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Lamido

Lamido

lamotrigine

Manufacturer:

Yarindo Farmatama
Concise Prescribing Info
Contents
Lamotrigine
Indications/Uses
Monotherapy in adults >12 yr or add-on therapy in adults & childn 2-12 yr w/ tonic-clonic seizures & seizures associated w/ Lennox-Gastaut syndrome. Mood stabilizer in prevention of depressive episode in patients w/ bipolar disorder.
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. Then increase by max of 50-100 mg every 1-2 wk until optimal response is obtained. Maintenance dose: 100-200 mg once daily or in 2 divided doses up to 500 mg daily. Add-on therapy: Initially 25 mg every alternate day for 2 wk, followed by 25 mg once daily for 2 wk, then increase dose by max 25-50 mg every 1-2 wk. Maintenance dose: 100-200 mg once daily or in 2 divided doses. Patient taking concomitant antiepileptic drugs (AEDs) or other medications that induce lamotrigine glucuronidation w/ or w/o AEDs (except valproate) Initially 50 mg once daily for 2 wk, followed by 100 mg daily in 2 divided doses for 2 wk. Then, 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. Then, increase dose by max 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 once daily for 2 wk, followed by 0.3 mg/kg once daily for 2 wk. Then, increase dose by max of 0.3 mg/kg every 1-2 wk. Maintenance dose: 1-5 mg/kg once daily or in 2 divided doses. Max: 200 mg daily. Patient taking concomitant AEDs or other medications that induce lamotrigine glucuronidase w/ or w/o other AEDs (except valproate) Initially 0.6 mg/kg daily in 2 divided doses for 2 wk, followed by 1.2 mg/kg daily in 2 divided doses for 2 wk. Then, increase dose by max of 1.2 mg/kg every 1-2 wk. Maintenance dose: 5-15 mg/kg daily 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 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. Then, increase dose by max 0.6 mg/kg every 1-2 wk. Maintenance dose: 1-10 mg/kg 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. Then, increase dose to 50 mg once daily or in 2 divided doses in wk 5. Usual target dose: 100 mg once daily or in 2 divided doses. Max: 200 mg daily. Adjunct therapy w/ lamotrigine glucuronidase inducers in patient not taking inhibitors eg, valproate (should be used w/ phenytoin, carbamazepine, phenobarb, primidone, or other drugs known to induce lamotrigine glucuronidation) Initially 50 mg once daily for 2 wk, followed by 100 mg in 2 divided doses for 2 wk. Then, increase dose to 200 mg daily in 2 divided doses in wk 5. May be increased further to 300 mg daily in wk 6. Usual target dose: 400 mg daily 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 daily for 2 wk, followed by 50 mg once daily or in 2 divided doses for 2 wk. Increase dose to 100 mg once daily or in 2 divided doses for 2 wk. Then, increase dose to 100 mg daily in wk 5. Usual target dose: 200 mg once daily or in 2 divided doses.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Special Precautions
Discontinue treatment if haemophagocytic lymphohistiocytosis (HLH) occurs. W/draw treatment at 1st sign of rash, fever or lymphadenopathy, facial oedema, blood abnormalities, liver & kidney & aseptic meningitis. Do not restart in patients who have discontinued due to rash or aseptic meningitis associated w/ prior treatment. Potentially life-threatening rashes eg, SJS & TEN. Possible drug reaction during 1st 8 wk of therapy. DRESS. Monitor for signs of suicidal ideation & behaviours & clinical worsening of bipolar disorder at treatment initiation or dose changes. Patients w/ history of allergy or rash to other antiepileptic drugs; suicidal behaviour or thoughts, young adults & those exhibiting significant degree of suicidal ideation prior to commencement of treatment; renal failure; Brugada syndrome. Evaluate patients for HLH if signs & symptoms eg, fever, rash, neurological symptoms, hepatosplenomegaly, lymphadenopathy, cytopenias, high serum ferritin, hypertriglyceridaemia & abnormal liver function & coagulation develop w/in 4 wk of treatment initiation. Promptly report changes in menstrual pattern ie, breakthrough bleeding. Taper dose gradually to avoid rebound seizures. Not recommended co-administration w/ organic cationic transporter 2 substrates w/ narrow therapeutic index eg, dofetilide. Do not administer lamotrigine tab w/ other lamotrigine-containing prep. Concomitant use w/ hormonal contraceptives. Possible interference w/ folate metabolism during long-term therapy. May affect ability to drive & use machines. Pregnancy & lactation. Increased risk of suicidal thinking & behaviour in childn & adolescents (<18 yr) w/ major depressive disorder & other psychiatric disorders.
Adverse Reactions
Skin rash; headache. Aggression, irritability; somnolence, insomnia, dizziness, tremor; nausea, vomiting, diarrhea; tiredness; agitation; arthralgia; pain, back pain. SJS, TEN & DRESS.
Drug Interactions
Co-administration w/ valproate, carbamazepine, phenytoin, primidone, phenobarb, rifampicin, lopinavir/ritonavir, atazanavir/ritonavir, ethinylestradiol/levonorgestrel, lithium, bupropion, olanzapine, oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamide, aripiprazole, lacosamide, perampanel. May cause false +ve readings, particularly for phencyclidine (PCP).
MIMS Class
Anticonvulsants
ATC Classification
N03AX09 - lamotrigine ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Lamido tab 100 mg
Packing/Price
3 × 10's
Form
Lamido tab 50 mg
Packing/Price
3 × 10's
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