Miraflo
Generic Name
Mirabegron
Manufacturer
Astellas Pharma
Country
Japan
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| miraflo 25 mg tablet | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Miraflo (Mirabegron) is an extended-release tablet used to treat the symptoms of overactive bladder (OAB), such as urgent need to urinate, increased frequency of urination, and urinary incontinence. It works by relaxing the bladder muscle, allowing it to hold more urine.
Uses & Indications
Dosage
Adults
Recommended starting dose is 25 mg once daily. May be increased to 50 mg once daily based on efficacy and tolerability.
Elderly
No dosage adjustment is required based on age. However, caution should be exercised in elderly patients due to potential for increased exposure.
Renal_impairment
Mild renal impairment (CrCl 30-89 mL/min): No adjustment. Moderate renal impairment (CrCl 15-29 mL/min): Max dose 25 mg once daily. Severe renal impairment (CrCl < 15 mL/min) or ESRD: Not recommended.
How to Take
Miraflo tablets should be taken orally with water, once daily. They can be taken with or without food. The tablets must be swallowed whole and not chewed, crushed, or divided.
Mechanism of Action
Mirabegron is a beta-3 adrenergic agonist that stimulates beta-3 adrenergic receptors in the bladder, leading to relaxation of the detrusor muscle during the storage phase of the urinary bladder cycle. This increases bladder capacity without increasing voiding pressure.
Pharmacokinetics
Onset
Within 1-2 weeks for symptomatic improvement.
Excretion
Approximately 55% excreted in urine (25% as unchanged drug) and 34% in feces (50% as unchanged drug).
Half life
Approximately 32 hours.
Absorption
Absolute bioavailability is 29% for 25 mg and 37% for 50 mg. Tmax is approximately 3.5 hours for 25 mg and 4 hours for 50 mg. Food decreases Cmax and increases Tmax.
Metabolism
Primarily through CYP2D6 and CYP3A4, and also via non-CYP pathways (butylcholinesterase, 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).
Drug Interactions
Digoxin
Mirabegron increases digoxin exposure. Digoxin levels should be monitored.
Warfarin
No clinically significant interaction.
Drugs metabolized by CYP2D6
Mirabegron is a moderate CYP2D6 inhibitor. Dose adjustment may be required for narrow therapeutic index drugs like metoprolol, flecainide, propafenone, thioridazine.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. 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. ECG monitoring may be advisable.
Pregnancy & Lactation
Pregnancy Category C. 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. A decision should be made whether to discontinue nursing or to discontinue the drug.
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
Digoxin
Mirabegron increases digoxin exposure. Digoxin levels should be monitored.
Warfarin
No clinically significant interaction.
Drugs metabolized by CYP2D6
Mirabegron is a moderate CYP2D6 inhibitor. Dose adjustment may be required for narrow therapeutic index drugs like metoprolol, flecainide, propafenone, thioridazine.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. 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. ECG monitoring may be advisable.
Pregnancy & Lactation
Pregnancy Category C. 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. A decision should be made whether to discontinue nursing or to discontinue the drug.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Patent protected
Clinical Trials
Mirabegron has been extensively studied in multiple phase 3 trials (e.g., SYMPHONY, SCORPIO, BLOSSOM, and TAURUS studies) demonstrating its efficacy and safety in patients with OAB symptoms.
Lab Monitoring
- Blood pressure monitoring, especially in patients with pre-existing hypertension.
- Renal function monitoring in patients with renal impairment.
Doctor Notes
- Assess blood pressure before and during treatment.
- Consider the patient's cardiovascular risk profile.
- Monitor for signs of urinary retention, especially in patients with bladder outflow obstruction or those taking antimuscarinic drugs.
Patient Guidelines
- Take the tablet whole with water; do not chew, crush, or divide it.
- Take it once daily at approximately the same time each day.
- Inform your doctor about all other medications you are taking, especially blood pressure medications, digoxin, or other drugs metabolized by CYP2D6.
- Report any severe increase in blood pressure or heart rate to your doctor immediately.
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 two doses at the same time.
Driving Precautions
Miraflo is not expected to affect the ability to drive or operate machinery. However, dizziness has been reported as a common side effect, so caution should be advised.
Lifestyle Advice
- Maintain a healthy diet and regular exercise.
- Avoid excessive caffeine and alcohol, which can irritate the bladder.
- Practice bladder training techniques as advised by your doctor.
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