cytochrome P450 and a nonspecific inhibitor of CYP 3A4) at a dose of 800 mg, when used simultaneously with sildenafil at a dose of 50 mg in healthy volunteers, led to an increase in plasma concentrations of sildenafil by 56%.

Grapefruit juice is a weak inhibitor of CYP 3A4 in the intestinal wall and may cause a moderate increase in plasma levels of sildenafil.

Single use of antacids (magnesium hydroxide / aluminum hydroxide) does not affect the bioavailability of sildenafil.

Although studies of specific interaction with all drugs have not been conducted, according to population pharmacokinetic analysis, the pharmacokinetics of sildenafil did not change when it was used simultaneously with drugs that belong to the group of CYP 2C9 inhibitors (tolbutamide, warfarin, phenytoin), the group of CYP 2D6 inhibitors ( such as selective serotonin reuptake inhibitors, tricyclic antidepressants), a group of thiazide and thiazide-like diuretics, loop and potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, calcium antagonists, antagonists of β-adrenergic receptors (CYP), or inducers of ripple inhibitors (such as ripple metabolism) 450.

In a study with healthy male volunteers, the simultaneous use of the endothelin antagonist bosentan (a moderate inducer of CYP 3A4, CYP 2C9 and possibly CYP 2C19) in an equilibrium state (125 mg 2 times a day) and sildenafil in an equilibrium state (80 mg 3 times a day) led to a decrease in AUC and C _max sildenafil by 62.6 and 55.4%, respectively. Therefore, the simultaneous use of such powerful inducers of CYP 3A4 as rifampicin can lead to a more pronounced decrease in the concentration of sildenafil in blood plasma.

Nicorandil is a hybrid of a calcium channel activator and nitrate. The nitrate component determines the possibility of its serious interaction with sildenafil.

Effect of sildenafil on other medicinal products

In vitro study

Sildenafil is a weak inhibitor of isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC ₅₀ > 150 μmol) of cytochrome P450. Since the C _max of sildenafil is approximately 1 μmol, the effect of Viagra on the clearance of substrates of these isoenzymes is unlikely.

There are no data on the interaction of sildenafil and such nonspecific PDE inhibitors as theophylline and dipyridamole.

In vivo study

Since it is known that sildenafil has an effect on the metabolism of nitric oxide / cGMC, it was found that this drug potentiates the hypotensive effect of nitrates, therefore, its simultaneous use with nitric oxide donors or with nitrates in any form is contraindicated (see CONTRAINDICATIONS).

Rioziguat. Preclinical studies have shown an additive systemic effect of lowering blood pressure with the simultaneous use of PDE-5 inhibitors with riociguat. Clinical studies have shown that riociguat enhances the hypotensive effect of PDE-5 inhibitors. In patients participating in the study, no clinical effect was observed with the simultaneous use of PDE-5 inhibitors with riociguat. The simultaneous use of riociguat with PDE-5 inhibitors (including sildenafil) is contraindicated (see.CONTRAINDICATIONS).

The simultaneous use of sildenafil and blockers of α-adrenergic receptors can lead to the development of symptomatic hypotension in some predisposed patients. This reaction often occurred within 4 hours after the use of sildenafil (see APPLICATION and SPECIAL INSTRUCTIONS). In the course of 3 studies of the specific interaction of drugs with α-adrenergic receptor blockers doxazosin (4 and 8 mg) and sildenafil (25; 50 and 100 mg), used simultaneously in patients with benign prostatic hyperplasia, stabilization of which was achieved with the use of doxazosin.In these populations, an average additional reduction in blood pressure in the supine position of 7/7 was observed; 9/5 and 8/4 mm Hg. Art. and an average decrease in blood pressure in the standing position by 6/6; 11/4 and 4/5 mm Hg. Art. respectively. With the simultaneous use of sildenafil and doxazosin in patients whose condition stabilization was achieved with the use of doxazosin, the development of symptomatic orthostatic hypotension was sometimes reported. These reports reported cases of dizziness and lightheadedness, but no syncope.

No significant interactions were observed with the simultaneous use of sildenafil (50 mg) and tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by CYP 2C9.

Sildenafil (50 mg) did not lead to an increase in bleeding time caused by the use of acetylsalicylic acid (150 mg).

Sildenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers at an average maximum blood ethanol level of 80 mg / dL.

In patients taking sildenafil, there were no differences in the profile of side effects compared to placebo with the simultaneous use of such classes of antihypertensive drugs as diuretics, β-adrenergic blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive drugs (vasodilators and central action ), blockers of adrenergic neurons, blockers of calcium channels and blockers of α-adrenergic receptors.In a special study of the interaction with the simultaneous use of sildenafil (100 mg) and amlodipine in patients with hypertension, an additional decrease in systolic blood pressure in the supine position by 8 mm Hg was noted. Art. The corresponding decrease in diastolic blood pressure was 7 mm Hg. Art. In terms of magnitude, these additional reductions in blood pressure were comparable to those observed with sildenafil alone in healthy volunteers (see PHARMACOLOGICAL PROPERTIES).

Sildenafil at a dose of 100 mg did not affect the pharmacokinetic parameters of HIV protease inhibitors, saquinavir and ritonavir, which are substrates of CYP 3A4.

In healthy male volunteers, the use of sildenafil in an equilibrium state (80 mg 3 times a day) led to an increase in AUC and C _max bosentan (125 mg 2 times a day) by 49.8 and 42%, respectively.

in studies on healthy volunteers with a single dose of the drug in doses up to 800 mg, side effects were similar to those observed when taking Viagra in lower doses, but the frequency and severity increased.

The use of sildenafil at a dose of 200 mg did not lead to an increase in efficacy, but caused an increase in the number of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, visual disturbances).

In case of overdose, use usual supportive measures as needed. An acceleration of the clearance of sildenafil during hemodialysis is unlikely due to the high degree of binding of the drug to blood plasma proteins and the lack of elimination of sildenafil in the urine.

at a temperature not exceeding 30 ° C, out of the reach of children.

Added date: 10/29/2021

VIAGRA 0.1 N1 TABLE P / PLEN / SHELL

Viagra 100 mg 4 tablets – Russian Pharmacy in Egypt

Trade name:

Viagra

Viagra

Ingredients:

Each tablet contains:

Sildenafil 100mg

Auxiliary components:

ludiflesh, mannitol, crospovidone, polyvinyl acetate, povidone, croscarmellose sodium, microcrystalline cellulose, colloidal silicon dioxide, sucralose, indigo carmine.

Properties:

Sildenafil is a potent selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5).

Realization of the physiological mechanism of erection is associated with the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. This, in turn, leads to an increase in cGMP levels, subsequent relaxation of the smooth muscle tissue of the corpus cavernosum and an increase in blood flow.

Sildenafil does not have a direct relaxing effect on the isolated human corpus cavernosum, but enhances the effect of NO by inhibiting PDE5, which is responsible for the breakdown of cGMP.

Sexual stimulation is a prerequisite for the effectiveness of sildenafil. Sildenafil restores impaired erectile function under conditions of sexual stimulation by increasing blood flow to the corpora cavernosa of the penis.

Readings:

Treatment of erectile dysfunction characterized by an inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse. Sildenafil is only effective for sexual stimulation.

Method of administration and dosage:

The doctor determines the optimal dosage regimen. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Treatment of erectile dysfunction: taken orally about 1 hour before the planned sexual activity. A single dose is 50 mg. Taking into account the effectiveness and tolerability, the dose can be increased to 100 mg or reduced to 25 mg. The maximum single dose is 100 mg.The maximum frequency of use is 1 time / day. For elderly patients over the age of 65 and with concomitant renal or hepatic impairment, the dose is 25 mg.

Contraindications:

Simultaneous intake of nitric oxide or nitrate donors in any form, hypersensitivity to sildenafil.

Precautions:

Before starting to take sildenafil for the treatment of erectile dysfunction, a cardiovascular examination should be performed.

Use with caution in patients with a tendency to bleeding, with gastric ulcer and duodenal ulcer in the acute phase, with hereditary retinitis pigmentosa.

Sildenafil is not used in patients under the age of 18.

Side Effects:

From the side of the central nervous system: possible headache, hot flashes, dizziness, insomnia.

From the digestive system: possible dyspepsia, asthenia, diarrhea, abdominal pain, nausea.

Storage method:

In a cool dry place at a temperature not exceeding 30 degrees.

Packing:

Cardboard box holds 1 blister of 4 tablets, paper instructions.

Viagra (Viagra): description, recipe, instruction

Viagra

Analogs (generics, synonyms)

Active ingredient

Sildenafil

Pharmacological group

PDE-5 inhibitors, Potency regulators

Recipe

International:

Rp.Tabl. “Viagra” 100 mg No. 2
D.S. 1 tablet approximately 1 hour before sexual activity

Russia:

Rp: Sildenafili 100 mg

D.t.d. No. 1 in tab.

S. 1 tablet one hour before intercourse.

Prescription form 107-1 / y

Pharmacological action

The drug restores the normal response to sexual arousal.
The physiological mechanism itself, which ensures an erection, is impossible without the release of nitric oxide in the corpus cavernosum during sexual stimulation.NO activates a special enzyme called guanylate cyclase, which increases the level of cGMP (cyclic guanosine monophosphate), relaxes the muscles of the corpus cavernosum and increases blood flow to the genitals.

Sildenafil – the active substance of VIAGRA, is a selective inhibitor of PDE5 (phosphodiesterase type 5), which ensures the breakdown of cGMP in the corpus cavernosum. The drug is characterized by a peripheral effect on penile erection. It is noteworthy that sildenafil does not relax the corpora cavernosa directly, but uses the relaxing function of nitric oxide.It is known that sexual irritation is necessary for a useful pharmacological action of the drug.

The drug was well tolerated and did not cause clinically significant deviations in healthy subjects with a single use in an amount not exceeding 100 mg.

Pharmacodynamics

There is no data for this section. We are currently processing information, please come back later.

Pharmacokinetics

There is no data for this section.We are currently processing information, please come back later.

Method of application

For adults:

The tablets of this drug are taken orally, about one hour before the planned sexual intercourse.

The optimal single dose for adults is 50 mg once a day. Given the individual tolerance and effectiveness of the drug, the dose can be reduced to 25 mg or increased to 100 mg. 100 mg per day is the maximum single dose.

For the elderly, there is no need to change the standard dosage.

In case of mild and moderate renal failure (CC 30-80 ml / min), dose adjustment is not required; in severe renal failure (CC <30 ml / min), the dose of sildenafil should be reduced to 25 mg.

Readings

Treatment of erectile dysfunction, characterized by an inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse.Sildenafil is only effective for sexual stimulation.

Contraindications

The drug is contraindicated in persons with hypersensitivity to the components of the drug and with anatomical deformities of the penis (Peyronie’s disease, cavernous fibrosis, angulation).

Also, you should not use this drug for the following violations:
– increased tendency to bleeding;
– exacerbation of peptic ulcer of the gastrointestinal tract;
– liver dysfunction, especially severe renal failure or cirrhosis;
– diseases that develop priapism, including leukemia, multiple myeloma and sickle cell anemia;
– severe form of hypotension or arterial hypertension; various heart diseases, including unstable angina pectoris, arrhythmias in a dangerous form and heart failure.

If the patient has experienced a stroke or myocardial infarction, then the drug should not be used in the next six months. Viagra is also not prescribed for children. The simultaneous use of this drug with nitrates and nitric oxide donors is strictly prohibited. Men who are contraindicated in sexual activity should not prescribe Viagra.

Special instructions

There is no data for this section. We are currently processing information, please come back later.

Side effects

– If you are allergic to sildenafil or any of the ingredients in this drug.

– If you are taking drugs called nitrates, as the combination of these drugs with sildenafil can lead to a dangerous drop in blood pressure. Tell your healthcare provider if you are currently taking any of these drugs (these drugs are often prescribed to treat angina (or “chest pain”)).If you are unsure, check with your healthcare professional or pharmacist for this information.

– If you are taking nitric oxide donor drugs, such as amyl nitrite (called popers), as the combination of these drugs with sildenafil can cause a dangerous drop in your blood pressure. – If you have serious heart or liver problems.
– If you have recently had a stroke or heart attack, or have low blood pressure.
– If you suffer from rare hereditary eye diseases (such as retinitis pigmentosa).
– If you have ever lost your vision due to the development of anterior ischemic neuropathy of the optic nerve, not associated with arteritis (NAION).

You should not take VIAGRA with any other drugs for the treatment of erectile dysfunction for oral administration or external use. You should not take VIAGRA if you do not suffer from erectile dysfunction.
Women should not take VIAGRA.
Children and adolescents
Viagra should not be taken by persons under 18 years of age.

Overdose

There is no data for this section.We are currently processing information, please come back later.

Drug interactions

There is no data for this section. We are currently processing information, please come back later.

Form of issue

Viagra is distributed in the form of film-coated tablets.
The tablets are in an aluminum foil blister, which in turn is placed in a cardboard box.

efficacy and side effects ᐉ MC Bogolyuby

Today we will talk about “Viagra” .No, not about the popular group of sexy girls Konstantin Meladze, but about the equally well-known drug for the treatment of erectile dysfunction (impotence).

What is the secret of Viagra?

In its active ingredient, with the hard-to-remember name, sildenafil, which causes relaxation of the smooth muscles of the cavernous bodies of the penis, thereby providing a more consistent and durable erection.

When is Viagra effective?

It is useful in all cases where there is a proven inability of a man to achieve or maintain an erection of the penis sufficient to ensure satisfactory sexual activity.

“Viagra” is available in the form of blue, diamond-shaped tablets with rounded ends, which may contain the active ingredient in doses of 25, 50 or 100 mg.

For the drug to take effect, the man must be sexually stimulated. In the absence of arousal, Viagra is not recommended.

“Viagra” also cannot be considered an aphrodisiac, because, in principle, it does not increase sexual desire, but simply enhances the physiological mechanism of erection, if it has already been caused by an erotic stimulus.

The “Magic” blue pill is usually taken as needed, in doses ranging from 25 to 100 mg one hour before sexual activity, the desired effect will appear within 30-60 minutes. When taken in combination with food, Viagra may have a lagging stimulatory effect. It is not recommended to exceed the dose, and the drug can be taken no more than once a day.

Risks of overdose

A man should know that after drinking a can of Viagra he will not turn into a hot macho, but will provide himself with priapism – a painful erection for 4-6 hours.At the same time, there is a risk of irreversible damage to the corpus cavernosum and irreversible loss of libido.

Under no circumstances should the drug be taken in combination with alcohol or drugs, and in the absence of a real and well-documented problem of erectile dysfunction!

Side effects

The most common side effects associated with the use of this medication include:

• headache;
• redness of the face;
• hot flashes;
• dizziness;
• vision problems;
• light sensitivity;
• nasal congestion;
• indigestion.

Prior medical consultation is recommended to avoid side effects of any kind. Viagra should not be used in combination with nitrates (medicines used to treat angina pectoris), as this can lead to a severe drop in blood pressure, which can lead to shock and sometimes even death.

Viagra is considered safe when prescribed correctly. In fact, there have been many reported deaths after taking the drug in patients at risk for heart disease.Although, it is still not clear whether these deaths can be attributed to the “Viagra” itself or the efforts made during intercourse. Take care of yourself!

90,000 from the first to the current one, with photos, videos and surnames, the old and golden composition of Viagra, news and photos 2020

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Selection of soloists

Since the task was not easy, the work progressed very slowly. The first composition of “Viagra” was recruited for a very long time. The first to get into the group was Alena Vinnitskaya, at that time the TV presenter of the Biz-TV channel, whose general director was Dmitry Kostyuk.He offered a talented and intelligent girl to participate in the project, but she doubted for a long time, as she preferred rock music. The interest to see what would come of this venture prevailed over doubts, and Vinnitskaya agreed.

Numerous auditions did not give results, the producers could not find those who fit the group’s format one hundred percent. The first composition of Viagra – Alena Vinnitskaya and selected girls Marina Kashchin and Yulia Miroshnichenko – began work on the first compositions, but the result did not satisfy Konstantin Meladze and Dmitry Kostyuk, and they decided to close the project.

After some time, they returned to their unfulfilled dream and started all over again, only this time they began to treat the applicants for a place in VIA Gre even more demandingly.

Brief biography of Anastasia Kozhevnikova

Nastya was born in the city of Yuzhnoukrainsk, Nikolaev region, Ukraine. Already at the age of six, she took up vocals and began to sing in the children’s choir “Droplets”. At the age of eight, Nastya went to a music school to learn to play the piano. In parallel with her studies in secondary and music schools, the girl managed to practice choreography and study acting at the pop song theater called “Galatea”.

The childhood dream of becoming an artist of the big stage led Nastya through life. She did not miss a single opportunity to show herself and her talent. The girl took part in all kinds of music competitions, including “The First Swallows”, “Running on the Waves”, “Young Galicia” and others. But she did not achieve much success at that time

The only thing the jury paid attention to was the irrepressible energy of a young girl

When Anastasia turned sixteen, she took part in her first casting on the Superzirka show

But, unfortunately, the girl was again deprived of attention.Nastya did not give up and went to the casting of the “X-Factor” show, where she also did not go beyond the first round

Desperate and abandoning her dream of a big stage, Anastasia became a student at the Kiev National University of Technology and Design. When she found out about the start of the casting of the show “I want to” VIA Gro “, she decided to try her luck for the last time. And this time luck smiled at her – she became a member of the new “Viagra”! The photos that you see in the article demonstrate the girl’s genuine joy! By the age of twenty, she managed to fulfill her first big dream, and this is a real victory!

2004-2009

In order not to take a random person into the team, Konstantin Meladze invited Albina Dzhanabaeva, the backing vocalist of his brother, to the team.However, it was not only a working relationship that connected her with Valery. The mystery of the fatherhood of Dzhanabaeva’s son still haunts journalists. But be that as it may, Dzhanabaeva and Valery Meladze officially announced their relationship much later. In the meantime, a stranger appeared in the group for the role of “redhead”.

Again, one could think about stability, but that was not the case. In 2006, Granovskaya decides to leave VIA Gra – this time she is attracted by the prospects of a TV personality. She is replaced by Christina Kotz-Gottlieb.The girl worked as a model, participated in a beauty contest and could complement the group’s composition with her talents. I could have, but I couldn’t. Christina leaves the group.

She is replaced by Olga Koryagina (Romanovskaya). Having starred in 2 clips, she announces her pregnancy and leaves the ranks of the group. Today she positions herself as a solo performer, shoots videos and releases albums. So, April 2007 VIA Gra meets the loss of another vocalist.

Realizing that three beautiful girls on stage are the most successful form for performances, Meladze invites sultry beauty Meseda Bagaudinova to the group.She managed to stay for 2 years and take part in the recording of several albums. Perhaps Meseda would have been delayed, but Granovskaya again announced her return. She is called the most windy and fickle participant in the project. Meseda leaves, starting a solo career, and Nadia returns. The year 2009 is on the calendar.

But before that, in 2007, Brezhnev managed to leave the project. She also wished to become a solo performer, stating that she was cramped within the framework of the project. Before leaving, Meseda performed a duet with Albina.Although the audience was mixed with the group, the ratings remained high.

Separately, I would like to return to Vera Brezhneva, who left the group in 2007. After leaving the group, she tries herself in several new roles: as a TV presenter, acts in comedy films, gets married and divorces, records songs that have become hits, and surprises everyone by becoming wife of Konstantin Meladze.

By the way, on our website most-beauty.ru there is an interesting article about the most attractive divorced women from the world of show business.

Since Konstantin Meladze is trying in every possible way to preserve the trio format, Tatyana Kotova comes to replace Brezhneva, after a short break since her departure. Beauty, clever, Miss World and Universe contestant – she fascinates the audience with her perfect external data, but in January 2009 she leaves to perform solo. And it seems like an evil fate, haunting the team, which is becoming a kind of a factory of stars.

For a short period the group consists of three soloists Albina Dzhanabaeva, Nadezhda Granovskaya (who replaced Meseda) and Tatyana Kotova (who replaced Vera Brezhneva).

“Golden composition” of sexual “viagra women”

In December 2002, the first member of the team, Alena Vinnitskaya, left the project. She was replaced by a girl from a simple family without a specialized education – Vera Brezhneva. The producers put forward a demand for her – the new participant must change the real Ukrainian name Glushko to a more sonorous, well-known – Brezhnev. After Vinnitskaya left, the main vocal parts remained with Anna Sedokova. She alone could sing professionally, and also had a special education.Nadezhda Granovskaya returned to the roster.

The trio consisting of Nadezhda Granovskaya, Anna Sedakova, Vera Brezhneva was recognized as the “Golden Composition” of the popular VIA-Gra project. The work of the girls called “Do not leave, my love!” for 7 months he occupied the top line in many domestic and foreign charts. In this line-up, the girls went through numerous photo sessions for the covers of famous glossy publications: “MAXIM”, “EGO”, “Play”.

In the middle of spring 2003, the band’s second disc was recorded under the name “Stop Shot!”She deservedly received the “Golden Disc” from the NFPF. This success made it possible to record an English-language album, presented in one of the Moscow shopping and entertainment centers. After that, the girls went on a tour of Israel, where they presented a new track “Goodmorning, Dad!” Later, this song was covered by Israeli singer RoniSuperStar.

In May 2003, the video “Kill my girlfriend” was released, which was filmed in one of the nightclubs in Kiev. Fans of the “VIA-Gra” group wondered why this track was not included in the list of nominees for the “Muz-TV” award.Despite the fact that the clip was broadcast more than fifty times a week, it occupied the top positions of the domestic charts.

In September of the same year, the presentation of the English-language disc “Stop, Stop, Stop!” Took place in Japan. In the first few days, the album sold 30,000 copies. Arriving in Tokyo, the girls were busy 24 hours a day, their day was scheduled by the producers almost in seconds. From the very morning there were numerous interviews with local publications, photo sessions for men’s magazines, performances in clubs.

In November, another disc was presented, called “Biology”. Its release took place at the New Manege, where the VIA-Gra group received the prestigious NFPF prize – “Golden Disc” for their first works “Attempt №5” and “Stop, shot!” In support of the new program, the girls went on tour to the countries of Southeast Asia, and also visited: Belarus, Germany, Israel, Estonia.

Tracks “Don’t Leave Me, Beloved”, “Kill My Friend”, a joint composition with Valery Meladze “Ocean and Three Rivers” made the girls laureates of the “Song of the Year” award.In December 2003, the VIA-Gra group took part in numerous entertainment projects dedicated to the New Year.

Instructions – how to take Viagra

Packaging of the drug Viagra, manufacturer – Pfizer.

Pfizer has developed detailed instructions for the use of Viagra tablets for men.

Basic rules for admission

Viagra tablets are taken orally, no more than once a day in an individually selected dosage 60 minutes before sexual intercourse.The first time the drug is taken with 50 mg, with good tolerance and efficacy (if it sufficiently affects potency), the dose remains the same.

The patient’s body can react differently to the drug. The doctor asks the patient whether the dosage is sufficient to develop a full-fledged erection, after which he can increase or decrease a single dose. Dosage reduction is required by patients with severe liver or kidney damage.

The patient’s age is not taken into account when choosing a dose.

Sometimes, as prescribed by a doctor, it is allowed to drink Viagra while taking such incompatible drugs as riociguat (Adenpas) and ritonavir. In this case, the dose is reduced to 25 mg and the interval between doses is 48 or more hours.

If the patient is constantly taking medications to lower blood pressure, the use of Viagra can be started only under the supervision of a physician after complete normalization of blood pressure, having selected the minimum effective dosage.

Can a healthy man drink pills?

Taking Viagra, you must strictly follow the instructions.

Some healthy men seek to take Viagra to shorten the intervals between sexual intercourse. They are really shrinking. But if a man is healthy and takes sildenafil on his own initiative without a doctor’s prescription, it is dangerous, he may face the following problems:

• with all the listed side effects of the drug;
• with a very long painful erection (priapism), which develops against the background of excessive stimulation of sexual performance, which is very difficult to get rid of.

Alcohol compatibility

It is better not to drink any medicines together with alcohol, as it interferes with their absorption in the stomach and reduces their effectiveness. Alcohol also dilates the arteries and lowers blood pressure – it acts like sildenafil.

The instructions for use indicate that the amount of alcohol taken should be taken into account. So, a dose of Viagra 50 mg does not enhance the vasodilator and blood pressure lowering effect of alcohol, if the level of its content in the blood does not exceed 80 mg / dl.This means that there will be no harm if the man drinks one permissible dose of alcohol – a little beer or wine.

But even if he drinks a small amount of alcohol, which can lead to a decrease in the effectiveness of the drug, taking an additional dose, overdose and an increase in the risk of serious side effects. So everyone decides for himself whether the medicine is compatible with alcohol and whether it is worth using it.

Benefits and harms with long-term use

If there are no contraindications for taking Viagra, it can and is even recommended to be taken for a long time.It was found that when taken for 16 or more weeks, the side effect that bothered the patient in the first days of admission almost completely disappears.

Overdose

Overdose increases the risk of side effects, and they are significant for this drug. Therefore, you should not take risks, Viagra for potency is better to take in the dosage prescribed by your doctor. If, for some reason, 200 mg or more of the medicine was taken, it will be correct to flush the stomach.

How to take Viagra for men correctly and the duration of admission is determined by the doctor.Taking medicine without a doctor’s prescription, independently increasing the dose, combining the intake with other incompatible drugs and large doses of alcohol – this means risking your life and health. Such a technique will not bring benefit, but harm.

Only the correct use of the drug will provide a man with a decent potency.

Nadezhda Granovskaya

If for Alena Vinnitskaya in “VIA Gre” music was the main thing, then the second vocalist Nadya Granovskaya (real name – Meikher) was initially more interested in dance.

“Then I was 18 years old. Alena sang, and I danced on stage. And when I had already worked out the vocals, I began to sing along with other soloists. ”

Having joined the duet in 2000, the girl did not stay there for long. In 2002, she left the team due to pregnancy, and a replacement was quickly found for her. True, the incredible success of the group made Nadezhda return a month after giving birth. Granovskaya sang in VIA Gre until 2006, then left again and returned after three years. In 2011, Nadezhda again left the squad due to a second pregnancy.In between periods of work in this team, the girl was engaged in other areas of her own career.

Television and film work

From 2006 to 2009, the singer hosted the program “Incredible Love Stories” on Ukrainian television. In 2011, she began working in the project The Incredible Truth About the Stars. In 2013, she joined the jury of the reality show “I Want V VIA Gro”.

In 2014, on the Russia 1 channel, Nadezhda Meikher appeared before the viewers of the One-to-One program as Lyudmila Gurchenko.True, this reincarnation was not highly appreciated by the audience. The reason they called the inability of the singer to convey the special energy of the famous artist.

In 2014, Nadezhda also acted as the host of the New Wave program and took part in the NTV project Women’s Things. In 2017, she starred in Oksana Bayrak’s TV series Nothing Happens Twice.

Find out what the Ukrainian singer Andriy Danilko is doing now

Solo career

Inspired by the singing of Maria Callas, Nadezhda decided to study opera singing.She devoted three years to this. She sang “Habanera” – as she herself says, it was a freak number. The singer also performed an aria from “Samson and Delilah” at the fashion show.

Further musical career still lay in the field of stage. In May 2014, the successful single “It’s Not the Body” was released, followed by the compositions “Stay”, “Tango of Return”. In 2017, a new song “I sin – I pray” was presented.

The singer did not limit herself to her own performances, she also decided to act as a producer.Last year, she announced that she started working with young singer Rachelle Dowd.

So, at present the first line-up of “VIA Gra” is mainly engaged in music in various fields.

Poetry and theater

Nadia Meyher also discovered a poet in herself. Back in 2009, a collection of her poetic works “Momentary Attraction” was published. And seven years later, the premiere of her play “Historia de Un Amor”, which included poetry and songs of the author, took place in Kiev.

Creation of designer clothes

She created her own clothing collections under the Meiher by Meiher brand.At first, it was possible to purchase designer items only through the page on Instagram, then in the singer’s boutique.

Personal life

Nadezhda is married to businessman Mikhail Urzhumtsev, the couple have a daughter, Anna, who was born in 2002. The father of the singer’s first child, Igor, is businessman Alexander Lishchenko.

Photo. Nadezhda with her son

Career before VIA Gra

Nadia Meikher was born in 1982 in the small village of Zbruchivka, where she lived until she was four years old.Then the family moved to the regional center Volochisk. The girl was engaged in pop-folk dance. After school, she graduated from the Khmelnytsky Pedagogical School, becoming a musical choreographer. Then the girl began working as a dancer at the Petrovsky Theater. There, in 2000, she met with the famous singer Valery Meladze, who came on tour. Having learned about the casting for a new musical group, Nadezhda quickly ordered a portfolio and sent it to Kiev. She was invited, allowed to listen to “Attempt No. 5” and offered to dance, after which the girl was accepted.

She had to do a lot of vocals, learn to sing and speak without a Ukrainian accent. On the advice of Valery Meladze, the pseudonym Granovskaya was taken. They say that Nadezhda was accepted into the group only because of the presence of a beautiful figure and bright appearance. The singer herself denies this, recalling how long they could not find girls to work with Alena Vinnitskaya.

This is interesting! Of the first line-up of the Lyceum group, only Nastya Makarevich is now engaged in music

Nadezhda Granovskaya in the “Secret for a Million” program:

https: // youtube.com / watch? v = gs-ix68aekE

Scandals

Since the group consisted exclusively of women, they could not avoid a scandalous backstage. If we talk about the first composition, Vinnitskaya claimed that she could not find a common language with Granovskaya. And besides the lack of mutual understanding among themselves, the girls did not feel very good attitude from the leaders. This was expressed in endless tours, travel, studio work and constant pressure. They had to work for many hours at a time, without rest or sleep.

The soloists for the group were selected slender, beautiful and sexy, because of this, their names often surfaced in the yellow press, in the context of this or that provocative news. For example, in 2004, Albina Dzhanabaeva began an affair with then-married Valery Meladze, who lived in two families for 5 years and divorced his wife Irina only in 2009 to marry Dzhanabaeva.

VIA Gra Group and Konstantin Meladze

Konstantin, Valery’s brother, also made headlines in the tabloids.Journalists reported about his affair with young Eva Bushmina, all this happened at the time when Meladze was married to Yana and raised three children with her.

The media wrote that after Tatyana Naynik left the team, a series of terrible events awaited her. The vocalist lost her mother and father, then was beaten in the street, experienced financial difficulties. Former stage colleagues supported her, but this did not save Tanya from prolonged depression. A miracle helped her out of this state – the birth of a child.

Another scandal is associated with the name of Herceg concerning her relationship with Konstantin Meladze. This rumor was also “fueled” by Vera Brezhneva, who removed all photos with her husband from her social network. However, all three involved in this story argue that, apart from the work process, Herceg and Meladze no longer have anything in common.

Action of the drug

Physiological mechanism of erection development.

Normally, the natural physiological mechanism of the development of an erection works like a clock.The process begins with excitement in the cerebral cortex under the influence of any sexual factors (visual, auditory, tactile, olfactory). Excitation is transmitted to the centers of erection of the spinal cord, located in the sacral region, and from there along the nerve endings located in the inner sheath (endothelium) of the cavernous vessels of the penis.

This stimulates the secretion of nitric oxide by endothelial cells. The latter penetrates into cells and stimulates the secretion of cyclic guanosine monophosphate (cGMP), which causes rapid dilatation of small arteries, blood flow to the penis, compression of small veins and impaired blood outflow, leading to the development of a natural physiological response of erection.

In the instructions for Viagra tablets for men, the effect of this drug is described in detail. Sildenafil inhibits the work of phosphodiesterase-5 (PDE-5), causing the release of an additional (about 50%) amount of nitric oxide and cGMP. This contributes to the rapid expansion of small arteries, blood flow, its accumulation in the renis, compression of veins, impaired blood outflow and the development of persistent long-term erection.

The therapeutic effect of Viagra tablets allows for full sexual contact.

The effect of Viagra – pharmacokinetics

After taking the pill inside, it is rapidly absorbed in the intestine and enters the bloodstream and acts on PDE-5, half-suppressing its effect. The effect of the drug is 60 minutes after ingestion. Individually – from 30 to 120 minutes. The speed of absorption can be affected by the consumption of fatty foods.

Decomposition of sildenafil occurs in the liver, while some of the metabolites retain the ability to inhibit PDE-5. The effect of the drug lasts from 4 to 6 hours.

In healthy elderly men, sildenafil is excreted more slowly, which is not a contraindication for prescribing the drug. It is excreted much more slowly in renal failure.

What a man feels

How Viagra works on men, experts have learned from their stories. In most patients, Viagra simply induces an erection that is virtually indistinguishable from a physiological erection an hour after ingestion. But since before that the man had problems with erection, he feels a rise in mood, a feeling of vigor and a surge of masculine strength.

The effect of Viagra on a man is individual. Some, after the first dose, notice a flush of blood to the face, a slight dizziness (it is associated with a decrease in blood pressure). Headaches appear even less often. Sexual intercourse proceeds without misfires.

Uliana Sinetskaya

The future singer was born in Yugorsk on March 29, 1995, but after a while the family moved to Yekaterinburg. From an early age, the girl studied vocals, and at the age of 10 she became a finalist of the Junior Eurovision Song Contest.

Ulyana’s activity can be envied, while still at school, she was awarded the title “Little Vice-Miss World” and the “Golden Cylinder” award.Several times I tried myself in a leading role at festivals.

Years!
1

Therefore, those around her were surprised when the girl entered the Russian Academy of Education and chose psychology as her future profession. Later, the new soloist of “Via Gra” admitted that her whole life was in the song, but she decided that psychology would only help her in what she loved. In parallel with her studies, Ulyana began to work in the pop theater of her hometown.

In 2014, the performance of the song “White Snow” by Vladimir Presnyakov on the television project “Voice-3” brought luck to Ulyana Sinetskaya.The pop master Alexander Gradsky turned to her, under whose leadership the girl continued her further work in this competition, but the young singer did not make it to the final.

After the project, the girl continued to study vocals and even recorded several cover versions of popular songs with Samvel Vardanyan, also a participant in the Voice-3 show, and posted them on YouTube. By the way, during the project, Sinetskaya began an affair with a young man.

In 2017, the show “New Star Factory” was launched, naturally, Ulyana became its participant.Interestingly, Samvel did not lag behind his beloved and was also among the contestants. Thanks to the show, Sinetskaya had a chance to sing with such famous artists as Valery Meladze, Nikita Alekseev, Polina Gagarina and even with “Via Groi”.

Following the results of the reporting concert, a decision was made not in favor of the girl and she had to leave the project. But then, by chance, Philip Kirkorov intervened, Sinetskaya sang his hit “On Love” and the man was delighted with her performance. And although the jury members voted against, the famous singer insisted on his decision, and Ulyana went to the final.

After that, the girl became the soloist of the pop group “CASH”, which made her debut at the gala concert of the “New Star Factory”. But the team soon broke up.

Konstantin Meladze has long drawn attention to the talented girl, and when Anastasia Kozhevnikova got married and announced her desire to build a solo career, he invited Ulyana Sinetskaya to become the new soloist of Via Gra. Now Erica Herceg, Olga Meganskaya and Ulyana Sinetskaya are singing as part of the group.

selections

Army PesniKlassika pianinoMuzyka of reklamyDetskie songs from multfilmovMuzyka for aerobikiSbornik songs 70s godovDlya favorite chelovekaKlassika in modern obrabotkeKlubnye mixes Russian ispolniteley3D ZvukDalnoboyschikiZarubezhny rap for mashinyTopovye Club TrekiMoschnye BasyDiskoteka 2000Pesni about papuHristianskie PesniZimnyaya MuzykaMuzyka For MeditatsiiRusskie Hits 90HGrustnaya MuzykaRomantic SaxophoneTantsevalny hip hopNovogodnie pesniZarubezhnye hits 80 – 90Pesni about pokemonaRomanticheskaya MuzykaMotivatsiya for workoutsMusic for sexMusic for carMusic for strength trainingGrammy 2017

Short biography of Erica Herceg

Erica was born in a village called Malaya Dobran, which is located near the border of Ukraine with Hungary, near Uzhgorod.

The girl has mixed blood: her father is Hungarian, mother is the daughter of a Ukrainian and a Hungarian. Erica’s parents got married when they were very young – dad was 22, mom – 18. When the girl was five years old, the family decided to have a second child. The birth was very difficult, which adversely affected the health of Erica’s mother. Concern for the well-being of the family and the upbringing of young children completely fell on the shoulders of Nikolai, the father of the family. Erika went to a Hungarian school, where she studied Ukrainian for only two hours a week.Every day for this she went 12 kilometers from home and crossed the border. When the rules for crossing the borders of countries became stricter, the girl had to change school.

In high school, Erica studied at the lyceum at the local church, sang in the church choir.

After receiving a certificate of secondary education, the girl went to the city of Beregovo in order to become a student at the Ferenc Rakozzi II Transcarpathian Hungarian Institute. During her studies, Erica worked as a waitress at a local cafe.

2008 was a year of change for the girl. She lost as much as 30 kilograms in order to try her hand at modeling. She starred in advertisements for jewelry and lingerie.

Work in a modeling agency in 2011 brought the girl to Kiev. There, in 2012, she received her first major contract with a French lingerie company. In the same year she was invited to appear in one of the autumn issues of Playboy magazine. And in 2013, she was already included in the new composition of “Viagra”.At the age of 25, Erica achieves real success.

2002-2003 – Trio format

After the departure of Nainik, VIA Gra acquired the classic appearance of a trio-ensemble, which included a blonde, a brunette and a redhead. But it seemed to everyone that this is constancy, Alena Vinnitskaya, who stood at the origins of the foundation, announced her desire to leave the group. The girl announced her intention to start a solo project. By the way, she coped with the task, having released 8 albums, filming 20 clips.He successfully combines active creative life with family life. Her husband is Sergey Alekseev, who is also her producer.

Realizing that the trio is the most successful form of the collective, Meladze urgently began to look for a replacement for Vinnitskaya, who had left the project. She was replaced by Vera Brezhneva. Music critics still call this line-up “golden”. The girls received the first prize on Muz TV, duets with Valery Meladze were recorded. But stability and group composition are incompatible concepts. It would seem at the peak of fame, when everything is fine – Anna Sedokova suddenly thought about her personal life.The red-haired woman decided to leave the participants in 2004, having traded the show business routine for the role of the footballer’s wife and mother for her daughter. However, for a long time to be away from the stage, she did not succeed and she returned to the stage as a solo performer. Today she combines the role of a singer with the role of a mother of many children, produces clothes under her own brand and successfully tours in America.

Sedokova’s departure forced Meladze to look for a replacement again, this time with the “redhead”. So, Svetlana Loboda appeared in the team (at that time her hair was dyed red).

True to the audience of fans, for some reason she did not like it, and she did not make friends with the girls either. The contract was terminated after 4 months. But Svetlana did not take the failure to heart, on the contrary, it became an impetus and incentive for her to build a solo career and an active social life. She becomes a clothing designer (it is very fashionable among the stars), starred in television projects, received the title of People’s Artist of Ukraine and is actively touring.

List of sources

90,000 Residents of WKO are asking to take an active part in the population census

The Department of Statistics for the WKO complains that residents do not always open their doors or simply refuse to give interviews.

Illustrative photo from MG archive

Population census in Kazakhstan takes place every 10 years. The main phase of the 2021 national census runs from September 1 to October 30.

Meanwhile, the Bureau of the Department of Statistics for WKO reported that residents of the region do not always meet the census staff halfway.

– We encourage everyone to take an active part in the population census, as this campaign will affect the improvement of the quality of life of citizens.Each of you must understand the full responsibility and importance of this campaign. The population census is the only tool that allows you to create a unified portrait of the country. You are the source of information. Conducting the next census in the country will fully analyze the demographic and socio-economic situation in the country and improve the quality of life of citizens, ”the statistics department addressed to the residents of WKO. – There is not much time left until the completion of the census, but the census personnel have to face difficulties in their work every day.At times, some residents won’t open doors, don’t give out online census notification numbers, or simply refuse to be interviewed.
We urge every inhabitant of our region to pass the census either online or to use the services of the census personnel! You can take the census online through the specialized site sanaq.gov.kz.

To date, according to the Bureau of National Statistics, almost 91.6 percent of the population of Kazakhstan or 17 428 058 people took part in the national population census.At the same time, 40.4% passed it in the online format, 51.2% – in the offline format.

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