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.