Tamsin-D
Generic Name
Tamsulosin Hydrochloride 0.4 mg + Dutasteride 0.5 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tamsin d 04 mg capsule | ৳ 20.00 | ৳ 120.00 |
Description
Overview of the medicine
Tamsin-D is a combination medicine containing Tamsulosin and Dutasteride, used to treat symptoms of benign prostatic hyperplasia (BPH) in men. Tamsulosin helps relax the muscles in the prostate and bladder, improving urine flow, while Dutasteride reduces the size of the enlarged prostate.
Uses & Indications
Dosage
Adults
One capsule (Tamsulosin 0.4 mg + Dutasteride 0.5 mg) once daily, approximately 30 minutes after the same meal each day.
Elderly
No dose adjustment is considered necessary for elderly patients.
Renal_impairment
No dose adjustment is considered necessary for patients with renal impairment.
How to Take
Take the capsule orally with water, approximately 30 minutes after the same meal each day. Swallow the capsule whole; do not crush, chew, or open it.
Mechanism of Action
Tamsulosin is an alpha-1A adrenergic receptor antagonist that relaxes smooth muscles in the prostate and bladder neck, improving urine flow. Dutasteride is a 5-alpha-reductase inhibitor that prevents the conversion of testosterone to dihydrotestosterone (DHT), thereby shrinking the enlarged prostate.
Pharmacokinetics
Onset
Tamsulosin: Symptomatic improvement typically within 2-4 weeks. Dutasteride: Prostate size reduction over 3-6 months; symptomatic improvement may take longer.
Excretion
Tamsulosin is primarily excreted in the urine (as metabolites and unchanged drug). Dutasteride is primarily excreted in the feces (as metabolites and unchanged drug).
Half life
Tamsulosin: Approximately 10-14 hours. Dutasteride: Approximately 3-5 weeks.
Absorption
Tamsulosin is rapidly and almost completely absorbed from the gastrointestinal tract. Dutasteride is well absorbed after oral administration, with peak serum concentrations reached within 1 to 3 hours.
Metabolism
Both Tamsulosin and Dutasteride are extensively metabolized in the liver, primarily via CYP3A4 and CYP2D6 (Tamsulosin) and CYP3A4/5 (Dutasteride).
Side Effects
Contraindications
- Hypersensitivity to Tamsulosin, Dutasteride, other 5-alpha-reductase inhibitors, or any component of the formulation
- Women (due to risk of male fetal feminization)
- Children and adolescents
- Severe hepatic impairment
- History of orthostatic hypotension
Drug Interactions
Warfarin
Limited data, but caution advised with Dutasteride.
PDE5 inhibitors (e.g., Sildenafil, Tadalafil)
Use with caution due to potential for additive blood pressure lowering effects.
Strong CYP3A4 inhibitors (e.g., Ketoconazole)
May increase plasma levels of Tamsulosin and Dutasteride, potentially increasing side effects. Use with caution.
Other alpha-1 blockers (e.g., Prazosin, Terazosin)
Concomitant use may lead to enhanced hypotensive effects. Avoid concurrent use.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose primarily relate to Tamsulosin and may include severe hypotension, dizziness, and compensatory tachycardia. Management is symptomatic and supportive, including keeping the patient supine and administering fluids/vasopressors if necessary. Dutasteride overdose data is limited.
Pregnancy & Lactation
This medicine is contraindicated in women, especially during pregnancy, due to the risk of male fetal feminization by Dutasteride. It is not indicated for use in women and should not be handled by women who are pregnant or planning to become pregnant due to the risk of dermal absorption.
Side Effects
Contraindications
- Hypersensitivity to Tamsulosin, Dutasteride, other 5-alpha-reductase inhibitors, or any component of the formulation
- Women (due to risk of male fetal feminization)
- Children and adolescents
- Severe hepatic impairment
- History of orthostatic hypotension
Drug Interactions
Warfarin
Limited data, but caution advised with Dutasteride.
PDE5 inhibitors (e.g., Sildenafil, Tadalafil)
Use with caution due to potential for additive blood pressure lowering effects.
Strong CYP3A4 inhibitors (e.g., Ketoconazole)
May increase plasma levels of Tamsulosin and Dutasteride, potentially increasing side effects. Use with caution.
Other alpha-1 blockers (e.g., Prazosin, Terazosin)
Concomitant use may lead to enhanced hypotensive effects. Avoid concurrent use.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose primarily relate to Tamsulosin and may include severe hypotension, dizziness, and compensatory tachycardia. Management is symptomatic and supportive, including keeping the patient supine and administering fluids/vasopressors if necessary. Dutasteride overdose data is limited.
Pregnancy & Lactation
This medicine is contraindicated in women, especially during pregnancy, due to the risk of male fetal feminization by Dutasteride. It is not indicated for use in women and should not be handled by women who are pregnant or planning to become pregnant due to the risk of dermal absorption.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, depending on storage conditions.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA, FDA, EMA)
Patent Status
Off-patent (generic versions available)
Clinical Trials
Clinical trials have demonstrated the superior efficacy of the Tamsulosin and Dutasteride combination in improving BPH symptoms and reducing the risk of BPH progression compared to either monotherapy, particularly in men with larger prostates and more severe symptoms.
Lab Monitoring
- Prostate-Specific Antigen (PSA) levels: Dutasteride can lower PSA levels, which may affect prostate cancer screening. Baseline PSA should be established before starting treatment.
- Liver function tests: Periodically, especially in patients with pre-existing hepatic impairment.
Doctor Notes
- Counsel patients on the potential for orthostatic hypotension, especially at the start of therapy.
- Inform patients about the risk of Intraoperative Floppy Iris Syndrome (IFIS) if cataract surgery is planned, and advise them to inform their ophthalmologist about Tamsulosin use.
- Discuss the impact of Dutasteride on PSA levels and its implications for prostate cancer detection.
- Advise women of childbearing potential to avoid contact with broken or leaking capsules due to the risk of dermal absorption of Dutasteride.
Patient Guidelines
- Take the medicine as prescribed by your doctor, do not stop or change the dose without consultation.
- Swallow the capsule whole; do not crush, chew, or open it.
- Be careful when standing up from a sitting or lying position to avoid dizziness.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Inform your ophthalmologist about Tamsulosin use before cataract surgery.
Missed Dose Advice
If you miss a dose, do not take a double dose to make up for it. Simply take the next scheduled dose as usual. Do not take two doses at the same time.
Driving Precautions
This medicine may cause dizziness or lightheadedness, especially at the beginning of treatment. If you experience these symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy lifestyle, including a balanced diet and regular exercise.
- Avoid sudden changes in body position.
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