Mirfine 25/50 mg

Composition

Mirfine 25/50 mg

Monotherapy

  • Indicated for overactive bladder (OAB) 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.

Combination With Muscarinic Antagonist

  • Indicated in combination with the muscarinic antagonist solifenacin succinate for treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.
  • Combination regimen: 25 mg PO qDay plus solifenacin succinate 5 mg PO qDay.
  • May increase mirabegron to 50 mg PO qDay after 4-8 weeks based on individual efficacy and tolerability.

Dosage Modifications

Renal Impairment

  • Mild-to-moderate (eGFR ≥30 mL/min/1.73 m2): No dosage adjustment required.
  • Severe (eGFR 15-29 mL/min/1.73 m2): Not to exceed 25 mg/day
  • eGFR <15mL/min/1.73 m2 or on dialysis: Not recommended.

Hepatic Impairment

  • Mild (Child-Pugh A): No dosage adjustment required.
  • Moderate (Child-Pugh B): Not to exceed 25 mg/day for either starting or maximum dose.
  • Severe (Child Pugh C): Not recommended.

Dosing Considerations

  • Granules and tablets are 2 different products and are not substitutable on a milligram-per-milligram basis.
  • Recommended dosage for granules in adults has not been determined.