Miragon^®

Miragon® is a preparation of Mirabegron which is a beta-3 adrenergic agonist. Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder by activation of beta-3 adrenergic receptor which increases bladder capacity.

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Miragon® is indicated for the treatment of -

• Overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency as monotherapy and as combination therapy with solifenacin succinate.
• NDO in pediatric patients aged 3 years and older and weighing 35 kg or more

Route of administration: Miragon should be taken in oral route with or without food.

The recommened starting dose of Miragon is 25 mg once daily. Dose may be increased to 50 mg once daily after 4 to 8 weeks if necessary.

Hepatic impairment
In patients with moderate hepatic impairment (Child-Pugh Class B), the daily dose of Miragon® should not exceed 25 mg. Miragon® is not recommended in patients with severe hepatic impairment.

Renal impairment
In patients with severe renal impairment (eGFR 15 to 29 ml/min/1.73 m2), the daily dose of Miragon® should not exceed 25 mg. Miragon® is not recommended for patients requiring dialysis (eGFR <15 ml/min/1.73 m2).

Pregnancy:

There are no well controlled studies of pregnant women exposed to mirabegron of a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.\

Lactation:

There is no information regarding the presence of mirabegron in human milk, the effects on the breastfed infant or the effects on milk production.

Mirabegron can increase blood pressure thus it is not recommended for use in severe uncontrolled hypertensive patients. Administer with caution in patients with bladder outlet obstruction and in patients taking antimuscarinic drugs for overactive bladder.

Most common side effects are hypertension, nasopharyngitis, urinary tract infection, headache, dry mouth, constipation and tachycardia.

Mirabegron is contraindicated in patients with history of known hypersensitivity to mirabegron or any other components of this product.

Drug interaction with medication:

Proper monitoring and dose adjustment is required in concomitant use with drugs metabolized by CYP2D6 enzyme, digoxin and warfarin.

Drug interaction with food and others:

Not applicable.

In case of overdosage, general supportive measures and proper monitoring should be initiated.

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Miragon 25 tablet: Each prolonged release tablet contains Mirabegron BP 25 mg.
Miragon 50 tablet: Each prolonged release tablet contains Mirabegron BP 50 mg.

Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.

Packing
Miragon 25 tablet: Carton of 30 tablets in blister pack.
Miragon 50 tablet: Carton of 10 tablets in blister pack.