Adults

Initial dose: 5 mg once daily or 2.5 mg twice daily, increasing to 5 mg twice daily within a week, and then titrated up to a maximum of 15 mg twice daily based on individual response and tolerability. Administer with or without food.

Elderly

Start with a lower dose (e.g., 2.5 mg once daily or twice daily) and titrate slowly, considering potential age-related decrease in renal function.

Renal_impairment

Dose adjustment is necessary. For mild impairment (CrCl 60 to <90 mL/min): no adjustment needed. Moderate (CrCl 30 to <60 mL/min): halve the usual dose. Severe (CrCl <30 mL/min): quarter the usual dose.

Onset

Clinical effects may be observed within a few days to weeks, with full therapeutic effect often seen after dose titration.

Excretion

Primarily excreted renally (over 90% as unchanged drug) via glomerular filtration and active tubular secretion.

Half life

The elimination half-life is approximately 6 to 8 hours.

Absorption

Rapidly absorbed after oral administration, with peak plasma concentrations achieved within 1-2 hours. Bioavailability is high (approximately 85%).

Metabolism

Minimally metabolized; primarily eliminated as unchanged drug.

Other renally excreted drugs

As Mirogabalin is primarily renally excreted, concomitant use with other renally excreted drugs may theoretically alter their excretion, though clinical significance is generally low.

Central Nervous System (CNS) depressants

May enhance CNS depressant effects (e.g., somnolence, dizziness) when co-administered with alcohol, opioids, benzodiazepines, or other sedatives.