Miraba
Generic Name
Mirabegron
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| miraba 10 mg tablet | ৳ 35.00 | ৳ 350.00 |
Description
Overview of the medicine
Miraba 10 mg Tablet contains Mirabegron, a beta-3 adrenergic agonist. It is used to treat symptoms of overactive bladder (OAB), such as urinary urgency, increased frequency of urination, and urge incontinence. It works by relaxing the bladder muscle, increasing its capacity.
Uses & Indications
Dosage
Adults
The usual starting dose of Mirabegron is 25 mg once daily. The dose can be increased to 50 mg once daily based on individual patient response and tolerability. For a 10mg tablet, it may be used as an initial low dose or for patients with specific conditions, but higher doses are usually recommended for efficacy.
Elderly
No dosage adjustment is required for elderly patients based on age alone. However, renal and hepatic function should be assessed.
Renal_impairment
For severe renal impairment (CrCl 15 to 29 mL/min), the maximum dose is 25 mg once daily. Miraba 10 mg may be considered in these patients, though specific guidelines for 10mg are limited. Not recommended for end-stage renal disease or patients on hemodialysis.
How to Take
Take the tablet orally once daily with water. It can be taken with or without food. Swallow the tablet whole; do not chew, crush, or divide it.
Mechanism of Action
Mirabegron selectively activates beta-3 adrenergic receptors in the bladder, which leads to relaxation of the detrusor muscle during the storage phase of the bladder fill-void cycle. This relaxation increases bladder capacity and reduces the frequency of involuntary detrusor contractions.
Pharmacokinetics
Onset
Clinical effects usually seen within 2-8 weeks of initiation.
Excretion
Approximately 55% excreted renally (25% as unchanged drug) and 34% via feces.
Half life
Approximately 32 hours.
Absorption
Absolute bioavailability is 29-35%. Peak plasma concentrations (Tmax) are reached in approximately 3.5 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 blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg).
Drug Interactions
Digoxin
Mirabegron is a moderate CYP2D6 inhibitor. Digoxin levels may increase when co-administered with mirabegron. Monitor digoxin levels and adjust dose if necessary.
Warfarin
Although not a significant interaction, monitor INR more frequently when initiating mirabegron in patients on warfarin.
CYP2D6 substrates
Mirabegron may increase exposure to drugs primarily metabolized by CYP2D6 (e.g., flecainide, propafenone, metoprolol, desipramine). Dose adjustments may be necessary.
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 palpitations and increased pulse rate. In case of an overdose, symptomatic and supportive treatment should be initiated. ECG monitoring is recommended.
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 if mirabegron is excreted in human milk, so caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg).
Drug Interactions
Digoxin
Mirabegron is a moderate CYP2D6 inhibitor. Digoxin levels may increase when co-administered with mirabegron. Monitor digoxin levels and adjust dose if necessary.
Warfarin
Although not a significant interaction, monitor INR more frequently when initiating mirabegron in patients on warfarin.
CYP2D6 substrates
Mirabegron may increase exposure to drugs primarily metabolized by CYP2D6 (e.g., flecainide, propafenone, metoprolol, desipramine). Dose adjustments may be necessary.
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 palpitations and increased pulse rate. In case of an overdose, symptomatic and supportive treatment should be initiated. ECG monitoring is recommended.
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 if mirabegron is excreted in human milk, so caution should be exercised when administered to a nursing woman.
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 (local regulatory bodies)
Patent Status
Generic versions available in some regions
Clinical Trials
Mirabegron has been extensively studied in various clinical trials demonstrating its efficacy and safety in treating OAB symptoms.
Lab Monitoring
- Blood pressure monitoring, especially in patients with a history of hypertension.
Doctor Notes
- Assess patient for history of severe uncontrolled hypertension before initiating mirabegron.
- Advise patients about the potential for increased blood pressure or heart rate.
- Consider renal and hepatic function, especially for severe impairment when prescribing doses above 10mg or 25mg.
- Review concomitant medications, particularly those metabolized by CYP2D6 or having a narrow therapeutic index (e.g., digoxin).
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking Miraba without consulting your doctor, even if your symptoms improve.
- Report any sudden increase in blood pressure or heart rate to your doctor.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Mirabegron is not expected to affect the ability to drive or use machines. However, if you experience dizziness or blurred vision, avoid driving or operating machinery.
Lifestyle Advice
- Limit caffeine and alcohol intake, as they can irritate the bladder.
- Maintain a healthy weight, as obesity can worsen OAB symptoms.
- Practice bladder training techniques, such as timed voiding and delaying urination.
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