Information about ADMIRA
Each film coated extended-release tablet contains: 25 or 50 mg mirabegron.
Mechanism of Action:
Mirabegron is a potent and selective beta 3-adrenoceptor agonist.
Admira is used for Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
Mirabegron is contraindicated in patients with:
- Hypersensitivity to the active substance or to any excipients.
- Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg.
Warnings and Precautions:
Renal impairment: It is not recommended for use in patient with end stage renal disease (GFR < 15 mL/min/1.73 m2), and in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors.
Hepatic impairment: It is not recommended for use in patient with severe hepatic impairment, and in patients with moderate hepatic impairment concomitantly receiving strong CYP3A inhibitors.
Hypertension: Blood pressure should be measured periodically during treatment with Mirabegron, especially in hypertensive patients.
Patients with congenital or acquired QT prolongation: Caution should be exercised when administering mirabegron in these patients.
Patients with bladder outlet obstruction (BOO) and patients taking antimuscarinics medications for Overactive Bladder (OAB): Mirabegron should be administered with caution to patients with clinically significant (BOO), and to patients taking antimuscarinic medications for the treatment of (OAB).
Mirabegron are not recommended during pregnancy and in women of childbearing potential not using contraception.
Mirabegron should not be administered during breast-feeding.
Common: Urinary tract infection, Tachycardia, Nausea.
Uncommon: Vaginal infection, Cystitis, Palpitation, Atrial fibrillation, Dyspepsia, Gastritis, Urticaria, Rash, Rash macular, Rash papular, Pruritus, Joint swelling, Vulvovaginal pruritus, Blood pressure increased, GGT increased, AST increased, ALT increased.
The recommended dose is 50 mg once daily with or without food.
Method of administration:
The tablet is to be taken once daily, with liquids, swallowed whole and is not to be chewed, divided, or crushed.
Treatment for overdose should be symptomatic and supportive. In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended.
Store at 25°C.
Pack of 20 film coated extended-release tablets for both strengths.