Lamictal

Lamictal

lamotrigine

Manufacturer:

GlaxoSmithKline Indonesia
Concise Prescribing Info
Contents
Lamotrigine
Indications/Uses
Adjunctive or monotherapy in treatment of epilepsy for partial & generalized seizures, including tonic-clonic seizures & seizures associated w/ Lennox-Gastaut syndrome in adults & adolescents >12 yr. Adjunctive treatment of epilepsy, for partial & generalized seizures including tonic-clonic seizures & seizures associated w/ Lennox-Gastaut syndrome in childn 2-12 yr. Prevention of mood episodes in patients w/ bipolar disorder, predominantly by preventing depressive episodes in adults ≥18 yr.
Dosage/Direction for Use
Epilepsy Adult & adolescent >12 yr Monotherapy Initially 25 mg once daily for 2 wk, followed by 50 mg once daily for 2 wk. Increase dose by max of 50-100 mg every 1-2 wk. Maintenance dose: 100-200 mg once daily or 2 divided doses up to 500 mg daily. Add-on therapy Patient taking valproate w/ or w/o any other antiepileptic drugs (AEDs) Initially 25 mg every alternate day for 2 wk, followed by 25 mg once daily for 2 wk. Increase dose by max of 25-50 mg every 1-2 wk. Maintenance dose: 100-200 mg once daily or in 2 divided doses. Patient taking concomitant 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 daily in 2 divided doses for 2 wk. Increase dose by max of 100 mg every 1-2 wk. Maintenance dose: 200-400 mg daily in 2 divided doses up to 700 mg daily. Patient taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation Initially 25 mg once daily for 2 wk, followed by 50 mg once daily for 2 wk. Increase dose by max of 50-100 mg every 1-2 wk. Maintenance dose: 100-200 mg once daily or in 2 divided doses. Childn 2-12 yr Add-on therapy Patient taking valproate w/ or w/o any other (AEDs) Initially 0.15 mg/kg/day once daily for 2 wk, followed by 0.3 mg/kg/day once daily for 2 wk. Increase dose by max of 0.3 mg/kg every 1-2 wk. Maintenance dose: 1-5 mg/kg/day once daily or in 2 divided doses. Max: 200 mg daily. 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. Increase dose by max of 1.2 mg/kg every 1-2 wk. Maintenance dose: 5-15 mg/kg/day in 2 divided doses. Max: 400 mg daily. Patient taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation Initially 0.3 mg/kg/day once daily or in 2 divided doses for 2 wk, followed by 0.6 mg/kg/day once daily or in 2 divided doses for 2 wk. Increase dose by max of 0.6 mg/kg every 1-2 wk. Maintenance dose: 1-10 mg/kg/day once daily or in 2 divided doses. Max: 200 mg daily. 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 in wk 5. Usual target dose: 100 mg/day 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 in wk 5. May be increased further to 300 mg/day in wk 6. Usual target dose: 400 mg/day in 2 divided doses for wk 7. Monotherapy or adjunct therapy in patient taking other medications that do not significantly induce or inhibit lamotrigine glucuronidation Initially 25 mg once a day for 2 wk, followed by 50 mg once daily or 2 divided doses for 2 wk. Increase dose to 100 mg/day in wk 5. Usual target dose: 200 mg/day once daily or in 2 divided doses. Following w/drawal of adjunct therapy w/ lamotrigine glucuronidation inhibitors eg, valproate Increase dose to double the original target stabilization dose & maintain. Following w/drawal of adjunct therapy w/ lamotrigine glucuronidation inducers depending on original maintenance dose (should be used w/ phenytoin, carbamazepine, phenobarb, primidone or other drugs known to induce lamotrigine glucuronidation) Gradually reduce dose over 3 wk. Following w/drawal of adjunct therapy w/ other medications that do not significantly inhibit or induce lamotrigine glucuronidation Maintain target dose. General dosing recommendations: Women taking hormonal contraceptives: Starting hormonal contraceptives in patient already taking maintenance doses & not taking lamotrigine glucuronidation inducers Maintenance dose: May be increased by as much as 2-fold. Stopping hormonal contraceptives in patient already taking maintenance doses & not taking lamotrigine glucuronidation inducers Maintenance dose: May be decreased by as much as 50%. Hepatic impairment: Moderate (Child-Pugh grade B) Reduce dose by approx 50%; Severe (Child-Pugh grade C) Reduce dose by 75%.
Administration
May be taken with or without food: Tab: Swallow whole, do not chew/crush. Dispersible tab: May be chewed, swallowed whole w/ little water, or dispersed in small volume of water (at least enough to cover whole tab). Do not administer partial quantities of the dispersed tab.
Contraindications
Special Precautions
Skin rash & fever during 1st 8 wk of therapy in childn. History of allergy/rash to other antiepileptic drugs. Not to be restarted in patients who have discontinued due to rash or aseptic meningitis associated w/ prior treatment. Haemophagocytic lymphohistiocytosis. Monitor for signs of suicidal ideation & behaviours; clinical worsening (including development of new symptoms) & suicidality especially at the start of therapy or when the dose changes; history of suicidal behaviour or thoughts, young adults, patients exhibiting significant degree of suicidal ideation prior to start of therapy. Concomitant use w/ hormonal contraceptives, or other prep containing lamotrigine. Report changes in menstrual pattern eg, breakthrough bleeding. Not recommended in co-administration w/ organic cationic transporter 2 (OCT 2) substrates w/ a narrow therapeutic index eg, dofetilide. Possibility of interference w/ folate metabolism during long-term therapy. Patients w/ renal failure; Brugada syndrome. May further increase risk of proarrhythmia w/ other Na channel blocker. May affect ability to drive or operate machinery. Pregnancy & lactation. Epilepsy: Abrupt w/drawal may provoke rebound seizures. Avoid abrupt w/drawal (reduce dosage gradually over a period of 2 wk) unless safety concerns eg, rash. Severe convulsive seizures including status epilepticus may lead to rhabdomyolysis, multiorgan dysfunction & disseminated intravascular coagulation. Childn <2 yr. Bipolar disorder: Increased risk of suicidal thinking & behaviour in childn & adolescents <18 yr w/ major depressive disorder & other psychiatric disorders. Not to be used in childn & adolescents <18 yr.
Adverse Reactions
Skin rash; headache; somnolence, ataxia, dizziness; diplopia, blurred vision; nausea, vomiting. Aggression, irritability; insomnia, tremor; diarrhoea; tiredness; agitation; arthralgia; pain, back pain; nystagmus.
Drug Interactions
Apparent clearance may be affected by drugs that induce or inhibit glucuronidation. Metabolism may be enhanced by strong or moderate inducers of CYP3A4 enzyme. Reduced metabolism & increased t½ nearly 2-fold w/ valproate. Enhanced metabolism w/ atazanavir/ritonavir, carbamazepine, ethinylestradiol/levonorgestrel combination, lopinavir/ritonavir, phenobarb, phenytoin, primidone, rifampicin. CNS events including dizziness, ataxia, diplopia, blurred vision & nausea w/ carbamazepine & oxcarbazepine. May increase topiramate conc. Increased clearance by <10% w/ perampenal highest dose (12 mg/day). Reduced AUC & Cmax w/ olanzapine, aripiprazole, hormonal contraceptives, atazanavir/ritonavir. Minimal effect on lamotrigine's primary metabolite by co-incubation w/ amitriptyline, bupropion, clonazepam, fluoxetine, haloperidol, or lorazepam. Reduced AUC & Cmax of levonorgestrel. Reduced plasma AUC & Cmin w/ paracetamol. Inhibits OCT 2. Interferes assay in some rapid urine drug screens ie, false +ve readings for phencyclidine.
MIMS Class
Anticonvulsants
ATC Classification
N03AX09 - lamotrigine ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Lamictal Disp tab 25 mg
Packing/Price
30's
Form
Lamictal Disp tab 5 mg
Packing/Price
30's
Form
Lamictal Tab 100 mg
Packing/Price
30's
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