Active Substance: Mirabegron.
Overview
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This medicine contains an important and useful components, as it consists of
Mirabegronis available in the market in concentration
Mirabegron
End-stage renal disease, severe renal impairment; moderate (Child-Pugh Class B) & severe hepatic impairment (Child-Pugh Class C); severe uncontrolled HTN. Known history of QT prolongation or taking medicines known to prolong QT interval; bladder outlet obstruction & taking antimuscarinic medications for OAB. Women of childbearing potential not using contraception. Pregnancy & lactation. Childn <18 yr. Lactation: Unknown whether distributed in breast milk; excretion in breast milk possible; discontinue nursing or the drug taking into account the importance of the drug to the mother
Overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency
Hypersensitivity. Severe uncontrolled HTN.
>10% Elevated BP occurring predominantly in patients with preexisting hypertension (7-11%) 1-10% Dry mouth (3-9%),Nasopharyngitis (3-4%),UTI (3-6%),Headache (2-4%),Influenza (2-3%),Constipation (2-3%),Dizziness (2%),Arthralgia (2%),Cystitis (2%),Back pain (1-3%),Sinusitis (1-3%),URTI (1-2%),Arthralgia (1-2%),Diarrhea (1-2%),Tachycardia (1-2%),Fatigue (1%),Abdominal pain (0-1%),Reports of neoplasms (0-1%) <1% Cardiac disorders (eg, palpitations, elevated BP),Eye Disorders (eg, glaucoma, blurry vision),GI disorders (eg, dyspepsia, gastritis, abdominal distension),Rhinitis,Elevations in GGT, AST, ALT, LDH, Renal and urinary disorders (eg, nephrolithiasis, bladder pain), Reproductive system disorders (eg, vulvovaginal pruritis, vaginal infection) Skin and subcutaneous tissue disorders (eg, urticaria, leukocytoclastic vasculitis, rash, pruritus, purpura, lip edema) Stevens-Johnson syndrome associated with increased serum ALT, AST and bilirubin
3
Beta-3 adrenergic receptor agonist which causes relaxation of the detrusor smooth muscle of the urinary bladder and increases bladder capacity.
Increased AUC of strong CYP3A/P-gp inhibitors eg, ketoconazole, itraconazole, ritonavir, clarithromycin. Decreased plasma conc by CYP3A/P-gp inducers. Increased Cmax & AUC of metoprolol, despiramine & digoxin. Thioridazine, type 1C antiarrhythmics (eg flecainide, propafenone), TCAs. Potential P-gp inhibition of dabigatran.
Information not available