Betmiga Prolonged Release F / C tablet
Mirabegron
50mg
SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO. LTD
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | SAUDI ARABIA |
| Agent | CITY MEDICAL STORE |
| Retail Price | 209.50 AED |
Indications
Betmiga Prolonged Release F / C tablet is used for:
Overactive bladder, with symptoms of urge urinary incontinence, urgency, and urinary frequency
Adult Dose
Overactive Bladder
Indicated for overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency
25 mg PO qDay
25 mg dose is typically effective within 8 weeks
May increase to 50 mg PO qDay based on individual efficacy and tolerability
Hepatic impairment
Moderate (Child-Pugh B): Not to exceed 25 mg/day
Severe (Child Pugh C): Not recommended
Child Dose
Renal Dose
Renal impairment
Severe (CrCl 15-29 mL/min): Not to exceed 25 mg/day
ESRD: Not recommended
Administration
May be taken with or without food: Swallow whole, do not chew/divide/crush.
Contra Indications
Hypersensitivity. Severe uncontrolled HTN.
Precautions
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
Pregnancy-Lactation
Pregnancy
There are no studies with the use in pregnant women to inform drug-associated risk for birth defects or miscarriage
Animal data
Administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via AUC) the maximum recommended human dose (MRHD) of 50 mg/day and decreased fetal body weights (in rabbits) at 14-fold the MRHD
At maternally toxic exposures in rats (96-fold), decreased fetal weight and increased fetal mortality were observed and, in rabbits (36-fold), cardiac findings (fetal cardiomegaly and fetal dilated aortae) were observed
Lactation
There is no information on the presence of mirabegron in human milk, the effects on the breastfed child, or the effects on milk production
Mirabegron-related material was present in rat milk and in the stomach of nursing pups following administrations of a single 10 mg/kg oral dose of 14C-labeled mirabegron to lactating rats
Interactions
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.
Adverse Effects
Side effects of Mirabegron :
>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
Mechanism of Action
Beta-3 adrenergic receptor agonist which causes relaxation of the detrusor smooth muscle of the urinary bladder and increases bladder capacity.
Note
Betmiga 50mg Prolonged Release F / C tablet manufactured by SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO. LTD. Its generic name is Mirabegron. Betmiga is availble in United Arab Emirates.
Farmaco UAE drug index information on Betmiga Prolonged Release F / C tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.