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.

Partial-onset seizure Adult, adolescent ≥12 yr & childn 4-11 yr weighing ≥30 kg Initially 2 mg daily, may be increased by increment of 2 mg either wkly or every 2 wk to maintenance dose: 4-8 mg daily. May be further increased by increment of 2-12 mg daily if 8 mg daily is tolerated. Max: 12 mg daily, 20-<30 kg Initially 1 mg daily, may be increased by increment of 1 mg either wkly or every 2 wk to maintenance dose: 4-6 mg daily. May be further increased by increment of 1-8 mg daily if 6 mg daily is tolerated Max: 8 mg daily, <20 kg Initially 1 mg daily, may be increased by increment of 1 mg either wkly or every 2 wk to maintenance dose: 2-4 mg daily. May be further increased by increment of 0.5-6 mg daily if 4 mg daily is tolerated. Max: 6 mg daily. Primary generalised tonic-clonic seizure Adult & adolescent ≥12 yr Initially 2 mg daily, may be increased by increment of 2 mg either wkly or every 2 wk to maintenance dose: up to 8 mg daily. May be further increased up to 12 mg daily if 8 mg daily is tolerated. Max: 12 mg daily. Childn 7-11 yr weighing ≥30 kg Initially 2 mg daily, may be increased by increment of 2 mg either wkly or every 2 wk to maintenance dose: 4-8 mg daily. May be further increased by increment of 2-12 mg daily if 8 mg daily is tolerated. Max: 12 mg daily, 20-<30 kg Initially 1 mg daily, may be increased by increment of 1 mg either wkly or every 2 wk to maintenance dose: 4-6 mg daily. May be further increased by increment of 1-8 mg daily if 6 mg daily is tolerated Max: 8 mg daily, <20 kg Initially 1 mg daily, may be increased by increment of 1 mg either wkly or every 2 wk to maintenance dose: 2-4 mg daily. May be further increased by increment of 0.5-6 mg daily if 4 mg daily is tolerated. Max: 6 mg daily. Patient w/ mild or moderate hepatic impairment Initially 2 mg, up-titrate using 2 mg dose no faster than every 2 wk. Max: 8 mg.

May be taken with or without food: FC tab: Swallow whole, do not chew/crush/split. Oral susp: Take as single oral dose at bedtime. Use the provided adapter & graduated oral dosing syringe to administer the oral susp.

Hypersensitivity.

Discontinue if severe changes in mood or patterns of behavior occur; signs & symptoms suggestive of severe cutaneous ARs including DRESS & SJS appear. Monitor for signs of suicidal ideation & behaviors. Increased risk of falls particularly in the elderly. Patients w/ history of substance abuse; absence & myoclonic seizures. Concomitant use w/ progestative-containing hormonal contraceptives; CYP3A-inducing anti-epileptics eg, carbamazepine, phenytoin, oxcarbazepine; other (non-anti-epileptic) cytochrome P450 inducers or inhibitors. Not recommended in moderate or severe renal impairment or hemodialysis; severe hepatic impairment. Hepatotoxicity (mainly increased hepatic enzyme) in combination w/ other antiepileptics. May cause dizziness & somnolence & therefore may influence ability to drive or use machines. Not recommended in women of childbearing potential not using contraception & during pregnancy. Lactation. Childn <4 yr (w/ partial-onset seizures) or <7 yr (w/ primary generalised tonic-clonic seizures). Elderly ≥65 yr. FC tab: Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Oral susp: Contains sorbitol; not to be taken by patients w/ rare hereditary problems of fructose intolerance. Concomitant use w/ other antiepileptic medications containing sorbitol. Contains benzoic acid & Na benzoate which can displace bilirubin from albumin. Increase in bilirubinaemia following its displacement from albumin 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.

Possible decreased efficacy of progestative-containing OCs. Decreased conc w/ carbamazepine, oxcarbazepine, phenobarb, phenytoin, topiramate; strong cytochrome P450 inducers eg, rifampicin & Hypericum. Decreased clearance of oxcarbazepine. Decreased AUC of midazolam. Conc may be decreased w/ felbamate. Increased AUC & prolonged t_½ w/ CYP3A4 inhibitor eg, ketoconazole. Additive or supra-additive effects w/ alcohol (on tasks involving alertness & vigilance eg, driving ability).

Anticonvulsants

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

Rx