What is Nitro-Bid ointment used for. How does nitroglycerin ointment work for angina. What are the potential side effects of Nitro-Bid. How to properly apply nitroglycerin ointment. When should you not use Nitro-Bid.

Understanding Nitro-Bid: A Powerful Nitroglycerin Ointment for Angina Management

Nitro-Bid is a brand name for nitroglycerin ointment, a topical medication used primarily in the treatment and prevention of angina pectoris. This 2% ointment formulation delivers nitroglycerin through the skin, offering a unique approach to managing chest pain associated with coronary artery disease.

Key Features of Nitro-Bid:

• Active Ingredient: Nitroglycerin 2%
• Formulation: Topical ointment
• Typical Package Size: 30 gm tube
• Manufacturer: Savage Laboratories
• Prescription Required: Yes

Nitro-Bid’s unique delivery system allows for sustained release of nitroglycerin, providing longer-lasting relief compared to sublingual tablets or sprays. This makes it particularly useful for preventing angina episodes, especially during activities known to trigger chest pain.

How Does Nitro-Bid Work to Alleviate Angina Symptoms?

Nitroglycerin, the active component in Nitro-Bid, belongs to a class of drugs called nitrates. These medications work by relaxing and widening blood vessels throughout the body, including those supplying the heart muscle.

Mechanism of Action:

1. Vasodilation: Nitroglycerin causes smooth muscle relaxation in blood vessels, leading to their dilation.
2. Improved Blood Flow: Widened blood vessels allow for increased blood flow to the heart muscle.
3. Reduced Workload: By decreasing preload and afterload on the heart, nitroglycerin reduces the heart’s oxygen demand.
4. Pain Relief: Improved oxygen supply to the heart muscle helps alleviate angina pain.

Is Nitro-Bid effective for all types of angina? While Nitro-Bid is particularly useful for stable angina, it may not be as effective for variant (Prinzmetal’s) angina or unstable angina. These conditions often require different treatment approaches, and a healthcare provider should be consulted for proper management.

Proper Application and Dosage Guidelines for Nitro-Bid Ointment

Correct application of Nitro-Bid is crucial for achieving optimal therapeutic effects while minimizing the risk of side effects. Always follow your healthcare provider’s instructions and the guidelines provided with the medication.

General Application Instructions:

• Clean and dry the application area before use.
• Apply the prescribed amount of ointment to the skin, typically on the chest, arms, or back.
• Use the enclosed measuring applicator to ensure accurate dosing.
• Spread the ointment over a 2-3 inch area without rubbing it in completely.
• Cover the application site with provided plastic wrap to enhance absorption.
• Wash hands thoroughly after application to avoid unintended exposure.

How much Nitro-Bid should be applied, and how often? The typical starting dose is ½ inch (1.3 cm) of ointment applied every 8 hours. However, dosage may vary based on individual patient needs and response to treatment. Your healthcare provider will determine the appropriate dosage and frequency for your specific condition.

Potential Side Effects and Precautions When Using Nitro-Bid

While Nitro-Bid can be highly effective in managing angina, it’s important to be aware of potential side effects and take necessary precautions.

Common Side Effects:

• Headache
• Dizziness
• Lightheadedness
• Flushing
• Skin irritation at the application site

Can Nitro-Bid cause serious side effects? In rare cases, more severe side effects may occur, including:

• Severe hypotension (low blood pressure)
• Syncope (fainting)
• Allergic reactions
• Methemoglobinemia (a blood disorder)

If you experience any severe or persistent side effects, seek medical attention immediately.

Precautions and Contraindications:

• Do not use Nitro-Bid if you’re taking medications for erectile dysfunction, such as sildenafil, tadalafil, or vardenafil.
• Avoid alcohol while using nitroglycerin ointment, as it can enhance the blood pressure-lowering effects.
• Inform your healthcare provider of all medications you’re taking, including over-the-counter drugs and supplements.
• Use caution when operating machinery or driving, as dizziness and lightheadedness may occur.

Nitro-Bid vs. Other Forms of Nitroglycerin: Comparing Efficacy and Usage

Nitroglycerin is available in various formulations, each with its own advantages and specific use cases. Understanding these differences can help patients and healthcare providers choose the most appropriate option for managing angina.

Comparison of Nitroglycerin Formulations:

Why might a healthcare provider choose Nitro-Bid over other nitroglycerin formulations? Nitro-Bid offers several advantages:

• Longer duration of action compared to sublingual tablets or sprays
• Ability to tailor dosage more precisely
• Reduced risk of systemic side effects due to slower absorption
• Useful for preventing predictable angina episodes, such as those triggered by exercise

However, Nitro-Bid is not suitable for rapid relief of acute angina attacks due to its slower onset of action. In such cases, sublingual nitroglycerin remains the preferred option.

Storage and Handling: Ensuring Nitro-Bid’s Effectiveness and Safety

Proper storage and handling of Nitro-Bid are essential to maintain its effectiveness and ensure safe use. Nitroglycerin is a sensitive compound that can degrade if not stored correctly.

Storage Guidelines:

• Keep Nitro-Bid at room temperature, between 68°F to 77°F (20°C to 25°C).
• Avoid exposure to heat, moisture, and direct light.
• Do not refrigerate or freeze the ointment.
• Keep the tube tightly closed when not in use.
• Store away from children and pets.

How long can Nitro-Bid be stored before it expires? Typically, Nitro-Bid has a shelf life of about 2 years from the date of manufacture. Always check the expiration date on the package and discard any unused medication after this date.

Handling Precautions:

• Always wash hands before and after handling the ointment.
• Use the provided applicator to measure the correct dose.
• Avoid touching the tip of the tube to any surface to prevent contamination.
• Do not share your Nitro-Bid with others, even if they have the same condition.

Can Nitro-Bid be dangerous if mishandled? While nitroglycerin ointment is generally safe when used as directed, it can be harmful if ingested or if excessive amounts are absorbed through the skin. Keep it out of reach of children and pets, and seek immediate medical attention in case of accidental ingestion.

Nitro-Bid in Combination Therapy: Enhancing Angina Management

While Nitro-Bid can be effective on its own for many patients with stable angina, it is often used as part of a comprehensive treatment plan. Combination therapy can provide more robust angina control and address multiple aspects of coronary artery disease.

Common Medications Used in Conjunction with Nitro-Bid:

• Beta-blockers: Reduce heart rate and blood pressure, decreasing the heart’s workload.
• Calcium channel blockers: Relax blood vessels and reduce the heart’s workload.
• Aspirin: Helps prevent blood clots that can cause heart attacks.
• Statins: Lower cholesterol levels to slow the progression of atherosclerosis.
• ACE inhibitors: Improve blood flow and reduce strain on the heart.

How does combining Nitro-Bid with other medications improve angina management? By targeting different aspects of cardiovascular function, combination therapy can:

• Provide more comprehensive symptom relief
• Reduce the frequency and severity of angina attacks
• Improve overall cardiovascular health
• Potentially slow the progression of coronary artery disease

It’s crucial to note that medication combinations should only be used under the guidance of a healthcare provider, as some drug interactions can be dangerous or reduce effectiveness.

Monitoring and Follow-up: Ensuring Optimal Results with Nitro-Bid Treatment

Regular monitoring and follow-up are essential components of successful angina management with Nitro-Bid. These practices help ensure the medication’s effectiveness, detect any adverse effects early, and allow for timely adjustments to the treatment plan.

Key Aspects of Monitoring:

• Symptom tracking: Keep a log of angina episodes, including frequency, duration, and triggers.
• Blood pressure monitoring: Regular checks help assess the medication’s effects on cardiovascular function.
• Periodic blood tests: May be required to monitor for potential side effects or complications.
• Electrocardiograms (ECGs): Help evaluate the heart’s electrical activity and detect any changes.
• Stress tests: Assess the heart’s response to physical exertion and the effectiveness of the treatment.

How often should patients using Nitro-Bid have follow-up appointments? The frequency of follow-up visits can vary based on individual needs and the stability of the condition. Typically, patients might have:

• Initial follow-up within 2-4 weeks of starting treatment
• Regular check-ups every 3-6 months if the condition is stable
• More frequent visits if symptoms are not well-controlled or if medication adjustments are needed

During these appointments, healthcare providers can assess the treatment’s effectiveness, address any concerns, and make necessary adjustments to the care plan.

Signs That May Indicate a Need for Treatment Adjustment:

• Increasing frequency or severity of angina episodes
• Development of new symptoms or side effects
• Changes in the pattern of angina attacks
• Difficulty adhering to the prescribed treatment regimen

What should patients do if they experience worsening symptoms despite using Nitro-Bid? If angina symptoms worsen or become more frequent, patients should:

• Contact their healthcare provider promptly
• Not adjust the medication dosage on their own
• Be prepared to seek emergency medical care if symptoms are severe or prolonged

Remember, effective angina management is a collaborative effort between patients and healthcare providers. Open communication and adherence to the treatment plan are crucial for achieving optimal results with Nitro-Bid therapy.

Nitro-Bid (Brand for Nitroglycerin, Topical Ointment)

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Nitro-Bid®, (Nitroglycerin Ointment USP 2%), 2%, Ointment, 30gm Tube

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  Nitro-Bid®, (Nitroglycerin Ointment USP 2%), 2%, Ointment, 30gm Tube
  
  

Manufacturer:

Savage

$55. 37

Item Code:
003922

Mfg Part #:
00281-0326-30

Controlled:

—Yes

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Products specifications

Brand Name	Nitro-Bid®
Medical License Required	Yes
Container	Tube
Feature	Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate
Form	Ointment
Generic Name	Nitroglycerin Ointment
Route of Administration	Topical
Size	30 gm
Strength	0. 02
Therapeutic Class	Diuretic/Cardiovascular
Unit of Measure	Each

Products specifications

Brand Name	Nitro-Bid®
Medical License Required	Yes
Container	Tube
Feature	Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate
Form	Ointment
Generic Name	Nitroglycerin Ointment
Route of Administration	Topical
Size	30 gm
Strength	0. 02
Therapeutic Class	Diuretic/Cardiovascular
Unit of Measure	Each

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Duagra 100 mg/60 mg No. 4 tablets

According to foreign studies, most men believe that there are 2 main requirements,

necessary for good sex:

1. hard erection (excitation of the penis)

2. prolonged sexual intercourse

It is important to understand that a good erection and sufficient duration of sexual contact is not only a condition for a woman to enjoy, but also the basis of a man’s self-confidence!

Sildenafil-based preparations have proven themselves well for weak erections. This substance really significantly enhances erection, but, unfortunately, does not affect the duration of sexual intercourse. As a result, those men who ejaculate too early, namely in the first 2 minutes after the start of sexual intercourse, will also finish sex without satisfying expectations, even despite a good, strong erection.

Duagra is a modern solution to this problem!

Duagra contains 2 components at once:

1. Sildenafil 100 mg – to increase erection

2. Dapoxetine 60 mg – to increase the time of sexual intercourse

Thanks to this, Duagra gives a double effect – it creates a firm erection of the penis and, what is important, prolongs the duration of sexual intercourse several times!

If you have problems with erection and premature termination of sexual intercourse, take Duagra in the usual dose – 1 tablet, 1 time per day; or half a tablet, but not more than 1 whole tablet within 24 hours.

Take Duagra at least 1 hour before planned sexual activity. It is advisable to take the drug on an empty stomach, as food slows down the speed of the onset of the effect. If necessary, you can eat 30-40 minutes after taking the pill.

Be sure to remember that if you are receiving any medications as a treatment, then taking Duagra is possible only after consulting with your doctor.

Preparations containing sildenafil must not be used if you are taking nitroglycerin, isosorbide dinitrate or isosorbide mononitrate!

Do not drink alcohol while taking Duagra. For more information, read the instructions for the drug.

Before use, consult your doctor and check for possible contraindications.

Dosage form

Film-coated tablets

Composition

Each film-coated tablet contains:

Pharmacotherapeutic group

Preparations for the treatment of urological diseases. Other drugs for the treatment of urological diseases, including antispasmodics. Other drugs for the treatment of urological diseases. Preparations for the treatment of erectile dysfunction. Combinations.

ATC code G04BE30

Pharmacological properties

Pharmacodynamics

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

Dapoxetine is a short-acting drug for the treatment of premature ejaculation in men.

Mechanism of action

The physiological mechanism responsible for penile erection involves the release of nitric oxide (NO) in the cavernous body during sexual stimulation. Nitric oxide then activates the enzyme guanylate cyclase, which leads to an increase in cyclic guanosine monophosphate (cGMP), causing smooth muscle relaxation in the cavernous body and allowing blood flow.

Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI) with an IC501.12nM, while its main human metabolites, desmethyldapoxetine (IC50<1.0nM) and didesmethyldapoxetine (IC50=2.0nM) are equivalent or less effective (dapoxetine -N-oxide) (IC50=282 nM)).

It is assumed that the mechanism of action of dapoxetine in premature ejaculation is associated with inhibition of the reuptake of serotonin by neurons and a subsequent increase in the action of the neurotransmitter on pre- and postsynaptic receptors.

Pharmacokinetics

Sildenafil

Absorption

Silden afil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30-120 minutes (mean 60 minutes) when taken orally in the fasted state. The mean absolute oral bioavailability is 41% (range 25-63%). After oral administration of Sildenafil, AUC and Cmax increase in proportion to the dose in the recommended dose range (25-100 mg).

When Sildenafil is taken with food, the rate of absorption decreases with an average delay tmax60 minutes and an average decrease in Cmax29%.

Distribution:

The mean volume of distribution (Vd) at steady state for sildenafil is 105 L, which indicates tissue distribution. After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/mL (CV40%). Since sildenafil (and its main circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this leads to the fact that the average maximum free plasma concentration for sildenafil is 18 ng / ml (38 nM). Protein binding does not depend on the total concentration of the drug.

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

Biotransformation:

Sildenafil is cleaved predominantly by liver isoenzymes CYP3A4 microsomes (main pathway) and CYP2C9(main path). The main circulating metabolite is the result of N-demethylation of sildenafil. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% higher than the parent drug. Plasma concentrations of this metabolite are approximately 40% of those observed for sildenafil. The N-desmethyl metabolite is further metabolized with a final half-life of approximately 4 hours.

Remedy:

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

DAPRESTITYDROCHLORID

The absorption:

Doplisetine is fastened with maximum plasma concentrations (CMAX), which occur after 1-2 hours of the tablet after the tablet. Absolute bioavailability is 42% (range 15-76%), and a proportional increase in dose (AUC and Cmax) is observed at a dose of 30-60 mg. After multiple doses, AUC values ​​for both dapoxetine and the active metabolite desmethyldapoxetine (DED) increase by approximately 50% compared to single dose AUC values.

A high-fat meal slightly decreased the Cmax (by 10%) and modestly increased the AUC (by 12%) of dapoxetine and slightly delayed the time to peak dapoxetine concentrations. These changes are not clinically significant. Dapoxetine can be taken with or without food.

Allocation:

Over 99% of dapoxetine is bound in vitro to human serum proteins. The active metabolite desmethyldapoxetine (DED) is 98.5% protein bound. Dapoxetine has an average stationary volume of distribution of 162 liters.

Biotransformation:

Test tube studies show that dapoxetine is cleared from several enzyme systems in the liver and kidneys, primarily CYP2D6, CYP3A4 and flavin monooxygenase (FMO1). several metabolites, mainly through the following biotransformation pathways: N -oxidation, N-demethylation, naphthylhydroxylation, glucuronidation and sulfation. There were signs of first pass first pass metabolism after oral administration.

Intact dapoxetine and dapoxetine-N-oxide were the main circulating components in plasma. In vitro binding and transport studies indicate that dapoxetine-N-oxide is inactive. Additional metabolites, including desmethyl-dapoxetine and didesmethyl-dapoxetine, account for less than 3% of total circulating drug-related substances. 5.1). The unrelated effects (AUC and Cmax) of DED are approximately 50% and 23%, respectively, of the unrelated effects of dapoxetine.

Elimination:

Dapoxetine metabolites are mainly excreted in the urine as conjugates. The unchanged active substance was not detected in the urine. Following oral administration, dapoxetine has an initial half-life (utilization) of approximately 1.5 hours, with plasma levels less than 5% of peak concentrations 24 hours post-dose, and a terminal half-life of approximately 19 hours. The terminal half-life of DED is approximately 19 hours.

Indications for use

– treatment of erectile dysfunction in men characterized by an inability to achieve and maintain an erection of the penis sufficient for satisfactory intercourse

– intravaginal ejaculation latent time (IELT) less than two minutes

– persistent or re-ejaculation after minimal sexual stimulation before, during time, or shortly after sexual penetration, and earlier than desired by the patient

– severe stress or difficulties arising in interpersonal relationships as a consequence of PE

– insufficient control over the onset of ejaculation

Method of administration and dosage at least one full glass of water.

Do not exceed 1 tablet in 24 hours.

Adult use:

The recommended dose is 50 mg for sildenafil and 30 mg for dapoxetine and can be taken as needed – about an hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100 mg sildenafil and 60 mg dapoxetine.

The maximum recommended dose is 100 mg for sildenafil and 60 mg for dapoxetine.

The maximum recommended dosing frequency is once a day

How to use

Take orally with a glass of water. Should be taken 1-2 hours before sexual activity. Take once daily as needed 1-3 hours before sexual activity. Do not take more than once a day.

Drug interactions

Nitrates

Concomitant use of sildenafil citrate with nitrates in any form is contraindicated.

Peritoneal and other potent CYP3A inhibitors

Concomitant use of sildenafil citrate with peritoneal or other potent CYP3A inhibitors is not recommended.

Alpha-blockers

Use caution when prescribing alpha-blockers concomitantly with sildenafilz and trate due to the additional hypotensive effect.

Amlodipine

When sildenafil citrate 100 mg was given simultaneously with amphetamine, 5 mg or 10 mg orally, to hypertensive patients, the mean additional reduction in blood pressure in the supine position was 8 mm Hg systolic and 7 mm Hg diastolic.

Potential for interaction with monoamine oxidase inhibitors

Dapoxetine should not be used in combination with an MAOI, or within 14 days of stopping the MAOI. Similarly, MAOIs should not be administered within 7 days of discontinuing dapoxetine.

Interaction potential with thioridazine

Thioridazine should not be administered within 14 days of stopping dapoxetine.

Serotonergic drugs/herbal products

Dapoxetine should not be used concomitantly with other SSRIs, MAOIs, other drugs/herbal products or within 14 days of discontinuation of these drugs/herbal products. Likewise, these drugs should not be administered within 7 days of discontinuing dapoxetine treatment.

Medicinal products acting on the central nervous system

Caution must be exercised if concomitant use of dapoxetine with such medicinal products is required.

Effect of concomitantly administered drugs on dapoxetine hydrochloride

In vitro studies in hepatic, renal, intestinal microsomes show that dapoxetine is metabolized predominantly by CYP2D6, CYP3A4 and flavin monooxygenase 1 (FMO1). Thus, inhibitors of these enzymes may reduce clearance of dapoxetine.

CYP 3 A 4 inhibitors aquinavir, telithromycin, nefazodone, nelfinavir and atazanavir are contraindicated.

CYP 2 D 6 inhibitors with a weak metabolism of CYP2D6.

Special instructions

Sexual activity poses a risk to the heart in patients with cardiovascular disease. Sildenafil citrate in general should not be used in people for whom sexual activity is not recommended due to the condition of their cardiovascular system. Prior to prescribing sildenafil, the physician should carefully consider the possibility that the patient may be adversely affected by such vasodilating effects, especially in combination with sexual activity.

Caution is advised when prescribing phosphodiesterase type 5 (PDE5) inhibitors concomitantly with alpha-blockers. PDE5 inhibitors, including Viagra (sildenafil citrate) and alpha-adrenaline blockers, are both vasodilators that have blood pressure lowering effects. When used in combination with vasodilators, an additional effect on BP can be expected. In some patients, the concurrent use of both drugs can significantly reduce BP, and lead to symptomatic hypotension. Sildenafilcitrate has a systemic vasodilating effect and may enhance the blood pressure-lowering effect of other antihypertensive drugs. Sildenafil citrate should be used with caution in patients with an anatomical deformity of the penis (such as strangulation, cavernous fibrosis, and Clapeyronie’s disease) or in patients with conditions that may be predisposing factors for priapism (such as sickle cell anemia, myeloma, or leukemia).

The safety and efficacy of combinations of Viagra (sildenafil citrate) with other treatments for erectile dysfunction have not been studied. Thus, the use of such combinations is not recommended.

Ethanol

Combining alcohol with dapoxetine may enhance alcohol-related precognitive effects and may also increase the frequency of adverse effects on the cardiogram, such as syncope, thereby increasing the risk of accidental injury; thus, patients are advised to avoid the consumption of alcoholic beverages while taking dapoxetine.

Syncope

Dapoxetine should be used with caution in patients taking drugs with vasodilating properties (eg, alpha-adrenaline receptor antagonists, nitrates, PDE5 inhibitors) due to possible decreased thermostatic tolerance.

Moderate inhibitors CYP 3 A 4

Caution is advised in patients taking moderate CYP3A4 inhibitors and dose is limited and up to 30 mg.

Potent CYP2D6 inhibitors

Caution is advised if increasing the dose to 60 mg in patients taking potent CYP2D6 inhibitors or if increasing the dose to 60 mg in patients with poor CYP2D6 metabolism, as this may increase exposure levels, which may lead to a higher incidence and severity of adverse reactions depending from dosage.

Suicide/suicidal ideation

Antidepressants, including SSRIs, have been shown to increase the risk of suicidal ideation and suicide compared with placebo in short-term studies in children and adolescents with major depressive disorder and other psychiatric disorders.

Mania

Dapoxetine should not be used in patients with a history of mania/hypomania or bipolar disorders and should be discontinued in any patient with symptoms of these disorders. Seizures: Due to the potential of SSRIs to lower the seizure threshold, dapoxetine should be discontinued in a patient who develops seizures and should be avoided in patients with unstable epilepsy. Patients with controlled epilepsy should be closely monitored.

Use in children and adolescents under 18 years of age: Dapoxetine is not intended for use in children under 18 years of age.

Depression and psychiatric disorders

Men with signs and symptoms of depression should be screened prior to prescribing dapoxetine to rule out depressive disorders. Concurrent treatment with dapoxetine and antidepressants, including SSRIs and Spris, is contraindicated. Physicians should warn patients to report all disturbing thoughts and feelings at all times, and if symptoms of depression appear during treatment, treatment with dapoxetine should be discontinued.

Renal impairment

Dapoxetine is not recommended in patients with cardiac impairment of renal function and caution is advised in patients with mild or moderate renal impairment.

Lactose intolerance

Patients with a rare hereditary disease of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this drug.

CYP 3 A 4 inhibitors

CYP3A4 inhibitors such as ketoconazole, itraconazole, yarrow, streptomycin, nefarious, Scandinavia, and atavistic are contraindicated.

Moderate CYP 3 A 4 inhibitors CYP3A4 inhibitor.

PDE 5 inhibitors

Dapoxetine should be used with caution in patients using PDE5 inhibitors due to possible reduced thermostatic tolerance.

Tuberculosis

Dapoxetine should be used with caution in patients using alpha-blocker receptor antagonists due to a possible decrease in thermostatic tolerance.

Warfarin

No data available to assess the effect of chronic use of warfarin with dapoxetine; thus, caution should be exercised when administering dapoxetine to patients who are chronically taking warfarin.

Pregnancy and lactation

Contraindicated for pregnant women and during lactation. Animal studies do not demonstrate a direct or indirect negative effect on fertility, pregnancy, embryonic-fetal development. It is not known whether the substance is excreted in breast milk.

Overdose

No cases of overdose have been reported. In case of overdose, standard supportive measures should be applied, if necessary. Due to the high degree of protein binding and large volume of distribution, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be effective. The specific antidote is not known.

Side effects

Often

• headache, dizziness
• chromatopsia (mild and transient, mainly color perception changes), visual impairment

90 007 nasal congestion

• dyspepsia
• congestion

Rarely

• myocardial infarction, atrial fibrillation
• acute cerebrovascular accident, syncope
• deafness
• epistaxis
• hypertension, hypotension
• hypersensitivity reactions
• convulsions, recurrent convulsions

Very rare

• tachy cardia
• drowsiness, decreased sensation
• conjunctival disorders and other eye diseases
• tinnitus
• nausea, vomiting, dry mouth
• skin rash,
• muscle pain
• chest pain, fatigue

Unknown

• ventricular arrhythmia, unstable angina pectoris, sudden death teritic ischemic optic neuropathy, retinal vascular occlusion
• priapism, prolonged erection

Contraindications

• hypersensitivity to the active substance or components of the drug
• patients in whom sexual activity is not recommended (for example, with unstable angina or severe heart failure)
• patients with loss of vision in one eye due to anterior non-arteritic ischemic optic neuropathy
• severe liver failure
• patients with rare consequent problems of galactose intolerance, stylactase deficiency, or glucose-galactose malabsorption
• use in combination with nitrates or nitric oxide donors
• not intended for use in women
• children and adolescents under 18 years of age

caution at :

• anatomical deformity of the penis (including angulation, cavernous fibrosis or Peyronie’s disease)
• diseases predisposing to the development of priapism (such as sickle cell anemia, multiple myeloma, leukemia, thrombocythemia)
• diseases accompanied by bleeding
• exacerbation of peptic ulcer
• hereditary retinitis pigmentosa
• heart failure,
• unstable angina, myocardial infarction, stroke or life-threatening arrhythmias in the last 6 months

arterial hypertension (blood pressure (BP) > 170/100 mm Hg Hg) or hypotension (BP < 90/50 mmHg)

Storage conditions

Store below 30ºC in a dry place.