Epsylam DT

Epsylam DT

lamotrigine

Manufacturer:

Aurobindo Pharma

Distributor:

Unimed
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. Prevention of mood episodes in patients w/ bipolar disorder predominantly by preventing depressive episodes.
Dosage/Direction for Use
Adult >16 yr Epilepsy monotherapy Initially 25 mg once daily for 2 wk, followed by 50 mg once daily for 2 wk. May be increased to max: 50-100 mg every 1-2 wk. Maintenance: 100-200 mg once daily or as 2 divided doses. Adult >12 yr Add-on therapy w/ valproate Initially 25 mg every alternate day for 2 wk, followed by 25 mg once daily for 2 wk. May be increased to max: 25-50 mg every 1-2 wk. Maintenance: 100-200 mg once daily or in 2 divided doses. Add-on therapy w/ antiepileptics or other lamotrigine glucuronidation inducers Initially 50 mg once daily for 2 wk, followed by 100 mg daily in 2 divided doses for 2 wk. May be increased to max: 100 mg every 1-2 wk. Maintenance: 200-400 mg daily in 2 divided doses. Add-on therapy w/ oxcarbazepine w/o lamotrigine glucuronidation inhibitors or inducers Initially 25 mg once daily for 2 wk, followed by 50 mg once daily for 2 wk. May be increased to max: 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 w/ valproate Initially 0.15 mg/kg once daily for 2 wk, followed by 0.3 mg/kg once daily for 2 wk. May be increased to max: 0.3 mg/kg every 1-2 wk. Maintenance: 1-5 mg/kg once daily or in 2 divided doses. Max: 200 mg daily. Add-on therapy w/ antiepileptics or other lamotrigine glucuronidation inducers 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. May be increased to max: 1.2 mg/kg every 1-2 wk. Maintenance: 5-15 mg/kg daily in 2 divided doses. Max: 400 mg daily. Add-on therapy w/ oxcarbazepine w/o any lamotrigine glucuronidation inhibitors or inducers 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. May be increased to max: 0.6 mg/kg every 1-2 wk. Maintenance: 1-10 mg/kg once daily or in 2 divided doses. Max: 200 mg daily. Adult ≥18 yr Bipolar disorder adjunct therapy w/ valproate Initially 25 mg every alternate day for 2 wk, followed by 25 mg once daily for 2 wk. May be increased to 50 mg once daily or in 2 divided doses for 1 wk. Usual target dose: 100 mg once daily or in 2 divided doses, may be increased to max: 200 mg daily. Adjunct therapy w/ phenytoin, carbamazepine, phenobarb, primidone & other lamotrigine glucuronidation inducers Initially 50 mg once daily for 2 wk, followed by 100 mg daily in 2 divided doses for 2 wk. May be increased to 200 mg daily as 2 divided doses for 1 wk, then further increased to 300 mg daily for 1 wk. Usual target dose: 400 mg daily in 2 divided doses for 1 wk. Monotherapy or adjunct therapy w/ drugs 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. May be increased to 100 mg daily for 1 wk. Usual target dose: 200 mg once daily or as 2 divided doses.
Administration
May be taken with or without food: Tab may be swallowed whole, chewed, or dispersed in a small amount of water.
Contraindications
Special Precautions
History of allergy or rash to other antiepileptic drugs. Not to be restarted in patients who have discontinued due to rash. Monitor for clinical worsening & suicidal ideation/behaviour, thoughts. Interference w/ folate metabolism during long-term therapy. Avoid abrupt w/drawal. Not to be administered concurrently w/ other lamotrigine-containing prep. Not recommended in concomitant use w/ OCT2 substrates eg, dofetilide. Concomitant use w/ hormonal contraceptives. Moderate & severe hepatic impairment. Renal impairment & failure. Pregnancy & lactation. Not to be used in childn & adolescents <18 yr w/ bipolar disorder. Childn & adolescents <18 yr w/ major depressive & other psychiatric disorders; childn <2 yr w/ epilepsy.
Adverse Reactions
Skin rash; somnolence, ataxia, headache, dizziness; diplopia, blurred vision; nausea, vomiting. Aggression, irritability; nystagmus, tremor, insomnia, agitation; diarrhoea; tiredness; arthralgia; pain, back pain.
Drug Interactions
Inhibited glucuronidation by valproate. Induced glucuronidation by carbamazepine, phenytoin, primidone, phenobarb, rifampicin, lopinavir/ritonavir/atazanavir, ethinylestradiol/levonorgestrel combination. Increased clearance by rifampicin. Halved plasma conc w/ lopinavir/ritonavir. Reduced plasma AUC & Cmax w/ atazanavir/ritonavir.
MIMS Class
ATC Classification
N03AX09 - lamotrigine ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Epsylam DT dispersible tab 50 mg
Packing/Price
10 × 10's;3 × 10's
Form
Epsylam DT dispersible tab 100 mg
Packing/Price
10 × 10's;3 × 10's
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