Information about ADMIRA

The composition: 
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.
Indications:
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. 
Contraindications:
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).
Pregnancy:
Mirabegron are not recommended during pregnancy and in women of childbearing potential not using contraception.
Lactation:
Mirabegron should not be administered during breast-feeding.
Side Effects:
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.
Dosage: 
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.
Overdosage Treatment: 
Treatment for overdose should be symptomatic and supportive. In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended.
Storage Conditions: 
Store at 25°C.
Packaging: 
Pack of 20 film coated extended-release tablets for both strengths.