Lanistor

Lamotrigine

Adjunctive or monotherapy treatment of partial & generalised seizures, including tonic-clonic seizures in adult & adolescent ≥13 yr. Seizures associated w/ Lennox-Gastaut syndrome as adjunctive therapy but may be the initial antiepileptic drug to start in adult & adolescent ≥13 yr w/ Lennox-Gastaut syndrome. Adjunctive treatment of partial & generalised seizures, including tonic-clonic seizures, & seizures associated w/ Lennox-Gastaut syndrome in childn & adolescent 2-12 yr. Monotherapy of typical absence seizures in childn & adolescent 2-12 yr. Prevention of depressive episodes in adult ≥18 yr w/ bipolar I disorder who experience predominantly depressive episodes.

Epilepsy Adult & adolescent ≥13 yr Monotherapy Wk 1 + 2: 25 mg once daily; Wk 3 + 4: 50 mg once daily. Maintenance: 100-200 mg/day once daily or in 2 divided doses. May increased by max of 50-100 mg every 1-2 wk until optimal response (500 mg/day) is achieved. Adjunctive therapy w/ valproate Wk 1 + 2: 12.5 mg daily given as 25 mg on alternate days; Wk 3 + 4: 25 mg once daily. Maintenance: 100-200 mg/day once daily or in 2 divided doses. May be increased by max of 25-50 mg every 1-2 wk until optimal response is achieved. Adjunctive therapy w/o valproate & w/ inducers of lamotrigine glucuronidation Wk 1 + 2: 50 mg once daily; Wk 3 + 4: 100 mg/day in 2 divided doses. Maintenance: 200-400 mg/day in 2 divided doses. May be increased by max of 100 mg every 1-2 wk until optimal response (700 mg/day) is achieved. Adjunctive therapy w/o valproate & w/o inducers of lamotrigine glucuronidation Wk 1 + 2: 25 mg once daily; Wk 3 + 4: 50 mg once daily. Maintenance: 100-200 mg/day once daily or in 2 divided doses. May be increased by max of 50-100 mg every 1-2 wk until optimal response is achieved. Childn & adolescent 2-12 yr Monotherapy of typical absence seizure Wk 1 + 2: 0.3 mg/kg once daily or in 2 divided doses; Wk 3 + 4: 0.6 mg/kg once daily or in 2 divided doses. Maintenance: 1-15 mg/kg/day once daily or in 2 divided doses. May be increased by max of 0.6 mg/kg/day every 1-2 wk until optimal response is achieved. Max: 200 mg/day. Adjunctive therapy w/ valproate Wk 1 + 2: 0.15 mg/kg once daily; Wk 3 + 4: 0.3 mg/kg once daily. Maintenance: 1-15 mg/kg/day once daily or in 2 divided doses. May be increased by max of 0.3 mg/kg/day every 1-2 wk until optimal response is achieved. Max: 200 mg/day. Adjunctive therapy w/o valproate & w/ inducers of lamotrigine glucuronidation Wk 1 + 2: 0.6 mg/kg/day in 2 divided doses; Wk 3 + 4: 1.2 mg/kg/day in 2 divided doses. Maintenance: 5-15 mg/kg/day once daily or in 2 divided doses. May be increased by max of 1.2 mg/kg/day every 1-2 wk until optimal response is achieved. Max: 400 mg/day. Adjunctive therapy w/o valproate & w/o inducers of lamotrigine glucuronidation Wk 1 + 2: 0.3 mg/kg once daily or in 2 divided doses; Wk 3 + 4: 0.6 mg/kg once daily or in 2 divided doses. Maintenance: 1-10 mg/kg/day once daily or in 2 divided doses. May be increased by max of 0.6 mg/kg/day every 1-2 wk until optimal response is achieved. Max: 200 mg/day. Bipolar disorder Adult ≥18 yr Monotherapy w/ lamotrigine or adjunctive therapy w/o valproate & w/o inducers of lamotrigine glucuronidation Wk 1 + 2: 25 mg once daily; Wk 3 + 4: 50 mg once daily or in 2 divided doses; Wk 5: 100 mg once daily or in 2 divided doses; Wk 6: 200 mg once daily or in 2 divided doses. Adjunctive therapy w/ valproate Wk 1 + 2: 12.5 mg daily given as 25 mg on alternate days; Wk 3 + 4: 25 mg once daily. Wk 5: 50 mg once daily or in 2 divided doses; Wk 6: 100 mg once daily or in 2 divided doses. Max: 200 mg/day. Adjunctive therapy w/o valproate & w/ inducers of lamotrigine glucuronidation Wk 1 + 2: 50 mg once daily; Wk 3 + 4: 100 mg in 2 divided doses; Wk 5: 200 mg in 2 divided doses; Wk 6: 300 mg in 2 divided doses. May be increased to 400 mg in 2 divided doses in wk 7 if necessary to achieve optimal response. Women taking hormonal contraceptives already taking maintenance doses & not taking inducers of lamotrigine glucuronidation Increase dose by 50-100 mg/day every wk. Stopping hormonal contraceptives in patient already taking maintenance doses & not taking inducers lamotrigine glucuronidation Gradually decrease daily dose by 50-100 mg each wk (at rate not exceeding 25% total daily dose/wk) over a period of 3 wk. Hepatic impairment Initial, escalation & maintenance doses should generally be reduced by approx 50% in moderate (Child-Pugh grade B) & 75% in severe (Child-Pugh grade C) hepatic impairment.

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

Hypersensitivity.

Not indicated for acute treatment of manic or depressive episodes. SJS, TEN, DRESS; hypersensitivity syndrome. History of rash or allergy to other antiepileptic drugs; suicidal behaviour or thoughts. Evaluate patients who develop rash promptly & w/draw treatment immediately unless the rash is clearly not related to treatment. Do not restart in patients who have discontinued due to rash or aseptic meningitis associated w/ prior treatment; have developed SJS, TEN or DRESS w/ the use of lamotrigine at any time. Photosensitivity reactions w/ high dose (≥400 mg), upon dose escalation or rapid up-titration; discontinue treatment if suspected in patient showing signs (eg, exaggerated sunburn). Avoid exposure to sunlight & artificial UV light & take protective measures (eg, use of protective clothing & sunscreens). Haemophagocytic lymphohistiocytosis. Suicidal ideation & behaviour. Possibility of interference w/ folate metabolism during long-term therapy. Abrupt w/drawal may provoke rebound seizures. Brugada syndrome. May worsen myoclonic seizures. Do not administer concurrently w/ any other prep containing lamotrigine w/o consulting a physician. Increased risk of suicidal thinking & behavior in childn & adolescent w/ major depressive & other psychiatric disorders. Women who are using contraception w/o pill-free wk, as 1st line therapy. May affect ability to drive & use machines. Patients w/ renal failure. Avoid sudden discontinuation in women who are childbearing potential or planning to become pregnant. Pregnancy & lactation. Not recommended for use in childn <2 yr.

Headache; skin rash. Aggression, irritability; somnolence, dizziness, tremor, insomnia, agitation; nausea, vomiting, diarrhoea, dry mouth; arthralgia; tiredness, pain, back pain.

Inhibited glucuronidation, reduced metabolism & increased mean t_½ w/ valproate. Induced glucuronidation w/ phenytoin, carbamazepine, phenobarb, primidone, rifampicin, lopinavir/ritonavir, ethinyloestradiol/levonorgestrel combination, atazanavir/ritonavir. Enhanced metabolism w/ certain antiepileptic drugs (eg, phenytoin, carbamazepine, phenobarb & primidone).

Anticonvulsants

N03AX09 - lamotrigine ; Belongs to the class of other antiepileptics.

Rx