Oxcarbazepine

DEA Class;  Rx

Common Brand Names; Trileptal, Oxtellar XR

Known hypersensitivity to oxcarbazepine or any of its components, or to eslicarbazepine acetate

• Dizziness (30-50%)
• Diplopia (30-50%)
• Headache (26-30%)
• Nausea/vomiting (26-30%)
• Nystagmus (26-30%)
• Somnolence (26-30%)
• Ataxia (10-30%)
• Abnormal gait (16-20%)
• Tremor (16-20%)
• Abdominal pain (11-15%)
• Fatigue (11-15%)
• Vertigo (11-15%)
• Vision abnormalities (11-15%)
• Dyspepsia (5-6%)
• Rash (4%)
• Insomnia (2-4%)
• Abnormal thinking (<4%)
• Hyponatremia (1-3%)
• Muscle weakness (1-2%)
• Hypotension (<2%)
• Speech disorder (1%)
• Asthenia
• Angioedema
• Anaphylaxis
• Multiorgan immune hypersensitivity reaction
• Hematic and lymphatic systems: Bone marrow depression, agranulocytosis, aplastic anemia, pancytopenia, neutropenia
• Digestive system: Pancreatitis and/or lipase and/or amylase increased
• Metabolism and nutrition disorders: Folic acid deficiency, hypothyroidism
• Skin and appendages: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
• Skeletal: Fractures, decreased bone mineral, osteoporosis
• Body as a whole: Multiorgan hypersensitivity disorders characterized by features such as rash, fever, lymphadenopathy, abnormal liver function tests, eosinophilia, and arthralgia
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity

Hypersensitivity reactions may occur; if signs or symptoms of hypersensitivity develop, discontinue treatment immediately

Antiepileptic drugs (AEDs) increase risk of suicidal thoughts or behavior in patients receiving therapy; monitor for emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior

Caution performing tasks that require mental alertness

Potentially fatal skin reactions may occur (eg, Stevens-Johnson syndrome)

Discontinue if dermatological reactions occur

Significant hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) may develop (monitor especially in patients at risk of hyponatremia)

Pancytopenia, agranulocytosis, and leukopenia reported rarely

Hypothyroidism reported; monitor thyroid function, especially in children; discontinuation of therapy associated with return of normal thyroxine levels

Patients carrying the HLA-B*1502 allele may be at increased risk for Stevens-Johnson syndrome and epidermal necrolysis

Half-life of primary active metabolite is prolonged 3- to 4-fold and AUC is doubled in patients with CrCl <30 mL/min; adjust dose in these patients

Exacerbation of or new onset of primary generalized seizures reported; risk of aggravation of primary generalized seizures is seen especially in children but may also occur in adults; discontinue therapy if it occurs

Do not discontinue anticonvulsants abruptly; withdraw gradually because of risk of increased seizure frequency and status epilepticus; if withdrawal is needed because of serious adverse event, rapid discontinuation can be considered

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as TRILEPTAL, during pregnancy. 

Oxcarbazepine and its active metabolite (MHD) are excreted in human milk

A milk-to-plasma concentration ratio of 0.5 was found for oxcarbazepine and MHD