Fycompa

Perampanel

Partial-onset seizures w/ or w/o secondarily generalised seizures in patients ≥4 yr. Adjunctive treatment of primary generalised tonic-clonic seizures in patients ≥7 yr w/ idiopathic generalised epilepsy.

Monotherapy in partial onset seizures Adult & adolescent ≥12 yr Initially 2 mg once daily at bedtime, may be increased by 2 mg at ≥2 wk-interval. Maintenance dose: 4-8 mg once daily. May increase or decrease dose as necessary by ≤2 mg at ≥2 wk-interval. Max daily dose: 8 mg. Childn 4-11 yr weighing ≥30 kg Initially 2 mg once daily at bedtime, may be increased by 2 mg at ≥2 wk-interval. Maintenance dose: 4-8 mg once daily. May increase or decrease dose as necessary by ≤2 mg at ≥2 wk-interval. Max daily dose: 8 mg, 20 to <30 kg Initially 1 mg once daily at bedtime, may be increased by 1 mg at ≥2 wk-interval. Maintenance dose: 4-6 mg once daily. May increase or decrease dose as necessary by ≤1 mg at ≥2 wk-interval. Max daily dose: 6 mg, <20 kg Initially 1 mg once daily at bedtime, may be increased by 1 mg at ≥2 wk-interval. Maintenance dose: 2-4 mg once daily. May increase or decrease dose as necessary by ≤1 mg at ≥2 wk-interval. Max daily dose: 4 mg. Adjunctive therapy in partial onset seizures Adult & adolescent ≥12 yr Initially 2 mg daily, may be increased by 2-mg increment either wkly or every 2 wk as per t_½ consideration. Maintenance dose: 4-8 mg daily. May further increase dose by 2-mg increment daily to max daily dose of 12 mg. Childn 4-11 yr weighing ≥30 kg Initially 2 mg daily, may be increased by 2-mg increment either wkly or every 2 wk as per t_½ consideration. Maintenance dose: 4-8 mg daily. May further increase dose by 2-mg increment daily to max daily dose of 12 mg, 20 to <30 kg Initially 1 mg daily, may be increased by 1-mg increment either wkly or every 2 wk as per t_½ consideration. Maintenance dose: 4-6 mg daily. May further increase dose by 1-mg increment daily to max daily dose of 8 mg, <20 kg Initially 1 mg daily, may be increased by 1-mg increment either wkly or every 2 wk as per t_½ consideration. Maintenance dose: 2-4 mg daily. May further increase dose by 0.5-mg increment daily to max daily dose of 6 mg. Primary generalised tonic-clonic seizures Adult & adolescent ≥12 yr Initially 2 mg daily, may be increased by 2-mg increment either wkly or every 2 wk as per t_½ consideration. Maintenance dose: 8 mg daily. May further increase dose by 2-mg increment daily to max daily dose of 12 mg. Childn 7-11 yr weighing ≥30 kg Initially 2 mg daily, may be increased by 2-mg increment either wkly or every 2 wk as per t_½ consideration. Maintenance dose: 4-8 mg daily. May further increase dose by 2-mg increment daily to max daily dose of 12 mg, 20 to <30 kg Initially 1 mg daily, may be increased by 1-mg increment either wkly or every 2 wk as per t_½ consideration. Maintenance dose: 4-6 mg daily. May further increase dose by 1-mg increment daily to max daily dose of 8 mg, <20 kg Initially 1 mg daily, may be increased by 1-mg increment either wkly or every 2 wk as per t_½ consideration. Maintenance dose: 2-4 mg daily. May further increase dose by 0.5-mg increment daily to max daily dose of 6 mg. Patient taking concomitant medicinal products that do not shorten t_½ Titrate no more frequently than at 2-wk interval. Patient taking concomitant medicinal products that shorten t_½ Titrate no more frequently than at 1-wk interval. Mild or moderate hepatic impairment Initially 2 mg, may be up-titrated using 2 mg doses no faster than every 2 wk based on tolerability & effectiveness. Max: 8 mg.

May be taken with or without food. Tab: Swallow whole w/ a glass of water, do not chew/crush/split.

Hypersensitivity.

W/draw treatment immediately if signs & symptoms of DRESS or SJS appear. Not to restart treatment if patient develops serious reaction eg, SJS or DRESS. Consider discontinuation of treatment if symptoms of aggression & psychotic disorder are severe. Severe cutaneous adverse reactions; suicidal ideation & behaviour; aggressive, hostile & abnormal behaviours; homicidal ideation. Increased risk of falls particularly in the elderly. Patients w/ history of substance abuse. Monitor for signs of suicidal ideation & behaviours; skin reactions; symptoms of abuse; patients w/ myoclonic & absence seizures while on treatment; when switching from concomitant non-inducer anti-epileptic medicinal products to enzyme-inducing medicinal products & vice versa. Consider additional non-hormonal form of contraception during treatment. Monitor liver function if hepatic enzyme elevation is observed. Concomitant use w/ non-antiepileptic CYP450 inducers (eg, carbamazepine, phenytoin, oxcarbazepine) or inhibitors. May affect ability to drive & use machines. May cause hepatotoxicity in combination w/ other anti-epileptic drugs. Not recommended in moderate or severe renal impairment, patients undergoing haemodialysis, & severe hepatic impairment. Not recommended in women of childbearing potential not using contraception, & during pregnancy. Lactation. Childn <4 yr w/ partial-onset seizures; <7 yr w/ primary generalised tonic-clonic. Elderly. FC tab: Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Oral susp: Not to be taken by patients w/ hereditary fructose intolerance. Concomitant use w/ other antiepileptic medications containing sorbitol. May increase neonatal jaundice which may develop into kernicterus.

Dizziness, somnolence. Decreased/increased appetite; aggression, anger, anxiety, confusional state; ataxia, dysarthria, balance disorder, irritability; diplopia, blurred vision; vertigo; nausea; back pain; gait disturbance, fatigue; increased wt; fall. DRESS, SJS.

Decreased levonorgestrel mean C_max & AUC. Decreased C_max of ethinylestradiol. Decreased efficacy of hormonal progestative-containing contraceptives. Increased total clearance w/ carbamazepine, phenytoin or oxcarbazepine. Decreased oxcarbazepine clearance. Decreased midazolam AUC. Decreased conc w/ strong CYP450 inducers eg, rifampicin & hypericum. Reduced conc w/ felbamate. Increased AUC & prolonged t_½ w/ CYP3A4 inhibitor ketoconazole. Additive effects w/ alcohol & other CNS depressants.

Anticonvulsants

N03AX22 - perampanel ; Belongs to the class of other antiepileptics.

FC tab: S; Oral susp: D