Uses
Side effects
Interactions
Precautions
LAMICTAL is an antiepileptic drug (AED) indicated for: Epilepsy—adjunctive therapy in patients ≥2 years of age:
- partial seizures.
- primary generalized tonic-clonic seizures.
- generalized seizures of Lennox-Gastaut syndrome. Epilepsy—monotherapy in patients ≥16 years of age: conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single AED.
- Bipolar Disorder in patients ≥18 years of age: maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.
- Most common adverse reactions (incidence ≥10%) in adult epilepsy clinical studies were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, and rash. Additional adverse reactions (incidence ≥10%) reported in children in epilepsy clinical studies included vomiting, infection, fever, accidental injury, pharyngitis, abdominal pain, and tremor.
• Most common adverse reactions (incidence >5%) in adult bipolar clinical studies were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia.
- Valproate increases lamotrigine concentrations more than 2-fold.
- Carbamazepine, phenytoin, phenobarbital, and primidone decrease lamotrigine concentrations by approximately 40%.
• Oral estrogen-containing contraceptives and rifampin also decrease lamotrigine concentrations by approximately 50%.
- Life-threatening serious rash and/or rash-related death may result. (Boxed Warning,
- Hypersensitivity reaction may be fatal or life-threatening. Early signs of hypersensitivity (e.g., fever, lymphadenopathy) may present without rash; if signs present, patient should be evaluated immediately. LAMICTAL should be discontinued if alternate etiology for hypersensitivity signs is not found.
- Acute multiorgan failure has resulted (some cases fatal).
- Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia), may result either with or without an associated hypersensitivity syndrome.
- Suicidal behavior and ideation.
- Clinical worsening, emergence of new symptoms, and suicidal ideation/behaviors may be associated with treatment of bipolar disorder. Patients should be closely monitored, particularly early in treatment or during dosage changes.
- Medication errors involving LAMICTAL have occurred. In particular the names LAMICTAL or lamotrigine can be confused with names of other commonly used medications. Medication errors may also occur between the different formulations of LAMICTAL
