Mirabegron


Concise Prescribing Info
Indications/Uses
Urinary incontinence, urgency and frequency.
Dosage/Direction for Use
Adult : PO Initial: 25 once daily, may increase to 50 mg once daily according to response.
Dosage Details
Oral
Urinary incontinence, urgency and frequency
Adult: Initially, 25 once daily; may increase to 50 mg once daily based on individual response and tolerance.
Renal Impairment
Haemodialysis patients: Contraindicated.
CrCl (mL/min) Dosage
<15 Contraindicated.
15-29 Max: 25 mg once daily. 
Hepatic Impairment
Moderate (Child-Pugh Class B): Max: 25 mg once daily. Severe (Child-Pugh Class C): Contraindicated.
Administration
Xr Tab: May be taken with or without food. Swallow whole, do not chew/crush/divide.
Contraindications
Severe uncontrolled HTN (systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg). Severe hepatic impairment, ESRD, or haemodialysis patients. Lactation. Patients taking concomitant strong CYP3A inhibitors who have moderate to severe hepatic or severe renal impairment.
Special Precautions
Patient w/ clinically significant bladder outlet obstruction, history of QT-interval prolongation, stage 2 HTN. Hepatic and renal impairment. Pregnancy.
Adverse Reactions
Significant: HTN.
Nervous: Headache, dizziness.
CV: Tachycardia, palpitations, AF.
GI: Constipation, diarrhea, nausea, dry mouth, abdominal pain or distension, dyspepsia, gastritis.
Resp: Nasopharyngitis, upper resp tract infection, sinusitis, rhinitis.
Genitourinary: UTI, bladder pain, nephrolithiasis, vag infection, vulvovaginal pruritus.
Musculoskeletal: Arthralgia.
Ophthalmologic: Glaucoma.
Dermatologic: Pruritus, rash, urticaria, purpura, leukocytoclastic vasculitis.
Others: Fatigue.
Potentially Fatal: Angioedema of the face, lips, tongue, and/or larynx.
MonitoringParameters
Monitor BP at baseline and regularly during therapy.
Overdosage
Symptoms: Palpitations, increased pulse rate and systolic BP. Management: Symptomatic and supportive treatment.
Drug Interactions
Increased exposure w/ strong CYP3A inhibitors (e.g. ketoconazole). May increase exposure to CYP2D6 substrates (e.g. desipramine, metoprolol), digoxin, and warfarin. Increased risk of urinary retention w/ antimuscarinic agents (e.g. solifenacin, darifenacin) due to additive pharmacologic effect.
Action
Description: Mirabegron relaxes detrusor smooth muscle in the bladder during the storage phase of micturition by selectively activating β3-adrenergic receptors, thereby increasing bladder capacity.
Onset: W/in 8 wk.
Pharmacokinetics:
Absorption: Bioavailability: 29-35%. Time to peak plasma concentration: Approx 3.5 hr.
Distribution: Widely distributed in the body, including erythrocytes. Plasma protein binding: Approx 71%, mainly to albumin and α1-acid glycoprotein.
Metabolism: Extensively metabolised via multiple pathways including dealkylation, oxidation, glucuronidation, and amide hydrolysis by multiple enzymes (e.g. butylcholinesterase, uridine diphospho-glucuronosyltransferase [UGT], CYP3A4, CYP2D6, and possibly by alcohol dehydrogenase) to form 2 major inactive metabolites.
Excretion: Via urine (55% as radiolabeled drug and approx 25% as unchanged drug) and faeces (34% as radiolabeled drug). Terminal elimination half-life: Approx 50 hr.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store at 25°C.
Any unused portions should be disposed of in accordance w/ local requirements.
ATC Classification
G04BD12 - mirabegron ; Belongs to the class of urinary antispasmodics.
Disclaimer: This information is independently developed by MIMS based on Mirabegron from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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