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Myrbetriq Granules Generic Name & Formulations
Legal Class
Rx
General Description
Mirabegron 8mg/mL; for ext-rel oral susp after reconstitution; contains mannitol.
Pharmacological Class
Beta-3 adrenergic agonist.
See Also
How Supplied
Tabs—30, 90; Granules—1
Manufacturer
Generic Availability
NO
Myrbetriq Granules Indications
Indications
Neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥3yrs.
Myrbetriq Granules Dosage and Administration
Adult
Not indicated.
Children
<3yrs: not established. Measure and dissolve granules with 100mL of water. Take with food once daily. ≥3yrs (11–<22kg): Initially 3mL (24mg), max 6mL (48mg); (22–<35kg): Initially 4mL (32mg), max 8mL (64mg); (≥35kg): Initially 6mL (48mg), may increase to max 10mL (80mg) after 4–8 weeks if needed. Severe renal impairment or moderate hepatic impairment: (11–<22kg): max 3mL (24mg); (22–<35kg): max 4mL (32mg); (≥35kg): max 6mL (48mg). ESRD, requiring dialysis, or severe hepatic impairment: not recommended.
Myrbetriq Granules Contraindications
Not Applicable
Myrbetriq Granules Boxed Warnings
Not Applicable
Myrbetriq Granules Warnings/Precautions
Warnings/Precautions
Do not substitute tabs and granules on a mg-per-mg basis. Severe uncontrolled hypertension: not recommended. Monitor blood pressure periodically. Significant bladder outlet obstruction, patients taking antimuscarinic drugs for OAB: risk of urinary retention. Discontinue and treat if angioedema of the tongue, hypopharynx, or larynx occurs. Pregnancy. Nursing mothers.
Myrbetriq Granules Pharmacokinetics
See Literature
Myrbetriq Granules Interactions
Interactions
May potentiate CYP2D6 substrates (eg, metoprolol, desipramine); adjust dose and monitor esp. with narrow therapeutic index drugs (eg, thioridazine, flecainide, propafenone). Concomitant digoxin: use lowest digoxin dose initially (monitor and titrate).
Myrbetriq Granules Adverse Reactions
Adverse Reactions
Adults: hypertension, nasopharyngitis, UTI, headache; also with solifenacin: dry mouth, constipation, tachycardia. Children: UTI, nasopharyngitis, constipation, headache.
Myrbetriq Granules Clinical Trials
See Literature
Myrbetriq Granules Note
Not Applicable
Myrbetriq Granules Patient Counseling
See Literature
