Miraba
Generic Name
Mirabegron
Manufacturer
General Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| miraba 25 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Mirabegron is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Uses & Indications
Dosage
Adults
The recommended starting dose is 25 mg orally once daily. Based on individual patient efficacy and tolerability, the dose may be increased to 50 mg orally once daily.
Elderly
No dosage adjustment is required for elderly patients (≥65 years of age).
Renal_impairment
For severe renal impairment (CrCl 15 to 29 mL/min), the daily dose should not exceed 25 mg. Mirabegron is not recommended for patients with end-stage renal disease (ESRD) or on hemodialysis.
How to Take
Take orally with or without food. Swallow the tablet whole with water; do not chew, divide, or crush it.
Mechanism of Action
Mirabegron activates beta-3 adrenergic receptors in the bladder detrusor muscle, leading to muscle relaxation and increased bladder capacity. This reduces bladder contractions and the symptoms associated with OAB.
Pharmacokinetics
Onset
Clinical effects typically observed within a few hours to days, with full therapeutic effect often seen after several weeks of continuous treatment.
Excretion
Approximately 55% of the administered dose is excreted renally, with about 25% as unchanged mirabegron. The remaining is excreted via feces.
Half life
Mean terminal elimination half-life is approximately 50 hours.
Absorption
Relatively slow absorption with a time to maximum plasma concentration (Tmax) of approximately 3.5 hours. Bioavailability is about 29% for a 25 mg dose.
Metabolism
Undergoes extensive metabolism via multiple pathways including N-dealkylation, oxidation, glucuronidation, and amide hydrolysis. CYP2D6 is involved but not rate-limiting.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg).
Drug Interactions
Warfarin
No clinically significant interaction observed.
CYP2D6 inhibitors/substrates
Mirabegron is a moderate CYP2D6 inhibitor. Co-administration with CYP2D6 substrates with narrow therapeutic index (e.g., Thioridazine, Flecainide, Propafenone) may require dose adjustment. Digoxin levels may increase, monitor digoxin levels.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may result in increased heart rate, palpitations, and increased blood pressure. Treatment should be symptomatic and supportive. Monitor vital signs and provide general supportive measures.
Pregnancy & Lactation
Pregnancy Category C. Use 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 nursing woman.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg).
Drug Interactions
Warfarin
No clinically significant interaction observed.
CYP2D6 inhibitors/substrates
Mirabegron is a moderate CYP2D6 inhibitor. Co-administration with CYP2D6 substrates with narrow therapeutic index (e.g., Thioridazine, Flecainide, Propafenone) may require dose adjustment. Digoxin levels may increase, monitor digoxin levels.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may result in increased heart rate, palpitations, and increased blood pressure. Treatment should be symptomatic and supportive. Monitor vital signs and provide general supportive measures.
Pregnancy & Lactation
Pregnancy Category C. Use 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 nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2 to 3 years from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Patented (varies by region)
Clinical Trials
Mirabegron has been extensively studied in multiple phase 3 clinical trials demonstrating its efficacy and safety in patients with OAB symptoms.
Lab Monitoring
- Blood pressure monitoring, especially at baseline and periodically during treatment, particularly in patients with hypertension.
Doctor Notes
- Monitor blood pressure regularly, particularly in patients with known hypertension or those at risk of hypertension.
- Assess renal and hepatic function before initiating and periodically during treatment.
- Advise patients on lifestyle modifications and bladder training in conjunction with pharmacotherapy.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor.
- Inform your doctor about all other medications, including over-the-counter drugs, vitamins, and herbal supplements.
- Report any severe or persistent side effects to your doctor.
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 schedule. Do not double the dose to catch up.
Driving Precautions
Mirabegron has no or negligible influence on the ability to drive and use machines. However, if you experience dizziness, do not drive or operate machinery.
Lifestyle Advice
- Consider incorporating pelvic floor exercises and bladder training techniques.
- Maintain adequate fluid intake but avoid excessive fluids, especially before bedtime.
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