Miraba
Generic Name
Mirabegron
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| miraba 5 mg tablet | ৳ 20.00 | ৳ 200.00 |
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. It works by relaxing the detrusor muscle of the bladder, increasing its capacity to store urine.
Uses & Indications
Dosage
Adults
The usual starting dose for Mirabegron in adults with OAB is 25 mg once daily, which may be increased to 50 mg once daily. A 5 mg dose of Mirabegron is not typically used for the treatment of overactive bladder in adults. If prescribed at 5 mg, follow your doctor's specific instructions.
Elderly
No dose adjustment is required for elderly patients (≥65 years old).
Renal_impairment
Mild to moderate renal impairment (CrCl 15-89 mL/min): No dose adjustment. Severe renal impairment (CrCl 15-29 mL/min): Maximum dose 25 mg once daily. Not recommended in end-stage renal disease (CrCl <15 mL/min) or patients requiring hemodialysis.
Hepatic_impairment
Mild hepatic impairment (Child-Pugh Class A): No dose adjustment. Moderate hepatic impairment (Child-Pugh Class B): Maximum dose 25 mg once daily. Not recommended in severe hepatic impairment (Child-Pugh Class C).
How to Take
Take orally once daily with water. The tablet should be swallowed whole and not chewed, crushed, or divided. Can be taken with or without food.
Mechanism of Action
Mirabegron activates the beta-3 adrenergic receptors in the bladder, leading to relaxation of the detrusor smooth muscle during the urine storage phase. This increases bladder capacity without increasing voiding pressure, thereby alleviating OAB symptoms.
Pharmacokinetics
Onset
Clinical effects may be observed within a few weeks, with full effect achieved within 8 weeks.
Excretion
Approximately 55% of the administered dose is excreted in urine (25% unchanged) and 34% in feces (50-70% unchanged).
Half life
Approximately 32 hours (for 50 mg dose).
Absorption
Mirabegron is absorbed after oral administration, with peak plasma concentrations (Cmax) occurring at approximately 3.5 hours. Absolute bioavailability is 29% for a 25 mg dose and 37% for a 50 mg dose, increasing with dose. Food decreases Cmax and AUC slightly.
Metabolism
Primarily metabolized by CYP2D6 and CYP3A4, as well as by butyrylcholinesterase and uridine diphospho-glucuronosyltransferases (UGT).
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).
- End-stage renal disease (CrCl <15 mL/min or patients requiring hemodialysis).
- Severe hepatic impairment (Child-Pugh Class C).
Drug Interactions
Digoxin
Mirabegron is a moderate CYP2D6 inhibitor. Co-administration with Digoxin (a CYP2D6 substrate) may increase Digoxin exposure. Monitor Digoxin plasma levels and adjust dose as necessary.
Warfarin
No clinically significant interaction observed, but caution is advised with co-administration of warfarin and other narrow therapeutic index drugs.
Metoprolol, Desipramine
May increase exposure to these CYP2D6 substrates. Caution is advised.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include palpitations, increased pulse rate, and increased blood pressure. Treatment should be symptomatic and supportive. Monitor ECG and blood pressure.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy. Breastfeeding is not recommended as Mirabegron is excreted in milk in animals.
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).
- End-stage renal disease (CrCl <15 mL/min or patients requiring hemodialysis).
- Severe hepatic impairment (Child-Pugh Class C).
Drug Interactions
Digoxin
Mirabegron is a moderate CYP2D6 inhibitor. Co-administration with Digoxin (a CYP2D6 substrate) may increase Digoxin exposure. Monitor Digoxin plasma levels and adjust dose as necessary.
Warfarin
No clinically significant interaction observed, but caution is advised with co-administration of warfarin and other narrow therapeutic index drugs.
Metoprolol, Desipramine
May increase exposure to these CYP2D6 substrates. Caution is advised.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include palpitations, increased pulse rate, and increased blood pressure. Treatment should be symptomatic and supportive. Monitor ECG and blood pressure.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy. Breastfeeding is not recommended as Mirabegron is excreted in milk in animals.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Patented (original molecule), generics available
Clinical Trials
Mirabegron has been extensively studied in various clinical trials demonstrating its efficacy and safety in patients with OAB symptoms, including those who were intolerant to or had an inadequate response to anticholinergic agents. Trials have shown sustained efficacy over long-term use.
Lab Monitoring
- Blood pressure monitoring (especially in patients with pre-existing hypertension).
- Monitor renal function in patients with renal impairment.
Doctor Notes
- Mirabegron offers an alternative to anticholinergics for OAB treatment, particularly useful for patients experiencing dry mouth or other anticholinergic side effects.
- Monitor blood pressure at baseline and periodically during treatment.
- Advise patients to swallow the tablet whole to ensure proper extended-release kinetics.
Patient Guidelines
- Take the tablet whole, do not chew, crush, or divide it.
- Inform your doctor about all medicines you are taking, including over-the-counter drugs and herbal supplements.
- Do not stop taking the medicine without consulting your doctor.
- Monitor your blood pressure regularly as advised by your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember on the same day. Do not take two doses in one day. Continue with the next dose at the regular time.
Driving Precautions
Mirabegron is not expected to affect the ability to drive or operate machinery.
Lifestyle Advice
- Maintain a healthy fluid intake.
- Consider bladder training exercises.
- Avoid excessive caffeine and alcohol, which can irritate the bladder.
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