Lamotrigine

DEA Class;  Rx

Common Brand Names; Lamictal, Lamictal XR, Lamictal ODT

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