Julitam/Julitam I.V.

Levetiracetam

Julitam Tab: Monotherapy & adjunctive treatment of partial seizures w/ or w/o secondary generalization. Adjunctive therapy of myoclonic seizures & primarily generalized tonic-clonic seizures. Oral soln: Monotherapy in treatment of partial onset seizures w/ or w/o secondary generalisation in patients from 16 yr w/ newly diagnosed epilepsy. Adjunctive therapy in treatment of partial onset seizures w/ or w/o secondary generalisation in adults & childn from 1 mth w/ epilepsy; myoclonic seizures in adults & adolescents from 12 yr w/ juvenile myoclonic epilepsy; primary generalised tonic-clonic seizures in adults & adolescents from 12 yr w/ idiopathic generalised epilepsy. Julitam I.V. Monotherapy in the treatment of partial onset seizures w/ or w/o secondary generalization in adult & adolescent from 16 yr. As adjunctive therapy in the treatment of partial onset seizures w/ or w/o secondary generalization in adult & childn from 4 yr; treatment of myoclonic seizures in adult & adolescent from 12 yr w/ juvenile myoclonic epilepsy; treatment of primary generalized tonic-clonic seizures in adult & adolescent from 12 yr w/ idiopathic generalized epilepsy.

Julitam Tab Adult ≥16 yr Initially 1 g once daily or in 2 divided doses (500 mg bid). Thereafter, daily dose may be increased in increments of 1 g every 2-4 wk until effective antiepileptic control is achieved up to a max dose of 3 g daily. Childn >50 kg Adult dose, <50 kg 20 mg/kg once daily, may be increased in increments of 20 mg/kg every wk to a max dose of 60 mg/kg daily. Monotherapy 500 mg daily, may be increased after 2 wk to 1 g daily. Further increase may be made in increments of 500 mg every 2 wk up to max of 3 g daily. Oral Soln Monotherapy Adult & adolescent from 16 yr Initially 250 mg bid then increase to 500 mg bid after 2 wk. May further increase by 250 mg bid every 2 wk depending upon clinical response. Max: 1,500 mg bid. Add-on therapy Adult & adolescent (12-17 yr) weighing ≥50 kg 500 mg bid. Can be increased up to 1,500 mg bid. Dose may be changed in 500 mg increase or decrease every 2-4 wk. Adolescent 12-17 yr, childn 2-11 yr weighing <50 kg & infant 6-23 mth 10 mg/kg bid. May be increased up to 30 mg/kg bid. Dose changes should not exceed increase or decrease of 10 mg/kg bid every 2 wk. Childn weighing ≥50 kg Same as adult dose. Infant 1 mth-<6 mth 7 mg/kg bid. May be increased up to 21 mg/kg bid depending upon the clinical response & tolerability. Dose changes should not exceed increase or decrease of 7 mg/kg bid every 2 wk. CrCl <60 mL/min/1.73 m² 50% reduction of the daily maintenance dose. Julitam I.V. Monotherapy Adult & adolescent 16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk, may be further increased by 250 mg bid every 2 wk depending upon the clinical response. Max: 1,500 mg bid. Add on therapy Adult (≥18 yr) & adolescent weighing ≥50 kg (12-17 yr) Initially 500 mg bid, may be increased up to 1,500 bid. Dose changes (increase or decrease) can be made in 500 mg bid every 2-4 wk. Childn 4-11 yr & adolescent weighing <50 kg (12-17 yr) Initially 10 mg/kg bid. May be further increased up to 30 mg/kg bid. Max dose changes (increase or decrease): 10 mg/kg bid every 2 wk. Childn >50 kg Same as adult dose, from 50 kg 500 mg bid, max 1,500 kg 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.

May be taken with or without food: Oral soln: May be diluted in a glass of water.

Hypersensitivity to levetiracetam or other pyrrolidone derivatives.

Monitor for suicidal attempt/ideation/behavior. Renal insufficiency (may require dose adjustment). Avoid abrupt w/drawal. May impair ability to drive or operate machinery. Pregnancy & lactation. Infant & childn <4 yr. Julitam Tab: Infant & childn <6 yr. Oral soln: Hematologic/hepatic abnormalities. Should not be used in patients w/ rare hereditary problems of fructose intolerance. Julitam I.V. Perform CBC in patient experiencing weakness, pyrexia, recurrent infections or coagulation disorders. Patient on controlled Na diet.

Nasopharyngitis, somnolence, headache; anorexia, fatigue, dizziness, hostility, anxiety, insomnia, nervousness, irritability, depression, vertigo, diarrhea, vomiting. Asthenia; agitation. Julitam Tab: Personality disorder, emotional lability, mood swings, ataxia, seizures, amnesia, confusion, hypersomnia, increased reflexes, paresthesia, suicidal behavior. Pruritus, skin discoloration, vesiculobullous rash, alopecia. Rhinitis, pharyngitis, conjunctivitis, amblyopia, diplopia, ear pain. Gastroenteritis, constipation, pancreatitis. Albuminuria, urine abnormality. Ecchymosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia. Hepatic failure, hepatitis. Dehydration, wt loss. Neck pain. Increased cough, asthma, sinusitis. Accidental injury, infection, pain, flu &/or flu syndrome, face edema, viral infection. Oral soln: Postural dizziness. Emotional lability, headache in ped population. Julitam I.V. Aggression, convulsion, balance disorder, lethargy, tremor; cough, abdominal pain, dyspepsia, nausea; rash; asthenia.

Julitam Oral soln: Slightly reduced rate of absorption w/ food. Julitam I.V. Decreased MTX clearance resulting in increased MTX conc.

Anticonvulsants

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

Rx