Uroflo Plus
Generic Name
Tamsulosin HCl + Solifenacin Succinate
Manufacturer
Square 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 is a combination medication used to treat symptoms associated with benign prostatic hyperplasia (BPH) and overactive bladder (OAB). It combines Tamsulosin, an alpha-blocker, which relaxes the muscles in the prostate and bladder neck, and Solifenacin, an antimuscarinic, which reduces bladder muscle contractions.
Uses & Indications
Dosage
Adults
One tablet (Tamsulosin 0.4 mg + Solifenacin 5 mg) orally once daily. Maximum dose is one tablet daily.
Elderly
No dose adjustment is generally required, but caution is advised in patients over 75 years.
Renal_impairment
Mild to moderate renal impairment: No dose adjustment needed. Severe renal impairment: Use with caution, consult physician.
How to Take
Take orally once daily with or without food, preferably at the same time each day. Swallow the tablet whole; do not chew, crush, or break it.
Mechanism of Action
Tamsulosin selectively blocks alpha-1A and alpha-1D adrenergic receptors, primarily located in the prostate, prostatic capsule, bladder neck, and prostatic urethra, leading to relaxation of smooth muscles and improved urine flow. Solifenacin is a competitive muscarinic receptor antagonist, reducing involuntary bladder contractions associated with overactive bladder.
Pharmacokinetics
Onset
Tamsulosin: Clinical effects may take several days to weeks. Solifenacin: Effects within a few hours, full effects within weeks.
Excretion
Both primarily excreted in urine (metabolites and unchanged drug) and feces (Solifenacin).
Half life
Tamsulosin: Approximately 9-15 hours. Solifenacin: Approximately 45-68 hours.
Absorption
Tamsulosin: Well absorbed, nearly complete bioavailability. Solifenacin: Slowly and well absorbed, 90% bioavailability. Both achieve peak plasma concentrations within 4-8 hours.
Metabolism
Both primarily metabolized in the liver, mainly by CYP3A4 and to a lesser extent CYP2D6 (Tamsulosin) and CYP3A4 (Solifenacin).
Side Effects
Contraindications
- Hypersensitivity to Tamsulosin, Solifenacin, or any component of the formulation.
- Severe hepatic impairment.
- Severe renal impairment (CrCl < 30 mL/min).
- Severe gastrointestinal conditions (e.g., toxic megacolon).
- Closed-angle glaucoma (Solifenacin component).
- Urinary retention (Solifenacin component).
- Micturition syncope history (Tamsulosin component).
Drug Interactions
Digoxin
Solifenacin may increase digoxin levels.
Other alpha-blockers
Increased risk of hypotension. Avoid concomitant use.
Anticholinergic agents (e.g., Atropine)
Additive anticholinergic effects, increased risk of side effects like dry mouth, constipation, urinary retention.
Potent CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May significantly increase plasma levels of Tamsulosin and Solifenacin. Use with caution or avoid.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Tamsulosin overdose include severe hypotension. Solifenacin overdose symptoms include severe anticholinergic effects like severe dry mouth, constipation, blurred vision, urinary retention, tachycardia. Management is supportive and symptomatic, including gastric lavage, activated charcoal, and appropriate medical intervention for specific symptoms.
Pregnancy & Lactation
This medication is not indicated for use in women. Not recommended during breastfeeding due to potential excretion into breast milk.
Side Effects
Contraindications
- Hypersensitivity to Tamsulosin, Solifenacin, or any component of the formulation.
- Severe hepatic impairment.
- Severe renal impairment (CrCl < 30 mL/min).
- Severe gastrointestinal conditions (e.g., toxic megacolon).
- Closed-angle glaucoma (Solifenacin component).
- Urinary retention (Solifenacin component).
- Micturition syncope history (Tamsulosin component).
Drug Interactions
Digoxin
Solifenacin may increase digoxin levels.
Other alpha-blockers
Increased risk of hypotension. Avoid concomitant use.
Anticholinergic agents (e.g., Atropine)
Additive anticholinergic effects, increased risk of side effects like dry mouth, constipation, urinary retention.
Potent CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May significantly increase plasma levels of Tamsulosin and Solifenacin. Use with caution or avoid.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Tamsulosin overdose include severe hypotension. Solifenacin overdose symptoms include severe anticholinergic effects like severe dry mouth, constipation, blurred vision, urinary retention, tachycardia. Management is supportive and symptomatic, including gastric lavage, activated charcoal, and appropriate medical intervention for specific symptoms.
Pregnancy & Lactation
This medication is not indicated for use in women. Not recommended during breastfeeding due to potential excretion into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24-36 months from manufacturing date.
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Off-patent (Generics available)
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Tamsulosin and Solifenacin in treating BPH and OAB symptoms, both individually and in combination.
Lab Monitoring
- Monitor blood pressure regularly, especially at the start of treatment.
- Monitor renal function in patients with kidney impairment.
Doctor Notes
- Advise patients about potential orthostatic hypotension, especially at the initiation of therapy.
- Counsel on the risk of IFIS for patients undergoing cataract surgery.
- Caution in patients with prolonged QT interval or taking other drugs that prolong QT interval (Solifenacin).
Patient Guidelines
- Take the medication as prescribed by your doctor.
- Do not crush or chew the tablet.
- Report any severe dizziness, fainting, or vision changes to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness, drowsiness, or blurred vision. Avoid driving or operating heavy machinery until you know how this medicine affects you.
Lifestyle Advice
- Maintain adequate hydration.
- Avoid sudden changes in posture to prevent dizziness.
- Limit caffeine and alcohol intake, as they can worsen urinary symptoms.
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