Mirabegron INN

Composition : Iragon : Each extended release film coated tablet contains Mirabegron INN 25mg.

Indications : 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.

Dosage and administration : The recommended starting dose is 25 mg once daily with or without food. It is effective within 8 weeks. Based on individual efficacy and tolerability the dose may be increased to 50 mg once daily. It should be taken with water, swallowed whole and should not be chewed, divided, or crushed. Patients with severe renal impairment or patients with moderate hepatic impairment : Maximum dose is 25 mg once daily. Patients with end stage renal disease (ESRD) or patients with severe hepatic impairment : not recommended. Or, as directed by the registered physician.

Use in pregnancy and lactation : Pregnancy Category C. There are no adequate and well-controlled studies using in pregnant women. It should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the fetus. It is not known whether this tablet is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Packing : Iragon : Each box contains 2 x 14's tablets in a blister pack.

Prescribing Description

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