Tamsulosin Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

Tamsulosin is used by men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It does not shrink the prostate, but it works by relaxing the muscles in the prostate and the bladder. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night).Tamsulosin belongs to a class of drugs known as alpha blockers.Do not use this medication to treat high blood pressure.

How to use Tamsulosin HCL

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily, 30 minutes after the same meal each day. Swallow this medication whole. Do not crush, chew, or open the capsules.

The dosage is based on your medical condition and response to treatment.

Tamsulosin may cause a sudden drop in your blood pressure, which could lead to dizziness or fainting. This risk is higher when you first start taking this drug, after your doctor increases your dose, or if you restart treatment after you stop taking it. During these times, avoid situations where you may be injured if you faint.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you have not taken this drug for several days, contact your doctor to see if you need to be restarted at a lower dose.

It may take up to 4 weeks before your symptoms improve. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Dizziness, lightheadedness, drowsiness, runny/stuffy nose, or ejaculation problems may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking tamsulosin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, certain eye problems (cataracts, glaucoma).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery (including cataract/glaucoma eye surgery), tell your doctor or dentist if you are taking or have ever taken this medication, and about all the other products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness and low blood pressure when getting up from a sitting or lying position. These side effects can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: other alpha blocker drugs (such as prazosin, terazosin).

If you are also taking a drug to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may need to adjust your medications to minimize this risk.

Other medications can affect the removal of tamsulosin from your body, which may affect how tamsulosin works. Examples include azole antifungals (such as itraconazole, ketoconazole), clarithromycin, cobicistat, HIV protease inhibitors (such as lopinavir), mifepristone, ribociclib, ritonavir, among others.

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting.

Do not share this medication with others.

Lab and/or medical tests (such as prostate exams, blood pressure) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

tamsulosin 0.4 mg capsule

Color: olive green,orangeShape: oblongImprint: D 53

This medicine is a olive green orange, oblong, capsule imprinted with “D” and “53”.

tamsulosin 0.4 mg capsule

Color: peach,greenShape: oblongImprint: ZA-18 0.4mg

This medicine is a olive green orange, oblong, capsule imprinted with “D” and “53”.

tamsulosin 0.4 mg capsule

Color: olive green,orangeShape: oblongImprint: TAM 0.4 mg

This medicine is a olive green orange, oblong, capsule imprinted with “D” and “53”.

tamsulosin 0.4 mg capsule

Color: olive green,light yellowShape: oblongImprint: 160 160

This medicine is a olive green orange, oblong, capsule imprinted with “D” and “53”.

tamsulosin 0.4 mg capsule

Color: olive green,orangeShape: oblongImprint: W 516

This medicine is a olive green orange, oblong, capsule imprinted with “D” and “53”.

tamsulosin 0. 4 mg capsule

Color: olive green,orangeShape: oblongImprint: CL 23 0.4

This medicine is a olive green orange, oblong, capsule imprinted with “D” and “53”.

tamsulosin 0.4 mg capsule

Color: blueShape: oblongImprint: MYLAN 2500 MYLAN 2500

This medicine is a olive green orange, oblong, capsule imprinted with “D” and “53”.

tamsulosin 0.4 mg capsule

Color: light green,yellowShape: oblongImprint: TML 0.4 TML 0.4

This medicine is a olive green orange, oblong, capsule imprinted with “D” and “53”.

tamsulosin 0.4 mg capsule

Color: olive green,orangeShape: oblongImprint: TSL 0.4

This medicine is a olive green orange, oblong, capsule imprinted with “D” and “53”.

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Drug Survey

Are you currently using Tamsulosin HCL?

This survey is being conducted by the WebMD marketing sciences department.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Tamsulosin Side Effects: Things to Consider

1. What is tamsulosin?
2. Tamsulosin side effects
3. Tamsulosin side effects in elderly people
4. Tamsulosin side effects long term
5. Flomax side effects after stopping

If you’ve been prescribed tamsulosin (brand name Flomax) for benign prostatic hyperplasia (BPH), you might want to know more about potential tamsulosin side effects. Although studies show that tamsulosin is a safe and effective medication, all drugs can have the potential for adverse effects. Some tamsulosin side effects include dizziness, headaches, priapism, low blood pressure, and more. Continue reading to learn more about the medication. 

Tamsulosin (brand name Flomax) is part of a class of medications known as alpha-blockers (α-blockers). The medication is FDA-approved to treat benign prostatic hyperplasia (BPH), also known as an enlarged prostate. This is a common condition that affects about half of all men between the ages of 51 and 60 and over 70% of men older than 60.

The prostate gland is located at the base of the bladder and surrounds the ureter (the tube that carries urine from the bladder out of the body via the penis). As the prostate gets larger, it can put pressure on the urethra, leading to lower urinary tract symptoms (LUTS). A classic symptom of BPH is needing to pee more often, especially at night. 

Other symptoms of BPH include difficulty starting urination, weak urine flow, straining when urinating, and starting/stopping frequently during urination. Tamsulosin helps relax the muscles of the prostate and bladder. This can allow the urethra to expand and improve the flow of urine, alleviating urinary symptoms caused by an enlarged prostate. 

Other examples of alpha blockers include prazosin (brand name Minipress), silodosin (brand name Rapaflo), alfuzosin (brand name Uroxatral), terazosin (brand name Hytrin), and doxazosin (brand name Cardura).

Common side effects of tamsulosin include:

• Dizziness or lightheadedness
• Headache
• Runny nose, stuffy nose, or other “common cold” symptoms
• Abnormal ejaculation, such as ejaculation failure
• Drowsiness
• Diarrhea
• Intraoperative floppy iris syndrome (can occur during cataract surgery or glaucoma surgery) 

Serious side effects of tamsulosin can include:

• Chest pain (angina)
• Low blood pressure or fainting (syncope), especially when standing from a sitting position (also known as orthostatic hypotension)
• A severe allergic reaction with skin rash, swelling, and trouble breathing; if you have a history of an allergy to sulfonamide (“sulfa”) drugs, you may also have an allergic reaction to tamsulosin 

Tamsulosin also has potential drug interactions with several different medications, including PDE5 inhibitors used to treat erectile dysfunction and drugs that block the liver enzymes needed to break down tamsulosin. Let your healthcare provider know if you’re taking any other medications, whether over-the-counter or prescription drugs.

In the last few years, there’s been some controversy about whether tamsulosin increases the risk of dementia in the elderly.

A 2018 study examined Medicare data about men taking tamsulosin over a period of six years (2006-2012). The researchers found that taking tamsulosin may increase the risk of developing dementia.

However, a 2019 study pointed out several limitations of the study mentioned above. Using records from the National Health Insurance Database, South Korean researchers looked for a connection between α-blocker use and dementia inKorean adults with BPH between 2011 and 2017—they didn’t find one. The authors concluded that benign prostatic hyperplasia medication is not associated with a risk of dementia. It does not seem that tamsulosin definitively increases the risk of dementia in the elderly, but more research is needed. 

A study looking at the long-term safety and effectiveness of tamsulosin in men who took tamsulosin for six years found that some of the most common adverse effects included infection, accidental injury, runny nose, pain, and sore throat. Other reported side effects included abnormal ejaculation, syncope, and orthostatic hypotension. Interestingly, participants’ side effects declined over the six-year period, with the highest levels occurring in the first two years of treatment.

In summary, people taking tamsulosin to treat BPH urinary symptoms continued to have safe and well-tolerated relief of their symptoms for up to six years.  

If you stop taking tamsulosin (brand name Flomax) for a few days, talk with a healthcare provider before starting again. Your provider may have you restart at the lowest dose to prevent side effects.

If you experience any symptoms of BPH, it’s important to make an appointment with your healthcare provider as soon as possible. They will help you develop a safe and effective treatment plan to relieve your symptoms.

If you have any medical questions or concerns, please talk to your healthcare provider. The articles on Health Guide are underpinned by peer-reviewed research and information drawn from medical societies and governmental agencies. However, they are not a substitute for professional medical advice, diagnosis, or treatment.

1. American Urology Association (AUA). (2021). Urology Care Foundation: What is benign prostatic hyperplasia? Retrieved from https://www.urologyhealth.org/urologic-conditions/benign-prostatic-hyperplasia-(bph)
2. Duan, Y., Grady, J. J., Albertsen, P. C., et al. (2018). Tamsulosin and the risk of dementia in older men with benign prostatic hyperplasia. Pharmacoepidemiology and Drug Safety, 27(3), 340–348. Retrieved from https://doi.org/10.1002/pds.4361. Retrieved from https://pubmed.ncbi.nlm.nih.gov/29316005/
3. DailyMed. (2021). Tamsulosin hydrochloride capsule. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=339c3b57-a339-4578-bfd7-46b25d911ff6
4. Narayan, P. & Tunuguntla, H. S. (2005). Long-term efficacy and safety of tamsulosin for benign prostatic hyperplasia. Reviews in Urology, 7 Suppl 4(Suppl 4), S42–S48. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1477608/
5. Tae, B., Bum Sik Tae Department of Urology, Jeon, B., et al. (2019). α-Blocker and risk of dementia in patients with benign prostatic hyperplasia: a nationwide population based study using the national health insurance service database. The Journal of Urology, 202(2), 362–368. doi:10.1097/JU.0000000000000209Retrieved from https://www.auajournals.org/doi/10.1097/JU.0000000000000209

Dr. Chimene Richa is a board-certified Ophthalmologist and Senior Medical Writer/Reviewer at Ro.

What helps, side effects, radar, composition

Publication date: 04/24/2023

THERE ARE CONTRAINDICATIONS. POSSIBLE SIDE EFFECTS. A SPECIALIST’S CONSULTATION IS REQUIRED. Prostate adenoma Urinary incontinence

Author of the article

Ibrayeva Ekaterina Anatolyevna,

Diploma of pharmaceutical education: 105924 3510869 reg. number 31955

All authors

Contents of the article

• Tamsulosin: RLS
• Tamsulosin: why
• Tamsulosin: how long to take?
• Tamsulosin side effects
• Tamsulosin and alcohol compatibility
• Omnic or Tamsulosin: which is better?
• Silodosin or Tamsulosin: which is better?
• Urorek or Tamsulosin: which is better?
• Executive summary
• Ask an expert on the topic of the article

Benign prostatic hyperplasia (BPH, also known as prostate adenoma) is a benign tumor that occurs due to the growth of the glandular tissue of the prostate. At the same time, the outflow of urine is disturbed and there are frequent urges to go to the toilet. A man experiences difficulty with urination, feels a weakening of the urine stream, pressure in the bladder and a feeling of incomplete emptying. Without treatment, BPH develops complete urinary retention and inflammation of the kidneys and bladder.

The prevalence of adenoma increases with age, its causes are hormonal changes, overweight, obesity, hypertension. smoking and alcohol abuse. According to statistics, the growth of prostate tissue is detected in 40% of men about 50 years old and in 90% of men over 80 years old.

Adenoma has two ways of treatment: conservative (drug) and surgical. Two groups of drugs are used: 5-alpha reductase inhibitors and alpha-blockers. The latter includes the drug Tamsulosin. The pharmacist talks about the active substance, indications for use, terms of treatment, side effects and compatibility with alcohol. Compares with peers.

Tamsulosin: RLS

Tamsulosin contains the active ingredient of the same name. The drug blocks alpha1-adrenergic receptors in the muscles of the prostate gland, bladder neck and urethra. As a result, smooth muscle tone decreases and urination improves.

The drug is produced by Russian and Indian pharmaceutical companies in two dosage forms:

• Tamsulosin extended release capsules, 400 µg
• Tamsulosin extended release tablets, 400 mcg

For example, Tamsulosin-VERTEX and Tamsulosin Canon are available in both capsules and tablets. Both dosage forms are absorbed in the intestine and release the active substance gradually. Tablets maintain a constant concentration longer than capsules. Pellets in capsules contain sucrose, so they should not be taken by patients with sucrase deficiency, isomaltase deficiency and fructose intolerance.

All products Tamsulosin

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Tamsulosin: from what

According to the official instructions, the drug is prescribed for the treatment of bladder dysfunction in BPH. The drug helps with symptoms of the lower urinary tract (LUTS):

• frequent urination;
• nocturia – frequent urination at night;
• urinary incontinence;
• difficult or intermittent urination;
• weak pressure of urine;
• feeling of incomplete emptying of the bladder;
• instillation of urine.

There are medical prescriptions for Tamsulosin in chronic prostatitis in combination with other drugs and methods. In non-bacterial inflammation, it relieves symptoms such as frequent and difficult urination, thinning and lethargy of the urine stream, sudden urge and feeling of incomplete emptying.

Tamsulosin: how long to take?

Tamsulosin is taken on a long-term basis. The duration and effectiveness of treatment is determined by the attending physician.

The drug is taken once a day, after breakfast and washed down with a glass of water. Capsules and tablets are swallowed whole. The daily dose is equal to the dosage of 400 mcg in one tablet or capsule.

Tamsulosin side effects

Tamsulosin most commonly causes the following side effects in men:

• dizziness, headache;
• palpitations;
• pressure drop due to body position change;
• rhinitis;
• constipation, diarrhoea, nausea, vomiting;
• allergic skin reactions: rash, itching, urticaria;
• ejaculation disorders.

Tamsulosin and alcohol: compatibility

The official instructions for use do not contain information about the interaction of Tamsulosin and alcohol and their compatibility. Doctors recommend to refrain from drinking alcohol during treatment, so as not to aggravate the side effects of the drug.

Omnic or Tamsulosin: which is better?

Omnic is the original drug, Tamsulosin is its generic. Omnic is produced in capsules with modified release, Omnic Okas – in tablets with controlled release. Between themselves, they differ in the time to maintain a constant concentration of the drug in the blood and the severity of side effects. Eating reduces the absorption of capsules and does not affect the absorption of tablets. Such differences are due to different production technologies.

Omnic capsules have characteristics similar to Tamsulosin capsules, and Omnic Okas has characteristics similar to Tamsulosin tablets. The difference between analogues is in the quality of the active ingredient substance: for Omnik, raw materials from Japan, Ireland and the Netherlands are used, for Tamsulosin preparations – from India, Korea, and the Czech Republic.

In addition, Omnic and Tamsulosin tablets and capsules contain different excipients and base substances for the release of tamsulosin, which is reflected in their pharmaceutical equivalence.

Indications for use with analogues are identical. Omnic cost is higher. Subject to the dosage form prescribed by the doctor (tablets or capsules), drugs can be replaced. Omnic Okas and Tamsulosin tablets are more often prescribed to sexually active men, patients with cardiovascular diseases and the elderly.

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Silodosin or Tamsulosin: which is better?

Silodosin is a relatively new active ingredient in the treatment of BPH and has the highest selectivity for alpha1-adrenergic receptors of any alpha blocker for the treatment of BPH. It was first registered in 2006 in Japan. In Russia, it is represented by the drug Urorek.

The selectivity of silodosin to adrenoceptors of the prostate is 17 times greater than that of tamsulosin. Silodosin at a dose of 8 mg 1 time per day is superior to tamsulosin in reducing the number of nocturnal urges and urination, as well as in reducing the feeling of incomplete emptying of the bladder. But ejaculation disorders were significantly more common with silodosin (14%) than tamsulosin (2%).

Urorek or Tamsulosin: which is better?

Urorek’s active ingredient is silodosin, which reduces prostatic obstruction and lower urinary tract symptoms in BPH. The main properties of the drug are high selectivity to the subtype of alpha1-adrenergic receptors, the speed and persistence of the effect, and minimal risk of side effects.

Urorek comes in 8 mg capsules to be taken once a day at the same time. The drug can be used simultaneously with antihypertensive agents – it has fewer side effects from the cardiovascular system compared to Tamsulosin.

Urorek is effective in acute urinary retention. When administered to patients with kidney disease, a dose reduction is required. Not recommended for men who are sexually active

The choice of a particular drug is made by the doctor: he takes into account the age of the patient, the severity of symptoms, the severity of the disease and concomitant diseases.

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Summary

• Tamsulosin contains the active ingredient of the same name. The drug blocks alpha1-adrenergic receptors in the muscles of the prostate gland, bladder neck and urethra.
• According to the official instructions, the drug is prescribed for the treatment of bladder dysfunction in BPH. It helps with lower urinary tract symptoms (LUTS).
• Tamsulosin is taken on a long-term basis.
• Tamsulosin most commonly causes side effects: dizziness, headache, palpitations, pressure drop when changing body position, rhinitis, constipation, diarrhea, nausea, vomiting, allergic skin reactions, ejaculation disorders.
• Doctors recommend that you refrain from drinking alcohol during treatment, so as not to aggravate the side effects of the drug.
• If the dosage form prescribed by the doctor (tablets or capsules) is observed, drugs can be replaced. Omnic Okas and Tamsulosin tablets are more often prescribed to sexually active men, patients with cardiovascular diseases and the elderly.
• Silodosin is a relatively new active ingredient in the treatment of BPH and has the highest selectivity for alpha1-adrenergic receptors of any alpha blocker for the treatment of BPH.
• The choice of a specific drug is made by the doctor: he takes into account the age of the patient, the severity of symptoms, the severity of the disease and concomitant diseases.

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Duodart modified release capsules 0.5mg + 0.4mg №30

Composition

active ingredient: dutasteride, tamsulosin hydrochloride

1 capsule contains dutasteride 0 .5 mg and tamsulosin hydrochloride 0.4 mg,

excipients: caprylic acid monodiglycerides, butylhydroxytoluene (E 321), gelatin, glycerin, titanium dioxide (E171), iron oxide yellow (E172), medium chain triglycerides and lecithin, microcrystalline cellulose, methacrylate copolymer dispersion, talc, triethyl citrate, hard capsule shell : carrageenan (E 407), potassium chloride, titanium dioxide (E 171), FD&C Yellow 6 (E 110), hypromellose, carnauba wax, corn starch, iron oxide red (E 172), SW-9008 Black Ink (shellac, propylene glycol, black iron oxide (E172), potassium hydroxide).

Pharmacokinetics

Duodart ^® is a combination drug of dutasteride and tamsulosin with a complementary mechanism of action.

Dutasteride, a dual inhibitor of 5α,-reductase, inhibits the activity of 5α,-reductase types 1 and 2, which are responsible for the conversion of testosterone to 5α,-dihydrotestosterone. Dihydrotestosterone (DHT) is the main androgen responsible for hyperplasia of the glandular tissue of the prostate. Dutasteride lowers DHT levels, reduces the size of the prostate gland, reduces symptoms of the disease, improves urination, reduces the risk of acute urinary retention and the need for surgical treatment.

The maximum effect of dutasteride on the reduction of DHT concentration is dose-dependent and occurs 1-2 weeks after the start of treatment. After 1-2 weeks of taking dutasteride at a dose of 0.5 mg / day, the median values ​​​​of serum DHT concentrations are reduced by 85-90%, respectively.

In patients with benign prostatic hyperplasia (BPH), when taking dutasteride at a dose of 0. 5 mg / day, the average decrease in DHT levels was 94% during the first year and 93% during the second year of therapy, the average serum testosterone levels increased by 19% during the first and second years of treatment. This effect is due to a decrease in the level of 5α,-reductase and does not lead to the development of any known adverse reactions.

Tamsulosin hydrochloride is a blocker of postsynaptic &alpha, _1a -adrenergic receptors located in the smooth muscles of the prostate, bladder neck and prostatic part of the urethra. Blockade of &alpha, _1a -adrenergic receptors leads to a decrease in the tone of the smooth muscles of the prostate gland, bladder neck and prostatic part of the urethra and an improvement in urine outflow. At the same time, both obstructive symptoms and irritative symptoms decrease due to increased smooth muscle tone and detrusor hyperactivity in BPH. 9No rakty,

known hypersensitivity to tamsulosin hydrochloride, dutasteride , other 5-reductase inhibitors or any other ingredient of the drug.

Side effects

Adverse events associated with the use of tamsulosin hydrochloride in combination with dutasteride

Very rare (

Sexual disorders associated with the use of the dutasteride component and may persist after discontinuation of therapy.

Adverse events associated with the use of dutasteride as monotherapy

Adverse events associated with the use of tamsulosin hydrochloride as monotherapy

Common (&ge.1/100 and

0003

Rare (&ge.1/10000 and

Very rare (

Post-marketing studies

Intraoperative atonic iris syndrome (IFIS, a type of small pupil syndrome) has been observed during cataract surgery in some patients treated with alpha ₁ – adrenergic blockers, including tamsulosin hydrochloride

Atrial fibrillation, arrhythmia, tachycardia and dyspnea have been reported with tamsulosin.0003

Interactions

No drug interaction studies have been conducted with the combination of dutasteride with tamsulosin hydrochloride. The data below reflects the available information on the individual components.

Dutasteride

Dutasteride is metabolized by the CYP3A4 isoenzyme of the cytochrome P450 enzyme system. In the presence of CYP3A4 inhibitors, blood concentrations of dutasteride may increase.

With the simultaneous use of dutasteride with CYP3A4 inhibitors verapamil and diltiazem, there is a decrease in the clearance of dutasteride by 37% and 44%, respectively. However, amlodipine, another calcium channel blocker, does not decrease the clearance of dutasteride.

The decrease in dutasteride clearance and subsequent increase in its blood concentration with the simultaneous use of this drug and CYP3A4 inhibitors is not significant due to the wide range of safety margins of this drug, so there is no need to reduce its dose.

In vitro dutasteride is not metabolized by the following isoenzymes of the human cytochrome P450 system: CYP1A2, CYP2A6, CYP2E1, CYP2C8, CYP2C9, CYP2C19, CYP2B6 and CYP2D6.

Dutasteride does not inhibit in vitro enzymes of the human cytochrome P450 system involved in drug metabolism.

Dutasteride does not displace warfarin, acenocoumarol, phenprocoumon, diazepam and phenytoin from their plasma protein binding sites, and these drugs, in turn, do not displace dutasteride.

There was no effect on the pharmacokinetics and pharmacodynamics of the co-administration of dutasteride in combination with tamsulosin, terazosin, warfarin, digoxin and cholesteramine.

When dutasteride is used simultaneously with lipid-lowering drugs, ACE inhibitors, beta-blockers, calcium channel blockers, corticosteroids, diuretics, NSAIDs, PDE5 inhibitors and quinolone antibiotics, no significant drug interaction is noted.

Tamsulosin hydrochloride

There is a theoretical risk of increased hypotensive effect when tamsulosin hydrochloride is used in conjunction with drugs that can reduce blood pressure, including anesthetics, alpha ₁ -blockers and PDE5 inhibitors. Do not use Duodart in combination with other alpha ₁ -blockers.

Co-administration of tamsulosin and ketoconazole (a strong inhibitor of CYP3A4) results in increased C values ​​ _max and AUC of tamsulosin hydrochloride to 2.2 and 2.8, respectively. Co-administration of tamsulosin and paroxetine (a strong inhibitor of CYP2D6) leads to an increase in C _max and AUC of tamsulosin hydrochloride to 1.3 and 1.6, respectively. The co-administration of CYP2D6 and CYP3A4 inhibitors with tamsulosin has not been studied, but a significant increase in tamsulosin exposure is expected with this combination.

Simultaneous use of tamsulosin hydrochloride (0.4 mg) and cimetidine (400 mg every 6 hours) for 6 days resulted in a decrease in clearance (by 26%) and an increase in the AUC of tamsulosin hydrochloride (by 44%). Caution is required when co-administering Duodart with cimetidine.

Exhaustive drug interaction studies have not been conducted between tamsulosin hydrochloride and warfarin. Caution should be exercised with the simultaneous use of warfarin and tamsulosin hydrochloride.

Three studies in which tamsulosin hydrochloride (0.4 mg for 7 days, then 0.8 mg for the next 7 days) were co-administered with atenolol, enalapril, or nifedipine for 3 months showed no interaction and therefore no need for dose adjustments when these drugs are used together with Duodart.

Simultaneous use of tamsulosin hydrochloride (0.4 mg/day for 2 days, then 0.8 mg/day for 5-8 days) and single intravenous administration of theophylline (5 mg/kg) did not lead to a change in the pharmacokinetics of theophylline, therefore, no dose adjustment required.

Simultaneous use of tamsulosin hydrochloride (0.8 mg / day) and a single intravenous dose of furosemide (20 mg) resulted in a decrease of 11 to 12% C _max and AUC of tamsulosin hydrochloride, however, these changes are expected to be clinically insignificant and dose adjustment is not required.

Combination use of dutasteride and tamsulosin hydrochloride

In two 4-year clinical studies, the incidence of heart failure (composite term of reported events, mainly heart failure and congestive heart failure) was higher in patients treated with the combination of dutasteride and alpha ₁ -blocker, mainly tamsulosin hydrochloride, than in patients who did not receive combined treatment. In two 4-year clinical studies, the incidence of heart failure remained low (&le.1%) and varied between studies. But in general, there were no differences in the incidence of side effects from the cardiovascular system. No causal relationship has been established between treatment with dutasteride (alone or in combination with alpha ₁ – adrenoblocker) and heart failure.

Dosage and Administration

Adult men (including the elderly) are prescribed 1 capsule (0.5 mg/0.4 mg) orally, 1 time per day, 30 minutes after the same meal, with water.

Capsules should be taken whole, without opening or chewing, as contact of the contents of the capsule with the oral mucosa may cause inflammation of the mucosa.

There are currently no data on the use of Duodart in patients with impaired renal function.

No dose adjustment needed in this cohort of patients.

There are currently no data on the use of Duodart in patients with impaired liver function.

The drug should be used with caution in patients with mild to moderate hepatic impairment. Duodart is contraindicated in patients with severe hepatic impairment.

Overdose

There are no data on overdose when taking the combination of dutasteride with tamsulosin hydrochloride. The data below reflects the information available on the individual components.

Dutasteride

Symptoms: when using dutasteride at a dose of up to 40 mg / day (80 times higher than the therapeutic dose) for 7 days, no adverse events were noted. In clinical studies, when prescribing 5 mg / day for 6 months, no adverse reactions other than those listed for the therapeutic dose (0.5 mg / day) were noted.

Treatment: There is no specific antidote for dutasteride, so if an overdose is suspected, symptomatic and supportive treatment is sufficient.

Tamsulosin hydrochloride

Symptoms: overdose of tamsulosin hydrochloride may cause acute hypotension.

Treatment: symptomatic therapy. BP can be restored when a person takes a horizontal position. If there is no effect, agents that increase the BCC and, if necessary, vasoconstrictors, can be used. It is necessary to monitor kidney function. It is unlikely that dialysis will be effective because tamsulosin hydrochloride is bound to plasma proteins by 94-99%.

Special instructions

Dutasteride is absorbed through the skin, so women and children should avoid contact with damaged capsules. In case of contact with damaged capsules, immediately wash the affected skin area with soap and water.

Co-administration of tamsulosin with strong inhibitors of CYP3A4 (ketoconazole), CYP2D6 (paroxetine) and their weaker inhibitors results in increased exposure to tamsulosin. Thus, the use of tamsulosin in combination with strong inhibitors of CYP3A4 is not recommended, the combination of CYP2D6 inhibitors and tamsulosin should be administered with caution.

Since the T _1/2 of dutasteride is 3-5 weeks and is metabolized primarily in the liver, Duodart should be used with caution in patients with liver disease.

Combination therapy with tamsulosin hydrochloride and development of heart failure

In two 4-year clinical studies, the incidence of heart failure (composite term of reported events, mainly heart failure and congestive heart failure) was higher in patients treated with a combination of dutasteride and alpha ₁ -blocker, mainly tamsulosin hydrochloride, than in patients who did not receive combined treatment. In two 4-year clinical studies, the incidence of heart failure remained low (&le.1%) and varied between studies. But in general, there were no differences in the incidence of side effects from the cardiovascular system. No causal relationship has been established between treatment with dutasteride (alone or in combination with alpha ₁ -adrenergic blocker) and heart failure.

Influence on detection of PSA and prostate cancer

In patients with BPH, digital rectal examination and other prostate examinations should be performed before initiation of treatment with Duodart and periodically repeated during treatment to exclude the development of prostate cancer.

Serum PSA concentrations are an essential component of the screening process for prostate cancer.

After 6 months of therapy, dutasteride reduces serum PSA levels in patients with BPH by approximately 50%.

Patients taking Duodart should have a new baseline PSA level determined after 6 months of therapy.

Any persistent increase in PSA levels from the trough of Duodart treatment may indicate the development of prostate cancer (particularly high-grade Gleason prostate cancer) or non-compliance with Duodart therapy and should be carefully evaluated, even if these PSA levels remain within normal ranges in patients not taking 5-reductase inhibitors.

Total PSA returns to baseline within 6 months after discontinuation of dutasteride.

The ratio of free to total PSA remains constant even during dutasteride therapy. When this ratio is expressed in proportions for the detection of prostate cancer in men receiving dutasteride, no correction of this value is required.

Risk of developing breast cancer

In clinical studies during the treatment of BPH, 2 cases of breast cancer have been identified in patients treated with dutasteride. The first case developed 10 weeks after the start of therapy, the second after 11 months, and 1 case of breast cancer was also detected in a patient from the placebo group. The relationship between long-term use of dutasteride and the risk of developing breast cancer is unknown.

Prostate cancer

In a clinical study over 4 years, 1517 of more than 8000 men with preliminary negative biopsy results and a PSA level of 2.5-10 ng/ml were diagnosed with prostate cancer. There was a higher incidence of cancer in patients in the dutasteride group (n=29, 0.9%) compared with the placebo group (n=19, 0.6%). No interaction has been established between dutasteride and the grade of prostate cancer. Men taking dutasteride should be screened regularly for risk of prostate cancer, including a PSA test.

Arterial hypotension

As with the use of any alpha ₁ -blockers, orthostatic hypotension may occur with the use of tamsulosin hydrochloride, in rare cases leading to syncope.

Patients starting treatment with Duodart should be advised to sit or lie down at the first sign of orthostatic hypotension (dizziness) until the dizziness subsides.

Caution should be exercised when coadministering alfa 9 to avoid symptomatic hypotension0193 1 -blockers and PDE5 inhibitors, because these drugs belong to the group of vasodilators and can lead to a decrease in blood pressure.

Floppy iris syndrome

Intraoperative atonic iris syndrome (IFIS, a type of small pupil syndrome) has been observed during cataract surgery in some patients treated with alpha ₁ -blockers, including tamsulosin hydrochloride. Atonic iris syndrome can lead to an increase in the number of complications during operations.

During the preoperative examination, the ophthalmic surgeon should clarify whether the patient is taking a combination of dutasteride with tamsulosin hydrochloride in order to be able to prepare for surgery, and to take adequate measures if iris atony occurs intraoperatively.