Adults

Initial dose: 5 mg twice daily. May be increased after at least one week to 10 mg twice daily. Maximum recommended dose is 15 mg twice daily (30 mg/day), but doses up to 30 mg twice daily (60 mg/day) have been used in some studies/regions.

Elderly

No specific dose adjustment based on age alone, but renal function should be assessed and dose adjusted if needed.

Renal_impairment

Dose adjustment is required. For moderate renal impairment (CrCl 30 to <60 mL/min), reduce dose by half. For severe renal impairment (CrCl <30 mL/min) or end-stage renal disease, further dose reduction is necessary (e.g., 2.5 mg once daily or every other day).

Onset

Therapeutic effects may begin within a few days to a week, with full effect often seen after 2-4 weeks of consistent use.

Excretion

Primarily excreted unchanged in the urine, with approximately 90% of the administered dose recovered in urine within 24 hours. Renal clearance is directly proportional to creatinine clearance.

Half life

Approximately 2.9 to 3.8 hours.

Absorption

Rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations reached within 1-2 hours. Bioavailability is high, around 85%. Food does not significantly affect absorption.

Metabolism

Minimally metabolized; less than 5% undergoes hepatic metabolism. The primary route of elimination is renal excretion of unchanged drug.

Antacids

May slightly decrease Mirogabalin absorption, but generally not clinically significant. Administer Mirogabalin 2 hours before or after antacids if concern exists.

CNS Depressants (e.g., alcohol, opioids, benzodiazepines)

Increased risk of central nervous system (CNS) depression, including sedation and respiratory depression. Concomitant use should be with caution.