Mirabegrondrug info
24 HR mirabegron 8 MG/ML Extended Release Suspension
What it is used for
1 INDICATIONS & USAGE Mirabegron for extended-release oral suspension is a beta-3 adrenergic agonist indicated for the treatment of NDO in pediatric patients aged 3 years and older.
1.2 Pediatric
Neurogenic Detrusor Overactivity (NDO) Mirabegron for Extended-Release Oral Suspension Mirabegron for extended-release oral suspension is indicated for the treatment of NDO in pediatric patients aged 3 years and older.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 22, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Mirabegron for extended-release oral suspension are beta-3 adrenergic agonists. The chemical name of mirabegron is 2-(2-aminothiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2- phenylethyl]amino}ethyl)phenyl]acetamide having an molecular formula of C 21 H 24 N 4 O 2 S and a molecular weight of 396.51. The structural formula of mirabegron is: Mirabegron is a white to off white solid. It is soluble in methanol and dimethyl sulfoxide, practically insoluble in water. Each bottle of mirabegron for extended-release oral suspension contains approximately 8.3 g of granules, which contain 830 mg of mirabegron, and the following inactive ingredients: acesulfame potassium, colloidal silicon dioxide, ethyl paraben, hydrochloric acid, hypromellose, mannitol, methyl paraben, simethicone, sodium polystyrene sulfonate, talc, xanthan gum. After reconstituted with 100 mL water, the suspension contains 8 mg/mL of mirabegron. mirabegron-stru
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 22, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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