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Lamotrigine

    Brands

    DEA Class;  Rx

    Common Brand Names; Lamictal, Lamictal XR, Lamictal ODT

    • Anticonvulsants, Other

    Oral antiepileptic drug (AED)
    Used for adjunctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome; conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with certain other AEDs; and maintenance treatment of bipolar I disorder
    Associated with life-threatening serious rashes and/or rash-related death, more frequently in pediatric patients

    Indicated for the treatment of partial seizures with or without secondary generalization.

    For adjunctive therapy to other anticonvulsants in the treatment of primary generalized tonic-clonic seizures.

    For adjunctive therapy to other anticonvulsants in the treatment of generalized seizures of Lennox-Gastaut syndrome.

    For the long-term maintenance treatment of bipolar disorder (bipolar I disorder) to delay the occurrence of mood episodes (i.e., depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.

    For long-term prophylaxis of short-lasting unilateral neuralgiform headache with conjunctival injection and tearing (SUNCT).
    For the treatment of trigeminal neuralgia.

    Hypersensitivity to any component of formulation

    • Dizziness (38%)
    • Diplopia (26-30%)
    • Headache (29%)
    • Ataxia (22%)
    • Blurred vision (16-20%)
    • Rhinitis (11-15%)
    • Somnolence (14%)
    • Insomnia (6-10%)
    • Fatigue (8%)
    • Chest pain (5%)
    • Peripheral edema (2-5%)
    • Suicidal ideation (2-5%)
    • Dermatitis (2-5%)
    • Dry skin (2-5%)
    • Increased libido (2-5%)
    • Rectal hemorrhage (2-5%)
    • Weakness (2-5%)
    • Agitation (1-5%)
    • Dysarthria (1-5%)
    • Edema (1-5%)
    • Fever (1-5%)
    • Migraine (1-5%)
    • Abnormal thoughts (1-5%)
    • Urinary frequency (1-5%)
    • Tremor (4%)
    • Palpitations
    • Anxiety
    • Chills
    • Depression
    • Decreased memory
    • Emotional lability
    • Incoordination
    • Malaise
    • Seizure exacerbation
    • Vertigo
    • Pruritus
    • Rash
    • Amenorrhea
    • Hot flashes
    • Abdominal pain
    • Constipation
    • Diarrhea
    • Dyspepsia
    • Nausea
    • Vomiting
    • Arthralgia
    • Neck pain
    • Cough
    • Flu syndrome
    • Infection
    • Vaginitis
    • Nystagmus
    • Agranulocytosis, hemolytic anemia, lymphadenopathy not associated with hypersensitivity disorder
    • Esophagitis
    • Aseptic meningitis
    • Pancreatitis
    • Lupus-like reaction
    • Vasculitis
    • Apnea
    • Rhabdomyolysis observed in patients experiencing hypersensitivity reactions
    • Aggression
    • Exacerbation of Parkinsonian symptoms in patients with pre-existing Parkinson’s disease, tics
    • Progressive immunosuppression
    • Cardiac rhythm and conduction abnormalities

    See FDA Warning on potential suicidal behavior

    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

    Use caution in renal impairment and hepatic impairment; dose adjustments may be necessary

    Risk of serious rash; discontinue at first sign of rash (see Black Box Warnings)

    Rare cases of toxic epidermal necrolysis have been reported in worldwide postmarketing experience

    May cause CNS depression; use caution operating heavy machinery

    Multiorgan hypersensitivity reactions, also known as drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported, with possible multiorgan failure (see Black Box Warning)

    Round pediatric dose downward to nearest 5 mg

    Do not withdraw abruptly

    Need to modify dosage if adding or discontinuing hepatic enzyme-inducing anticonvulsant drugs or valproic acid

    Increased risk of hematologic effects (eg, neutropenia, anemia, leukopenia, thrombocytopenia, aplastic anemia) in patients with previous history of adverse hematologic reactions to any drug

    Need to modify dosage if taking or stopping estrogen plus oral contraceptives

    Risk of isolated oral clefts if used in early pregnancy

    Aseptic meningitis cases reported; symptoms may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light

    May interfere with the assay used in some rapid urine drug screens, which can result in false-positive readings, particularly for phencyclidine (PCP); use a more specific analytical method to confirm a positive result

    A pregnancy exposure registry monitors pregnancy outcomes in women exposed to AEDs, including lamotrigine, during pregnancy

    Drug is present in milk from lactating women receiving therapy; neonates and young infants are at risk for high serum levels because maternal serum and milk levels can rise to high levels postpartum if lamotrigine dosage has been increased during pregnancy but is not reduced to pre-pregnancy dosage after delivery

    Adults

    In seizure disorders, individualize to the patient’s age, weight, indication, concurrent medication, and clinical response. In bipolar disorder, maximum monotherapy dosage is 200 mg/day PO; 100 mg/day PO if taking valproate; 400 mg/day PO if taking enzyme-inducing drugs.

    Elderly

    In seizure disorders, individualize to the patient’s age, weight, indication, concurrent medication, and clinical response. In bipolar disorder, maximum monotherapy dosage is 200 mg/day PO; 100 mg/day PO if taking valproate; 400 mg/day PO if taking enzyme-inducing drugs.

    Adolescents

    In seizure disorders, individualize to the patient’s age, weight, indication, concurrent medication, and clinical response. Safe and effective use in bipolar disorder has not been established.

    Children

    >= 2 years: In seizure disorders, individualize to the patient’s age, weight, indication, concurrent medication, and clinical response. Safe and effective use in bipolar disorder has not been established. Safe and effective use of extended-release formulation has not been established. Guidelines: Children receiving valproate: 200 mg/day PO as adjunct treatment. Children receiving enzyme-inducing AEDs (e.g., carbamazepine, phenobarbital, phenytoin, primidone) WITHOUT valproate: 400 mg/day PO as adjunct treatment. Children receiving AEDs OTHER than carbamazepine, phenobarbital, phenytoin, primidone, or valproate: 300 mg/day PO as adjunct treatment.
    < 2 years: Safety and efficacy have not been established.

    Lamotrigine

    tablet

    • 25mg
    • 100mg
    • 150mg
    • 200mg

    tablet, chewable

    • 2mg
    • 5mg
    • 25mg

    tablet, oral-disintegrating

    • 25mg
    • 50mg
    • 100mg
    • 200mg

    tablet, extended-release

    • 25mg
    • 50mg
    • 100mg
    • 200mg
    • 250mg
    • 300mg