Uroflo-Plus
Generic Name
Tamsulosin Hydrochloride + Dutasteride
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
uroflo plus 04 mg capsule | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Uroflo-Plus 0.4 mg Capsule is a combination medicine containing Tamsulosin and Dutasteride. It is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Tamsulosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate. Dutasteride shrinks the enlarged prostate by blocking the production of a natural hormone.
Uses & Indications
Dosage
Adults
One capsule (Tamsulosin 0.4 mg + Dutasteride 0.5 mg) once daily, taken approximately 30 minutes after the same meal each day.
Elderly
No dosage adjustment required.
Renal_impairment
No dosage adjustment required for mild to moderate renal impairment. Caution in severe impairment.
How to Take
Swallow the capsule whole. Do not chew, crush, or open the capsule. Take approximately 30 minutes after the same meal each day.
Mechanism of Action
Tamsulosin is an alpha-1A adrenergic receptor antagonist, relaxing smooth muscles in the prostate and bladder neck, reducing bladder outlet obstruction. Dutasteride is a dual 5-alpha reductase inhibitor, blocking the conversion of testosterone to dihydrotestosterone (DHT), which is responsible for prostatic growth.
Pharmacokinetics
Onset
Tamsulosin: Symptomatic improvement typically within 2-4 weeks. Dutasteride: Prostate shrinkage and symptomatic relief may take 3-6 months.
Excretion
Tamsulosin: Primarily in urine. Dutasteride: Primarily in feces as metabolites.
Half life
Tamsulosin: Approximately 9-15 hours. Dutasteride: Approximately 3-5 weeks.
Absorption
Tamsulosin: Well absorbed, approximately 90%. Dutasteride: Well absorbed, peak plasma concentrations occur within 1 to 3 hours.
Metabolism
Tamsulosin: Extensively metabolized by cytochrome P450 enzymes in the liver. Dutasteride: Extensively metabolized by CYP3A4 and CYP2C9.
Side Effects
Contraindications
- Hypersensitivity to Tamsulosin, Dutasteride, other 5-alpha reductase inhibitors, or any component of the formulation.
- Women and children.
- Severe hepatic impairment.
Drug Interactions
Warfarin
Dutasteride may interact, leading to changes in INR (though clinical significance is limited).
Alpha-adrenergic blockers (other)
Increased risk of hypotension.
PDE5 inhibitors (e.g., Sildenafil, Tadalafil)
Increased risk of hypotension when co-administered with Tamsulosin.
Potent CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase Tamsulosin and Dutasteride levels. Use with caution.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe hypotension. Treatment is supportive and symptomatic, including monitoring vital signs and cardiovascular support. Intravenous fluids and vasopressors may be necessary.
Pregnancy & Lactation
Contraindicated in women. Dutasteride can cause feminization of a male fetus. Excreted in semen, so male partners of pregnant women should use condoms. Not applicable for lactation.
Side Effects
Contraindications
- Hypersensitivity to Tamsulosin, Dutasteride, other 5-alpha reductase inhibitors, or any component of the formulation.
- Women and children.
- Severe hepatic impairment.
Drug Interactions
Warfarin
Dutasteride may interact, leading to changes in INR (though clinical significance is limited).
Alpha-adrenergic blockers (other)
Increased risk of hypotension.
PDE5 inhibitors (e.g., Sildenafil, Tadalafil)
Increased risk of hypotension when co-administered with Tamsulosin.
Potent CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase Tamsulosin and Dutasteride levels. Use with caution.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe hypotension. Treatment is supportive and symptomatic, including monitoring vital signs and cardiovascular support. Intravenous fluids and vasopressors may be necessary.
Pregnancy & Lactation
Contraindicated in women. Dutasteride can cause feminization of a male fetus. Excreted in semen, so male partners of pregnant women should use condoms. Not applicable for lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generics available
Clinical Trials
Combination therapy with Tamsulosin and Dutasteride has shown superior efficacy compared to monotherapy with either agent in reducing BPH symptoms and progression, as demonstrated in studies like the CombAT (Combination of Alpha-Blocker and 5-Alpha Reductase Inhibitor) study.
Lab Monitoring
- Prostate-specific antigen (PSA) levels: Dutasteride can lower PSA levels, so a baseline PSA and regular monitoring are important. Adjust PSA values accordingly (multiply by 2 for comparison to untreated values after 6 months of therapy).
- Liver function tests (LFTs) if hepatic impairment is suspected.
Doctor Notes
- Counsel patients on potential sexual side effects and the importance of continued therapy for Dutasteride's full effect.
- Emphasize not handling capsules by women of childbearing potential.
- Monitor PSA levels and educate patients on its interpretation in the context of Dutasteride use.
- Advise patients to inform surgeons about Tamsulosin use before cataract/glaucoma surgery.
Patient Guidelines
- Take the medicine at the same time each day, after a meal.
- Do not chew, crush, or open the capsule.
- Inform your doctor about all medications you are taking, including over-the-counter drugs and herbal supplements.
- Women and children should not handle the capsules.
- If you are undergoing cataract or glaucoma surgery, inform your eye doctor that you are taking Tamsulosin, as it can cause Intraoperative Floppy Iris Syndrome (IFIS).
- Dutasteride can affect PSA levels, so inform your doctor if you are having a PSA test.
Missed Dose Advice
If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness or lightheadedness, especially when starting treatment or changing dose. Avoid driving or operating machinery until you know how it affects you.
Lifestyle Advice
- Maintain a healthy weight.
- Limit caffeine and alcohol intake.
- Avoid fluids before bedtime.
- Engage in regular physical activity.
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