Lamictal

Lamictal

lamotrigine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Concise Prescribing Info
Contents
Lamotrigine
Indications/Uses
Adjunct or monotherapy in the treatment of epilepsy, partial & generalized seizures including tonic-clonic seizures & seizures associated w/ Lennox-Gastaut syndrome in adults >12 yr & childn 2-12 yr. After epileptic control during adjunctive therapy in childn 2-12 yr, concomitant antiepileptic drugs may be w/drawn & patients continued on Lamictal therapy. Monotherapy in typical absence seizures in childn 2-12 yr. Prevention of mood episodes in patients w/ bipolar disorder in adults ≥18 yr.
Dosage/Direction for Use
Epilepsy Adult >12 yr Monotherapy Initially 25 mg once daily for 2 wk, followed by 50 mg once daily for 2 wk. Increase dose by max 50-100 mg every 1-2 wk. Maintenance: 100-200 mg/day once daily or as 2 divided doses up to 500 mg/day. Add-on therapy w/ valproate Initially 25 mg every alternate day for 2 wk, followed by 25 mg once daily for 2 wk. Increase dose by max 25-50 mg every 1-2 wk. Maintenance: 100-200 mg/day once daily or in 2 divided doses. Patient taking concomitant antiepileptic drugs (AEDs) or other medications that induce lamotrigine glucuronidation w/ or w/o other AEDs (except valproate) Initially 50 mg once daily for 2 wk, followed by 100 mg/day in 2 divided doses for 2 wk. Increase dose by max 100 mg every 1-2 wk. Maintenance: 200-400 mg/day in 2 divided doses up to 700 mg/day. Patient taking other medications that do not significantly inhibit/induce lamotrigine glucuronidation Initially 25 mg once daily for 2 wk followed by 50 mg once daily for 2 wk. Increase dose by max 50-100 mg every 1-2 wk. Maintenance: 100-200 mg/day or in 2 divided doses. Childn 2-12 yr Monotherapy (in typical absence seizure) Initially 0.3 mg/kg once daily or in 2 divided doses for 2 wk, followed by 0.6 mg/kg once daily or in 2 divided doses for 2 wk. Thereafter, increase dose by max 0.6 mg/kg 1-2 wkly. Maintenance: 1-10 mg/kg once daily or in 2 divided doses. Add-on therapy w/ valproate Initially 0.15 mg/kg/day for 2 wk, followed by 0.3 mg/kg once daily for 2 wk. Thereafter, increase dose by max 0.3 mg/kg every 1-2 wk. Maintenance: 1-5 mg/kg once daily or in 2 divided doses. Max: 200 mg/day. Patient taking concomitant AEDs or other medications that induce lamotrigine glucuronidation w/ or w/o other AEDs (except valproate) Initially 0.6 mg/kg/day in 2 divided doses for 2 wk, followed by 1.2 mg/kg/day in 2 divided doses for 2 wk. Thereafter, increase dose by max 1.2 mg/kg every 1-2 wk. Maintenance: 5-15 mg/kg/day in 2 divided doses. Max: 400 mg/day. Patient taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation Initially 0.3 mg/kg once daily or in 2 divided doses for 2 wk, followed by 0.6 mg/kg once daily or in 2 divided doses for 2 wk. Thereafter, increase dose by max 0.6 mg/kg every 1-2 wk. Maintenance: 1-10 mg/kg once daily or in 2 divided doses. Max: 200 mg/day. Bipolar disorder Adult ≥18 yr Adjunct therapy w/ lamotrigine glucuronidation inhibitors eg, valproate Initially 25 mg every alternate day for 2 wk, followed by 25 mg once daily for 2 wk. Increase dose to 50 mg once daily or in 2 divided doses for 1 wk. Optimal response is achieved w/ 100 mg once daily or in 2 divided doses. Max: 200 mg daily. Adjunct therapy w/ lamotrigine glucuronidation inducers in patient not taking inhibitors eg, valproate (should be used w/ phenytoin, carbamazepine, phenobarb, primidone & other drugs known to induce lamotrigine glucuronidation) Initially 50 mg once daily for 2 wk, followed by 100 mg/day in 2 divided doses for 2 wk. Increase dose to 200 mg/day in 2 divided doses for 1 wk. May be increased further to 300 mg/day for 1 wk to optimal response of 400 mg/day in 2 divided doses for succeeding wk. Monotherapy or adjunctive therapy w/ other medications that do not significantly induce/inhibit lamotrigine glucuronidation Initially 25 mg once daily for 2 wk, followed by 50 mg once daily or in 2 divided doses for 2 wk. Increase dose to 100 mg/day for 1 wk. Optimal response achieved w/ 200 mg/day or in 2 divided doses. Women taking hormonal contraceptives already taking maintenance doses & not taking lamotrigine glucuronidation inducers Increased by 50-100 mg/day every wk. Stopping hormonal contraceptives in patient already taking maintenance doses & not taking lamotrigine glucuronidation inducers 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 be generally reduced by approx 50% in moderate (Child-Pugh grade B) & 75% in severe (Child-Pugh grade C) impairment.
Administration
May be taken with or without food. Tab: Swallow whole, do not chew/crush. Dispersible/chewable tab: Chew, disperse in a small vol of water or swallow whole w/ a little water.
Contraindications
Special Precautions
Avoid reinitiation of therapy to patients who have discontinued treatment due to rash. History of allergy or rash to other antiepileptic drugs. Do not reinitiate in patients who have discontinued therapy due to aseptic meningitis. Monitor for signs of suicidal ideation & behaviors; clinical worsening in bipolar disorder. Concomitant use w/ hormonal contraceptives. Potential folate metabolism interference during long-term therapy. Patients w/ end-stage renal failure; those taking other lamotrigine-containing prep. Avoid abrupt w/drawal (reduce dosage gradually over a period of 2 wk). Hepatic or renal impairment. May interfere w/ rapid urine drug screens resulting in false +ve readings particularly for phencyclidine. May affect ability to drive or operate machinery. Pregnancy & lactation. Epilepsy: Childn <2 yr. Bipolar disorder: Childn & adolescents <18 yr.
Adverse Reactions
Skin rash; headache; somnolence, ataxia, dizziness; diplopia, blurred vision; nausea, vomiting. Aggression, irritability; nystagmus, tremor, insomnia; diarrhea; tiredness; agitation; arthralgia; pain, back pain.
Drug Interactions
Inhibited glucuronidation w/ valproate. Induced glucuronidation w/ carbamazepine, phenytoin, phenobarb, primidone, rifampicin, lopinavir/ritonavir, atazanavir/ritonavir, ethinyl estradiol/levonorgestrel. Increased clearance w/ hormonal contraceptives. May increase topiramate conc. Reduced plasma AUC & Cmax w/ atazanavir/ritonavir. Reports of CNS effects w/ carbamazepine.
MIMS Class
Anticonvulsants
ATC Classification
N03AX09 - lamotrigine ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Lamictal dispersible/chewable tab 25 mg
Packing/Price
30's
Form
Lamictal tab 100 mg
Packing/Price
30's
Form
Lamictal tab 50 mg
Packing/Price
30's
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