M-BEG 25 - 25mg

Tablet

Pack Size : 10 Tablet x 1 Strip

Generics : Popular Pharmaceuticals Ltd.

Manufacturer : Popular Pharmaceuticals Ltd.

Best Price * TK 300.00

* Delivery will be done in Dhaka city only.

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More Information About - M-BEG 25 - 25mg

Description

Generic Name

Mirabegron

Precaution

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

Indication

Overactive bladder, with symptoms of urge urinary incontinence, urgency, and urinary frequency

Contra Indication

Hypersensitivity. Severe uncontrolled HTN.

Dose

N/A

Side Effect

>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

Pregnancy Category

Name : Not Classified

Description

FDA has not yet classified the drug into a specified pregnancy category.

Mode of Action

Beta-3 adrenergic receptor agonist which causes relaxation of the detrusor smooth muscle of the urinary bladder and increases bladder capacity.

Interaction

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.

Pregnancy Category Note

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

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

N/A

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.

Disclaimer

The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.