Prolonged-release tablet. Mirabegron is indictaed for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
ACTIVE: Mirabegron INACTIVE: polyethylene oxide, polyethylene glycol, hydroxypropyl cellulose, butylated hydroxytoluene, magnesium stearate, hypromellose, yellow ferric oxide and red ferric oxide (25 mg only)
The recommended dose is 50 mg once daily with or without food.The tablet is to be taken once daily, with liquids, swallowed whole and is not to be chewed, divided, or crushed. The safety and efficacy of mirabegron in children below 18 years of age have not yet been established.
Mirabegron has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) and, therefore, it is not recommended for use in patient population with renal impairment. Data are limited in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2),a dose reduction to 25 mg is recommended in this population. Mirabegron has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, it is not recommended for use in this patient population.
COMMON (>1/10): Urinary tract infection, Tachycardia, Nausea. UNCOMMON (>1/100 to <1/10):Vaginal infection, Cystitis, Palpitation, Dyspepsia, Gastritis, Urticaria, Rash, Pruritus, Joint swelling, Vulvovaginal pruritus,Blood pressure increased. RARE: Eyelid oedema, Lip oedema, Leukocytoclastic vasculitis, Purpura, Angioedema.
Product Code: 13162
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.