Lamotrigine | Lamictal
LAMICTAL is indicated for:
Epilepsy—adjunctive therapy in patients aged 2 years and older:
- partial-onset seizures.
- primary generalized tonic-clonic seizures.
- generalized seizures of Lennox-Gastaut syndrome. (1.1)
Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED. (1.1)
Bipolar disorder in patients aged 18 years and older: 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. (1.2)
Dosage Forms and Strengths:
- Tablets: 25 mg, 100 mg, 150 mg, and 200 mg; scored. (3.1, 16)
- Chewable dispersible tablets: 2 mg, 5 mg, and 25 mg. (3.2, 16)
- Orally disintegrating tablets: 25 mg, 50 mg, 100 mg, and 200 mg. (3.3, 16)
Lamotrigine | Lamictal Prescribing Information Highlights
The following points are shortened, highlighted information from prescribing information for this drug. For the full prescribing information PDF, click the button below to be directed to the FDA PDF label for this drug.
—–INDICATIONS AND USAGE—–
- See description above.
—–DOSAGE AND ADMINISTRATION—–
- See description above.
- Hypersensitivity to the drug or its ingredients. (Boxed Warning, 4)
- Life-threatening serious rash and/or rash-related death: Discontinue at the first sign of rash, unless the rash is clearly not drug related. (Boxed Warning, 5.1)
- Fatal or life-threatening hypersensitivity reaction: Multiorgan hypersensitivity reactions, also known as drug reaction with eosinophilia and systemic symptoms (DRESS), may be fatal or life threatening. Early signs may include rash, fever, and lymphadenopathy. These reactions may be associated with other organ involvement, such as hepatitis, hepatic failure, blood dyscrasias, or acute multiorgan failure. LAMICTAL should be discontinued if alternate etiology for this reaction is not found. (5.2)
- Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia): May occur, either with or without an associated hypersensitivity syndrome. Monitor for signs of anemia, unexpected infection, or bleeding. (5.3)
- Suicidal behavior and ideation: Monitor for suicidal thoughts or behaviors. (5.4)
- 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. (5.5)
- Aseptic meningitis: Monitor for signs of meningitis. (5.6)
- Medication errors due to product name confusion: Strongly advise patients to visually inspect tablets to verify the received drug is correct. (5.7, 16, 17)
- Epilepsy: Most common adverse reactions (incidence ≥10%) in adults were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, pharyngitis, and rash. Additional adverse reactions (incidence ≥10%) reported in children included vomiting, infection, fever, accidental injury, diarrhea, abdominal pain, and tremor. (6.1)
- Bipolar disorder: Most common adverse reactions (incidence >5%) were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia. (6.1)
- Valproate increases lamotrigine concentrations more than 2-fold. (7, 12.3)
- Carbamazepine, phenytoin, phenobarbital, primidone, and rifampin decrease lamotrigine concentrations by approximately 40%. (7, 12.3)
- Estrogen-containing oral contraceptives decrease lamotrigine concentrations by approximately 50%. (7, 12.3)
- Protease inhibitors lopinavir/ritonavir and atazanavir/lopinavir decrease lamotrigine exposure by approximately 50% and 32%, respectively. (7, 12.3)
- Coadministration with organic cationic transporter 2 substrates with narrow therapeutic index is not recommended (7, 12.3)