Leveget

Levetiracetam

FC tab: As monotherapy in partial onset seizures w/ or w/o secondary generalization in adults & adolescents from 16 yr w/ newly diagnosed epilepsy. As adjunctive therapy in partial onset seizures w/ or w/o secondary generalization in adults, adolescents & childn ≥6 yr w/ epilepsy; myoclonic seizures in adults & adolescents from 12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults & adolescents from 6 yr w/ idiopathic generalized epilepsy. Soln for inj: Adjunctive therapy in partial onset seizures in adults & childn ≥1 mth w/ epilepsy; myoclonic seizures in adults & adolescents ≥12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults & childn ≥6 yr w/ idiopathic generalized epilepsy.

FC tab Monotherapy Adult & adolescent from 16 yr Initially 250 mg bid, should be increased to initial therapeutic dose of 500 mg bid after 2 wk. May further increased by 250 bid every 2 wk depending upon clinical response. Max: 1,500 mg bid. Add-on therapy Adults ≥18 yr & adolescent 12-17 yr weighing ≥50 kg Initially 500 mg bid. May be increased up to 1,500 mg bid depending upon clinical response & tolerability. Dose changes can be made in 500 mg bid increases or decreases every 2-4 wk. Adolescent 12-17 yr & childn 6-11 yr weighing ≥50 kg Adult dose, 25 kg Initially 250 mg bid. Max: 750 mg bid. Partial onset seizures Adult ≥16 yr Initially 1 g daily (given as 500 mg bid). Additional dosing of 1 g daily every 2 wk may be given. Max: 3 g daily. Ped patient 6-<16 yr Initially 20 mg/kg daily in 2 divided doses (10 mg/kg bid). Increase the daily dose every 2 wk by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg daily (30 mg/kg bid). Max: 3 g daily; >40 kg Initially 1 g daily (given as 500 mg bid). Increase daily dose every 2 wk by increments of 1 g daily. Max: 3 g daily (1,500 mg bid); 20-40 kg Initially 500 mg daily (given as 250 mg bid). Increase daily dose every 2 wk by increments of 500 mg. Max: 1,500 mg daily (750 mg bid). Myoclonic seizures Patient ≥12 yr w/ juvenile myoclonic epilepsy Initially 1 g daily (given as 500 mg bid). Increase dosage by 1 g daily every 2 wk to the recommended daily dose of 3 g. Primary generalized tonic-clonic seizures Adult ≥16 yr Initially 1 g daily (given as 500 mg bid). Increase dosage by 1 g daily every 2 wk to the recommended daily dose of 3 g. Ped patient 6-<16 yr Initially 20 mg/kg daily in 2 divided doses (10 mg/kg bid). Increase daily dose every 2 wk by increments of 20 mg/kg to recommended daily dose of 60 mg/kg (30 mg/kg bid). Discontinuation Adult & adolescent >50 kg 500 mg decreases bid every 2-4 wk; childn & adolescent <50 kg Dose decrease should not exceed 10 mg/kg bid every 2 wk. Adult & adolescent renal impairment CrCl >80 mL/min/1.73 m² 500-1,500 mg bid, 50-79 mL/min/1.73 m² 500 mg-1 g bid, 30-49 mL/min/1.73 m² 250-750 mg bid, <30 mL/min/1.73 m² 250-500 mg bid, ESRD patient undergoing dialysis 500 mg-1 g once daily, w/ 750 mg loading dose on the 1st day of treatment & 250-500 mg supplemental dose following dialysis. Childn & adolescent <50 kg renal impairment CrCl >80 mL/min/1.73 m² 10-30 mg/kg bid, 50-79 mL/min/1.73 m² 10-20 mg/kg bid, 30-49 mL/min/1.73 m² 5-15 mg/kg bid, <30 mL/min/1.73 m² 5-10 mg/kg bid, ESRD patient undergoing dialysis 10-20 mg/kg once daily, w/ 5-10 mg/kg supplemental dose following dialysis. Severe hepatic impairment 50% reduction of daily maintenance dose when CrCl is <60 mL/min/1.73 m². Soln for inj Partial onset seizures Adult ≥16 yr Initially 1,000 mg daily (given as 500 mg bid). Additional increments of 1,000 mg daily additional every 2 wk may be given. Max: 3,000 mg daily. Ped patient 4-<16 yr Initially 20 mg/kg daily in 2 divided doses (10 mg/kg bid). Increase daily dose every 2 wk by increments of 20 mg/kg to recommended daily dose of 60 mg/kg (30 mg/kg bid). Max: 3,000 mg daily; 6 mth-<4 yr Initially daily dose of 20 mg/kg in 2 divided doses (10 mg/kg bid). Increase daily dose in 2 wk by an increment of 20 mg/kg to recommended daily dose of 50 mg/kg (25 mg/kg bid); 1-<6 mth Initially 14 mg/kg in 2 divided doses (7 mg/kg bid). Increase daily dose every 2 wk by increments of 14 mg/kg to recommended daily dose of 42 mg/kg (21 mg/kg bid). Myoclonic seizures w/ juvenile myoclonic epilepsy Initially 1,000 mg daily (given as 500 mg bid). Increase dosage by 1,000 mg daily every 2 wk to recommended daily dose of 3,000 mg. Primary generalized tonic-clonic seizures Adult ≥16 yr Initially 1,000 mg daily (given as 500 mg bid). Increase dosage by 1,000 mg daily every 2 wk to recommended daily dose of 3,000 mg. Ped patient 6-<16 yr Initially 20 mg/kg daily in 2 divided doses (10 mg/kg bid). Increase daily dose every 2 wk by increments of 20 mg/kg (10 mg/kg bid) to recommended daily dose of 60 mg/kg (30 mg/kg bid). Adult renal impairment CrCl >80 mL/min/1.73 m² 500-1,500 mg every 12 hr, 50-80 mL/min/1.73 m² 500-1,000 mg every 12 hr, 30-50 mL/min/1.73 m² 250-750 mg every 12 hr, <30 mL/min/1.73 m² 250-500 every 12 hr, ESRD patients using dialysis 500-1,000 mg every 24 hr w/ 250-500 mg supplemental dose following dialysis.

May be taken with or without food: Swallow whole, do not chew or crush.

Hypersensitivity to other pyrrolidine derivatives.

Advise CBC counts in patients experiencing significant weakness, pyrexia, recurrent infections or coagulation disorders. Increased risk of suicidal thoughts or behavior. Monitor patients treated w/ any anti-epileptic drug for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, &/or any unusual changes in mood or behavior. May cause anaphylaxis or angioedema after 1st dose or any time during treatment. Discontinue at the 1st sign of rash, do not resume use & consider alternative therapy if signs or symptoms suggest SJS/TEN. Gradually w/draw antiepileptic drugs to minimize potential of increased seizure frequency. Monitor for somnolence, fatigue, coordination difficulties & advise patients not to drive or operate machinery until sufficient experience to gauge adverse effects was gained. Renal &/or hepatic impairment. May gradually decrease plasma levels throughout pregnancy. Close monitoring through post-partum period especially if dose was changed during pregnancy. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Childn. FC tab: Acute kidney injury. Soln for inj: Patients on a controlled Na diet.

Nasopharyngitis; somnolence, headache. Anorexia; depression, hostility/aggression, anxiety, insomnia, nervousness/irritability; convulsion, balance disorder, dizziness, lethargy, tremor; vertigo; cough; abdominal pain, diarrhoea, dyspepsia, vomiting, nausea; rash; asthenia/fatigue.

Decreased in renal clearance w/ probenecid. Decreased MTX clearance resulting in increased/prolonged blood MTX conc to potentially toxic levels. FC tab: Decreased efficacy w/ osmotic laxative macrogol.

Anticonvulsants

N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.

Rx