Acode 50/Acode 100

Monotherapy of partial-onset seizures in patients ≥16 yr w/ epilepsy. Adjunctive therapy in the treatment of partial-onset seizures w/ or w/o secondary generalization in patients ≥16 yr w/ epilepsy.

Adult ≥16 yr Monotherapy Initially 100 mg bid, increased to 150 mg bid after 1 wk. Can be further increased at wkly interval by 50 mg bid depending on response & tolerability up to max recommended maintenance daily dose 200 mg bid. Adjunctive therapy Initially 50 mg bid, increased to 100 mg bid after 1 wk. Maintenance dose can be further increased by 50 mg bid every wk up to max recommended daily dose 400 mg (200 mg bid). Initiation w/ loading dose (eg, for adjunctive therapy, initial monotherapy & conversion to monotherapy) Treatment may be initiated w/ single loading dose of 200 mg followed by 100 mg bid maintenance dose approx 12 hr later. Maintenance dose can be further increased by 50 mg bid every wk up to max recommended daily dose 400 mg (200 mg bid). Patient w/ severe renal impairment (CrCl ≤30 mL/min), ESRD or mild to moderate hepatic impairment Max dose: 300 mg daily. Patient requiring haemodialysis Consider a supplement up to 50% of the divided daily dose directly after end of haemodialysis.

May be taken with or without food.

Hypersensitivity.

Gradually taper daily dose (eg, by 200 mg wkly) if treatment has to be discontinued. Use has been associated w/ dizziness which could increase occurrence of accidental injury or falls. PR interval prolongations have been observed in clinical studies; caution in patients w/ known conduction problems or severe cardiac disease eg, history of MI or heart failure. Post-marketing reports of 2nd degree or higher AV block. Reports of suicidal ideation & behavior. Monitor for signs of suicidal ideation & behaviors & consider appropriate treatment. Minor to moderate influence on the ability to drive & use machines. Patients w/ severe renal impairment (CrCl ≤30 mL/min), ESRD; hepatic impairment. Should not be used during pregnancy unless clearly necessary. Discontinue nursing or discontinue therapy taking into account the drug's importance to the mother. Not recommended in childn & adolescents <16 yr. Limited experience in elderly w/ epilepsy.

Dizziness, headache; diplopia; nausea. Depression, confusional state, insomnia; cognitive disorder, nystagmus, balance disorder, abnormal coordination, memory impairment, tremor, somnolence, dysarthria, disturbance in attention, hypoesthesia, paresthesia; blurred vision; vertigo, tinnitus; vomiting, constipation, flatulence, dyspepsia, dry mouth, diarrhea; pruritus; muscle spasms; gait disturbance, asthenia, fatigue, irritability, feeling drunk; fall, skin laceration, confusion.

Caution w/ concomitant use w/ medicinal products associated w/ PR prolongation (eg, carbamazepine, lamotrigine, pregabalin) or class I antiarrhythmic drugs. Decreased overall systemic exposure w/ other anti-epileptics known to be enzyme inducers (carbamazepine, phenytoin, phenobarb, in various doses).

Anticonvulsants

N03AX18 - lacosamide ; Belongs to the class of other antiepileptics.

Rx