Lepixa 500/Lepixa 1000 Administer daily dose in 2 equally divided doses.
Monotherapy in adults & adolescents from 16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk & can be further increased by 250 mg bid every 2 wk. Max: 1,500 mg bid.
Add-on therapy in adults >18 yr & adolescents 12-17 yr & >50 kg Initially 500 mg bid which can be started on 1st day of treatment. Daily dose can be increased up to 1,500 mg bid. Dose changes can be made in 500 mg bid increases or decreases every 2-4 wk.
Childn 4-11 yr & adolescents 12-17 yr weighing <50 kg Initially 10 mg/kg bid, can be increased up to 30 mg/kg bid. Dose changes should not exceed increases or decreases of 10 mg/kg bid every 2 wk,
≥50 kg Same as adult dose.
Renal impairment CrCl >80 mL/min/1.73 m2 (normal) 500-1,500 mg bid,
50-79 mL/min/1.73 m2 (mild) 500-1,000 mg bid,
30-49 mL/min/1.73 m2 (moderate) 250-750 mg bid,
<30 mL/min/1.73 m2 (severe) 250-500 mg bid,
ESRD patients undergoing dialysis 500-1,000 mg once daily w/ recommended 750-mg loading dose on 1st day of treatment & 250-500-mg supplemental dose following dialysis.
Hepatic impairment CrCl <70 mL/min/1.73 m2 50% reduction of daily maintenance dose.
Lepixa oral soln Monotherapy for adult & adolescent 16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk. May further increase by 250 mg bid every 2 wk, max: 1,500 mg bid.
Add on therapy in adult 18 yr & adolescents (12-17 yr & weighing >50 kg) Initially 500 mg bid, daily dose can be increased up to 1,500 mg bid. Change of doses can be made in 500 mg bid increases or decreases every 2-4 wk.
Add on therapy in childn (2-11 yr) & adolescent (12-17 yr), infants 6-23 mth initially 10 mg/kg bid, may be increased up to 30 mg/kg bid. Dose should not exceed increases or decreases of 10 mg/kg bid every 2 wk.
≥50 kg dose is the same w/ adults;
from 50 kg 500 bid, max: 1,500 mg bid;
25 kg 250 mg bid, max: 750 mg bid;
25 kg 250 mg bid, max: 750 mg bid;
20 kg 200 mg bid, max: 600 mg bid;
15 kg 150 mg bid, max: 450 mg bid;
10 kg 100 bid, max: 300 mg bid;
6 kg 180 mg bid.
Add on therapy for infants from 1 mth to <6 mth 7 mg/kg bid, can be increased up to 21 mg/kg bid. Dose change should not exceed increase or decrease of 7 mg/kg bid.
Infants <6 mth Initially, 7 mg/kg bid, max: 21 mg/kg bid;
7 kg 49 mg bid, max: 147 mg bid;
5 kg 35 mg bid, max: 105 mg;
4 kg 28 mg bid, max: 84 mg bid.
Lepixa soln for inj Partial onset seizure Adult ≥16 yr Initially 1,000 mg daily given as bid dosing (500 mg bid). Additional dose increments may be given (1,000 mg daily every 2 wk) to max daily dose: 3,000 mg.
Childn 4-16 yr Initially 20 mg/kg daily in 2 divided doses (10 mg/kg bid), increased every 2 wk by increments of 20 mg/kg to recommended daily dose: 60 mg/kg (30 mg/kg bid). Max daily dose: 3,000 mg,
6 mth to <4 yr Initially 20 mg/kg daily in 2 divided doses (10 mg/kg bid), increased in 2 wk by increment of 20 mg/kg to recommended daily dose: 50 mg/kg (25 mg/kg bid),
1 mth to <6 mth Initially 14 mg/kg daily in 2 divided doses (7 mg/kg bid), increased every 2 wk by increments of 14 mg/kg to recommended daily dose: 42 mg/kg (21 mg/kg bid).
Myoclonic seizures w/ juvenile myoclonic epilepsy Initially 1,000 mg daily given as bid dosing (500 mg bid), increased by 1,000 mg daily every 2 wk to recommended daily dose: 3,000 mg.
Primary generalized tonic-clonic seizures Adult ≥16 yr Initially 1,000 mg daily given as bid dosing (500 mg bid), increased by 1,000 mg daily every 2 wk to recommended daily dose: 3,000 mg.
Childn 6-<16 yr Initially 20 mg/kg in 2 divided doses (10 mg/kg bid), increased every 2 wk by increments of 20 mg/kg (10 mg/kg bid) to recommended daily dose: 60 mg/kg (30 mg/kg bid).
Renal impairment in adult CrCl >80 mL/min/1.73 m2 (normal) 500-1,500 mg every 12 hr,
50-80 mL/min/1.73 m2 (mild) 500-1,000 mg every 12 hr,
30-50 mL/min/1.73 m2 (moderate) 250-750 mg every 12 hr,
<30 mL/min/1.73 m2 (severe) 250-500 mg every 12 hr,
ESRD patients using dialysis 500-1,000 mg every 24 hr w/ 250-500 mg-supplemental dose following dialysis.
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