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Lamitor 50/Lamitor-100

Lamitor 50/Lamitor-100

lamotrigine

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Lamotrigine
Indications/Uses
Monotherapy & adjunctive treatment of partial seizures & primary & secondary generalized tonic-clonic seizures, seizures associated w/ Lennox-Gastaut syndrome. Prophylaxis of bipolar disorder in adults.
Dosage/Direction for Use
Epilepsy monotherapy Adult & childn >12 yr Initially 25 mg once daily for 2 wk followed by 50 mg once daily for 2 wk. Thereafter, increase by 50 mg/day every 1-2 wk to usual maintenance dose of 225-375 mg daily given in 2 divided doses. Childn 2-12 yr Initially 300 mcg/kg daily in 1 or 2 divided doses for 2 wk followed by 600 mcg/kg in 2 divided doses for 2 wk. Thereafter, increase by 600 mcg/kg daily every 1-2 wk to usual maintenance dose of 4.5-7.5 mg/kg daily (max: 300 mg daily in 2 divided doses). Epilepsy add-on therapy (w/o valproate) Adult 50 mg once daily for 2 wk followed by 50 mg bid for 2 wk. Thereafter, increase by 100 mg/day every 1-2 wk to usual maintenance dose of 300-500 mg daily in 2 divided doses. Childn 2-12 yr Initially 600 mcg/kg daily in 2 divided dosed for 2 wk followed by 1.2 mg/kg in 2 divided doses for 2 wk. Thereafter, increase by a max of 1.2 mg/kg every 1-2 wk to usual maintenance dose of 5-15 mg/kg in 2 divided doses (max: 400 mg/day). Epilepsy add-on therapy (w/ valproate) Adult Initially 25 mg every other day for 2 wk followed by 25 mg once daily for 2 wk. Thereafter, increase by 25-50 mg/day every 1-2 wk to usual maintenance dose of 100-200 mg daily w/ valproate alone & 100-400 mg daily w/ valproate & other drugs that induce glucuronidation given as a single dose or in 2 divided doses. Childn Initially 150 mcg/kg once daily for 2 wk followed by 300 mcg/kg once daily for 2 wk. Thereafter, increase by 300 mcg/kg every 1-2 wk to usual maintenance dose of 1-5 mg/kg (max: 200 mg/day) given as once daily or in 2 divided doses & 1-3 mg/kg/day for those taking valproate alone as an add-on. Epilepsy usual adjunctive maintenance Patient receiving multidrug regimens employing carbamazepine, phenytoin, phenobarb or primidone w/o valproate As high as 700 mg/day. Patient receiving valproate alone As high as 200 mg/day. Bipolar disorder monotherapy Initially 25 mg once daily, gradually increased to 200 mg daily over 6 wk. Patient taking valproate 25 mg every other day & target dosage of 100 mg/day from wk 6. Patient w/ carbamazepine or other enzyme inducing drugs Initially 50 mg once daily, gradually increased up to 400 mg/day from wk 7. Dosages >50 mg/day can be given once daily or as 2 divided doses.
Administration
May be taken with or without food.
Special Precautions
Discontinue at the 1st sign of rash unless clearly not drug-related. Multiorgan hypersensitivity reactions may be associated w/ other organ involvement eg, hepatitis, hepatic failure, blood dyscrasias, or acute multiorgan failure; discontinue if no other cause is identified. Increased risk of suicidal thoughts or behavior; developing aseptic meningitis. Monitor for signs of anemia, unexpected infection, or bleeding; emergence or worsening of depression, suicidal thoughts or behavior, &/or any unusual changes in mood or behavior; signs & symptoms of meningitis. Possibility of long-term ophth effects. Do not abruptly discontinue treatment. Concomitant use w/ OCs; multidrug regimen including valproate. Pregnancy & lactation.
Adverse Reactions
Skin rashes eg, SJS & TEN especially in childn. Hypersensitivity syndrome. Angioedema & photosensitivity, diplopia, blurred vision & conjunctivitis, dizziness, drowsiness, insomnia, headache, ataxia, nystagmus, tremor, tiredness, nausea & vomiting, irritability & aggression, hallucinations, agitation & confusion, somnolence, rhinitis, pharyngitis, infection, diarrhea, abdominal or back pain, xerostomia.
Drug Interactions
Enhanced metabolism w/ enzyme inducers carbamazepine, phenytoin, phenobarb & primidone. Inhibited metabolism w/ valproate. Increased clearance w/ rifampicin. Decreased exposure w/ PIs (eg, lopinavir/ritonavir & atazanavir/lopinavir). Co-administration w/ OCT2 substrates w/ narrow therapeutic index (eg, dofetilide) is not recommended. Decreased serum conc w/ some estrogen-containing OCs.
MIMS Class
Anticonvulsants
ATC Classification
N03AX09 - lamotrigine ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Lamitor 50 tab 50 mg
Packing/Price
30's (P990/pack)
Form
Lamitor-100 tab 100 mg
Packing/Price
30's (P1,566/pack)
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