Apo-Lamotrigine

Apo-Lamotrigine

lamotrigine

Manufacturer:

Apotex

Distributor:

Pharmaforte
Concise Prescribing Info
Contents
Lamotrigine
Indications/Uses
Adjunctive or monotherapy in the treatment of epilepsy, partial & generalised seizures, including tonic-clonic seizures & seizures associated w/ Lennox-Gastaut syndrome in adult (>12 yr). Adjunctive treatment of epilepsy, partial & generalised seizures, including tonic-clonic seizures & seizures associated w/ Lennox-Gastaut syndrome in childn (2-12 yr). Prevention of depressive episodes in adults ≥18 yr 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. Increased by a max of 50-100 mg every 1-2 wk. Maintenance: 100-200 mg once daily or as 2 divided doses. Add-on therapy Patient taking valproate w/ or w/o other antiepileptic drugs (AED) Initially 25 mg every alternate day for 2 wk followed by 25 mg once daily for 2 wk. Increased by a max of 25-50 mg every 1-2 wk. Maintenance: 100-200 mg once daily or in 2 divided doses. Patient taking concomitant AED or other medications that induce lamotrigine glucuronidation w/ or w/o other AED (except valproate) Initially 50 mg once daily for 2 wk followed by 100 once daily in 2 divided doses for 2 wk. Increased by a max of 100 mg every 1-2 wk. Maintenance: 200-400 mg once daily in 2 divided doses. Patient taking oxcarbazepine w/o any other inducers or inhibitors of lamotrigine glucuronidation Initially 25 mg once daily for 2 wk followed by 50 mg once daily for 2 wk. Increased by a max of 50-100 mg every 1-2 wk. Maintenance: 100-200 mg once daily or as 2 divided doses. Childn 2-12 yr Add-on therapy Patient taking valproate w/ or w/o other AED Initially 0.15 mg/kg/day once daily for 2 wk followed by 0.3 mg/kg/day once daily for 2 wk. Increased by a max of 0.3 mg/kg every 1-2 wk. Maintenance: 1-5 mg/kg/day given once daily or in 2 divided doses. Max: 200 mg once daily. Patient taking concomitant AED or other medications that induce lamotrigine glucuronidation w/ or w/o AED (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. Increased by a max of 1.2 mg/kg every 1-2 wk. Maintenance: 5-15 mg/kg/day in 2 divided doses. Max: 400 mg once daily. Bipolar disorder Adult (≥18 yr) Adjunctive therapy w/ inducers of lamotrigine glucuronidation in patient not taking inhibitors eg, valproate Initially 50 mg once daily for 2 wk followed by 100 mg/day in 2 divided doses for 2 wk, increased to 200 mg/day in 2 divided doses in wk 5. May be increased to 300 mg/day in wk 6. Target dose: 400 mg/day in 2 divided doses for wk 7. Adjunctive therapy w/ inhibitors of lamotrigine glucuronidation eg, valproate Initially 25 mg every alternate day for 2 wk followed by 25 mg once daily for 2 wk, increased to 50 mg once daily or in 2 divided doses in wk 5. Target dose: 100 mg/day given once daily or in 2 divided doses. Max: 200 mg/day. Monotherapy or use w/ drugs that do not 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, increased to 100 mg/day in wk 5. Target dose: 200 mg/day given once daily or as 2 divided doses. Maintenance stabilisation dose following w/drawal of inhibitors of lamotrigine glucuronidation eg, valproate Double the stabilisation dose not exceeding 100 mg/wk for wk 1 then maintain 200 mg/day for wk 2 onwards given in 2 divided doses. Following w/drawal of lamotrigine glucuronidation inducers Reduce wkly by 50-100 mg decrements. W/ other psychotropic or AEDs Maintain target dose achieved in dose escalation (200 mg/day) in 2 divided doses.
Administration
May be taken with or without food: May be chewed, swallowed whole or dispersed in water/diluted fruit juice. To disperse, add the tab to a small amount of liqd in a glass (1 tsp or enough to cover). When the tab is completely dispersed (approx 1 min), swirl the soln & consume the entire quantity immediately.
Special Precautions
Closely monitor & consider w/drawal if hypersensitivity syndrome (rash, fever, lymphadenopathy, facial oedema & abnormalities of the blood & liver) develops. Women who are starting or stopping hormonal contraceptives during therapy. Report changes in menstrual pattern ie, breakthrough bleeding. Cases of acute multi-organ failure & long-term ophth effects. Increased risk of developing aseptic meningitis. Avoid abrupt w/drawal in epilepsy (taper dosage over a period of 2 wk) unless serious skin reaction occurs. Renal failure. History of suicidal behavior or thoughts; patients exhibiting significant degree of suicidal ideation. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <2 yr. Initial monotherapy is not recommended in newly diagnosed paed patients. Elderly >65 yr.
Adverse Reactions
Skin rash, headache, dizziness, diplopia, blurred vision. Irritability; drowsiness, insomnia, tremor; nystagmus, ataxia; GI disturbance (vomiting & diarrhoea); tiredness; agitation, somnolence; arthralgia; pain, back pain.
Drug Interactions
Reduced metabolism & increased mean-t½ w/ valproate. Induced & enhanced metabolism w/ anti-epileptic agents (eg, phenytoin, carbamazepine, phenobarb & primidone). Increased oral clearance w/ ethinyloestradiol/levonorgestrel combination. Increased clearance & decreased t½ w/ rifampicin.
MIMS Class
Anticonvulsants
ATC Classification
N03AX09 - lamotrigine ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Apo-Lamotrigine tab 100 mg
Packing/Price
100's
Form
Apo-Lamotrigine tab 25 mg
Packing/Price
100's
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