Uroblock
Generic Name
Mirabegron
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
uroblock 50 mg tablet | ৳ 55.00 | ৳ 550.00 |
Description
Overview of the medicine
Uroblock 50 mg Tablet contains Mirabegron, a beta-3 adrenoceptor agonist. It is used to treat symptoms of overactive bladder (OAB) in adults, such as sudden urges to urinate, needing to urinate frequently, and not being able to control when you urinate (urge incontinence).
Uses & Indications
Dosage
Adults
The recommended starting dose is 25 mg once daily. Based on efficacy and tolerability, the dose can be increased to 50 mg once daily.
Elderly
No dosage adjustment is required based on age alone. However, caution should be exercised in elderly patients with renal or hepatic impairment.
Renal_impairment
Mild to moderate (CrCl 30-89 mL/min): No dose adjustment. Severe (CrCl 15-29 mL/min): Maximum 25 mg once daily. End-stage renal disease (CrCl < 15 mL/min or on hemodialysis): Not recommended.
How to Take
Take one tablet orally once daily with water. It can be taken with or without food. Swallow the tablet whole; do not chew or crush it.
Mechanism of Action
Mirabegron selectively activates beta-3 adrenergic receptors in the detrusor muscle of the bladder, leading to relaxation of the detrusor muscle during the urine storage phase. This increases bladder capacity and reduces the frequency of spontaneous detrusor contractions, thereby alleviating OAB symptoms.
Pharmacokinetics
Onset
Clinical effects may be observed within 8 weeks, with some improvement seen earlier.
Excretion
Mainly renal (approximately 55%), with some fecal excretion (approximately 34%).
Half life
Approximately 32 hours.
Absorption
Slowly absorbed, absolute bioavailability is 29% for 50 mg. Peak plasma concentrations (Cmax) are generally reached within 3.5 to 4 hours.
Metabolism
Primarily metabolized by CYP2D6 and CYP3A4, as well as butyrylcholinesterase and uridine diphosphate glucuronosyltransferases (UGT).
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Uncontrolled severe hypertension (systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg).
- End-stage renal disease (CrCl < 15 mL/min or patients on hemodialysis).
- Severe hepatic impairment (Child-Pugh Class C).
Drug Interactions
Warfarin
No clinically significant interaction observed.
Moderate CYP2D6 inhibitors
Mirabegron is a moderate CYP2D6 inhibitor. Co-administration with drugs primarily metabolized by CYP2D6 (e.g., desipramine, metoprolol, flecainide, propafenone, thioridazine) may increase their plasma concentrations. Caution is advised.
P-glycoprotein (P-gp) substrates
Mirabegron is a weak P-gp inhibitor. Co-administration with P-gp substrates (e.g., digoxin) may increase their plasma concentrations. Digoxin levels should be monitored.
Storage
Store below 30°C in a dry place, away from direct light and moisture.
Overdose
Overdose with Mirabegron has been associated with increases in heart rate and palpitations. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category C. Mirabegron should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether Mirabegron is excreted in human milk; caution should be exercised when administered to a breastfeeding woman.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Uncontrolled severe hypertension (systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg).
- End-stage renal disease (CrCl < 15 mL/min or patients on hemodialysis).
- Severe hepatic impairment (Child-Pugh Class C).
Drug Interactions
Warfarin
No clinically significant interaction observed.
Moderate CYP2D6 inhibitors
Mirabegron is a moderate CYP2D6 inhibitor. Co-administration with drugs primarily metabolized by CYP2D6 (e.g., desipramine, metoprolol, flecainide, propafenone, thioridazine) may increase their plasma concentrations. Caution is advised.
P-glycoprotein (P-gp) substrates
Mirabegron is a weak P-gp inhibitor. Co-administration with P-gp substrates (e.g., digoxin) may increase their plasma concentrations. Digoxin levels should be monitored.
Storage
Store below 30°C in a dry place, away from direct light and moisture.
Overdose
Overdose with Mirabegron has been associated with increases in heart rate and palpitations. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category C. Mirabegron should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether Mirabegron is excreted in human milk; caution should be exercised when administered to a breastfeeding woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date
Availability
Available in pharmacies nationwide
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Patented, or patent protected
Clinical Trials
Mirabegron has been extensively studied in multiple Phase 3 clinical trials demonstrating its efficacy and safety in adult patients with overactive bladder.
Lab Monitoring
- Blood pressure monitoring, especially in patients with pre-existing hypertension.
- Monitoring of serum digoxin levels if co-administered with digoxin.
Doctor Notes
- Monitor blood pressure regularly, particularly at the start of treatment and in patients with hypertension.
- Assess for signs of urinary retention, especially in patients with clinically significant bladder outflow obstruction (BOO) or on concomitant antimuscarinic therapy.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not chew, crush, or break the tablet; swallow it whole.
- Inform your doctor if you experience any sudden increase in blood pressure or difficulty emptying your bladder.
- Keep out of reach of children.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Dizziness has been reported with Mirabegron. Patients should be cautious when driving or operating machinery until they know how Uroblock affects them.
Lifestyle Advice
- Maintain good hydration, but avoid excessive intake of caffeine and alcohol, as these can irritate the bladder.
- Pelvic floor exercises (Kegel exercises) may help improve bladder control.
- Consider bladder training techniques under medical guidance.
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