Uromax-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 |
|---|---|---|
| uromax d 04 mg capsule | ৳ 23.00 | ৳ 115.00 |
Description
Overview of the medicine
Uromax-D 0.4 mg capsule is a combination medicine containing Tamsulosin and Dutasteride. It is primarily used for the treatment of symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate, aiming to reduce prostate size and improve urine flow.
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 dosage adjustment is generally required in the elderly.
Renal_impairment
No dosage adjustment is generally required in patients with renal impairment.
How to Take
Oral administration. The capsule should be swallowed whole with water, not chewed or opened. It should be taken approximately 30 minutes after the same meal each day.
Mechanism of Action
Tamsulosin, an alpha-1 adrenoceptor antagonist, selectively blocks alpha-1 receptors in the prostate, bladder neck, and prostatic urethra, causing relaxation of smooth muscle and improving urine flow. Dutasteride, a 5-alpha reductase inhibitor, prevents the conversion of testosterone to dihydrotestosterone (DHT), thereby reducing prostate volume.
Pharmacokinetics
Onset
Tamsulosin: Within days; Dutasteride: Several months for prostate size reduction, but symptom improvement from Tamsulosin starts earlier.
Excretion
Tamsulosin: Primarily in urine (as metabolites and unchanged drug). Dutasteride: Primarily in feces, less than 5% in urine (as metabolites).
Half life
Tamsulosin: 5-7 hours; Dutasteride: 3-5 weeks.
Absorption
Tamsulosin is well absorbed, about 90% in fasting state. Dutasteride is well absorbed, reaching peak levels in 1-3 hours.
Metabolism
Tamsulosin: Metabolized in the liver (CYP3A4, CYP2D6). Dutasteride: Extensively metabolized by CYP3A4/5.
Side Effects
Contraindications
- Hypersensitivity to Tamsulosin, Dutasteride, other 5-alpha reductase inhibitors, or any excipients
- Women (due to potential risk to male fetus in pregnancy)
- Children and adolescents
- Severe hepatic impairment
- History of orthostatic hypotension
Drug Interactions
Warfarin
Caution advised.
Other alpha-1 blockers
Increased risk of hypotension.
Potent CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase Tamsulosin and Dutasteride concentrations.
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 hypotension (dizziness, fainting) due to Tamsulosin and prolonged exposure to Dutasteride. Treatment is supportive, including lying patient supine to restore blood pressure and heart rate, and possibly vasopressors and fluid replacement. Induction of emesis or gastric lavage may be considered soon after ingestion.
Pregnancy & Lactation
Uromax-D is contraindicated in women, especially those who are pregnant or may become pregnant, due to the risk of male fetal abnormalities. Dutasteride can be absorbed through the skin, so women and children should avoid contact with leaking capsules. It is unknown if Tamsulosin or Dutasteride are excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to Tamsulosin, Dutasteride, other 5-alpha reductase inhibitors, or any excipients
- Women (due to potential risk to male fetus in pregnancy)
- Children and adolescents
- Severe hepatic impairment
- History of orthostatic hypotension
Drug Interactions
Warfarin
Caution advised.
Other alpha-1 blockers
Increased risk of hypotension.
Potent CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase Tamsulosin and Dutasteride concentrations.
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 hypotension (dizziness, fainting) due to Tamsulosin and prolonged exposure to Dutasteride. Treatment is supportive, including lying patient supine to restore blood pressure and heart rate, and possibly vasopressors and fluid replacement. Induction of emesis or gastric lavage may be considered soon after ingestion.
Pregnancy & Lactation
Uromax-D is contraindicated in women, especially those who are pregnant or may become pregnant, due to the risk of male fetal abnormalities. Dutasteride can be absorbed through the skin, so women and children should avoid contact with leaking capsules. It is unknown if Tamsulosin or Dutasteride are excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Generic versions available, original patent expired
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of the Tamsulosin-Dutasteride combination in improving BPH symptoms, reducing prostate volume, and preventing disease progression.
Lab Monitoring
- Prostate-Specific Antigen (PSA) levels: Dutasteride can decrease PSA levels, which should be considered when interpreting PSA test results for prostate cancer screening.
- Liver function tests: Periodically for patients with pre-existing hepatic impairment or those on long-term therapy.
Doctor Notes
- Counsel patients on potential sexual side effects and orthostatic hypotension.
- Remind patients that PSA levels should be re-evaluated 3-6 months after starting therapy for accurate interpretation for prostate cancer screening.
- Advise caution if co-administering with strong CYP3A4 inhibitors.
- Warning for pregnant women to avoid contact with capsules.
Patient Guidelines
- Take the capsule whole, do not chew or open.
- Take with water approximately 30 minutes after the same meal each day.
- Be aware of potential dizziness or lightheadedness, especially when standing up from a sitting or lying position.
- Report any vision problems during cataract or glaucoma surgery (Floppy Iris Syndrome).
- Women and children should avoid contact with leaking capsules.
- Discuss family history of prostate cancer and current medications with your doctor.
Missed Dose Advice
If a dose is missed, it should be taken as soon as remembered. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, lightheadedness, or fainting, especially at the start of treatment or when changing position. Patients should be warned about these potential effects and advised not to drive or operate machinery if they experience them.
Lifestyle Advice
- Maintain a healthy diet and regular exercise.
- Limit caffeine and alcohol intake.
- Avoid excessive fluid intake before bedtime.
- Practice pelvic floor exercises.
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