Oxcarbazepine

Oxcarbazepine is an anticonvulsant, or antiepileptic drug, used to treat partial seizures in adults and children who are at least 2 years old.

Oxcarbazepine is available under the following different brand names: Trileptal, and Oxtellar XR.

Dosage Forms and Strengths

Tablet

• 150 mg
• 300 mg
• 600 mg

Tablet, extended-release

• 150 mg
• 300 mg
• 600 mg

Oral suspension

• 300 mg/5 mL

Common side effects of oxcarbazepine include:

• Dizziness
• Double vision/blurred vision
• Vision abnormalities
• Headache
• Nausea
• Vomiting
• Drowsiness
• Loss of control of bodily movements
• Problems with speech, balance, or walking
• Shaking (tremor)
• Upset stomach
• Fatigue
• Spinning sensation (vertigo)
• Indigestion
• Skin rash
• Trouble sleeping (insomnia)
• Abnormal thinking
• Mental slowness
• Low blood sodium (hyponatremia)
• Muscle weakness
• Low blood pressure (hypotension)
• Speech disorder
• Lack of energy
• Tired feeling
• Diarrhea
• Trouble concentrating
• Acne
• Dry mouth
• Constipation

Serious side effects of oxcarbazepine include:

• Changes in vision
• Involuntary, repetitive eye movements
• Difficulty speaking
• Difficulty concentrating
• Loss of coordination
• Trouble walking (abnormal gait)
• Dulled sense of touch
• Easy bleeding or bruising
• Chest pain
• Persistent sore throat
• Stomach or abdominal pain
• Bloody stool
• Dark urine
• Changes in amount of urine
• Yellowing of eyes or skin

Postmarketing side effects of oxcarbazepine reported include:

• Skin swelling
• Severe allergic reaction (anaphylaxis)
• Multi-organ 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: Multi-organ hypersensitivity disorders characterized by features such as rash, fever, enlarged lumph nodes, abnormal liver function tests, eosinophilia, and joint pain

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Oxcarbazepine has severe interactions with at least 21 different drugs.
• Oxcarbazepine has serious interactions with at least 62 different drugs.
• Oxcarbazepine has moderate interactions with at least 141 different drugs.
• Oxcarbazepine has mild interactions with at 94 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains oxcarbazepine. Do not take Trileptal or Oxtellar XR if you are allergic to oxcarbazepine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Oxcarbazepine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Oxcarbazepine?"

Cautions

See FDA warning on potential suicidal behavior; monitor patients for notable changes in behavior that might be associated with suicidal thoughts or depression (notify health-care provider immediately if symptoms occur).

Caution performing tasks that require mental alertness.

Potentially fatal skin reactions may occur (e.g., Stevens-Johnson syndrome).

May render oral contraceptives ineffective because of metabolic enzyme induction. May reduce efficacy of oral contraceptives; additional contraceptive measures recommended.

Discontinue if dermatological reactions occur.

Significant low blood sodium (hyponatremia) may develop (monitor especially in patients at risk of hyponatremia).

Pancytopenia, agranulocytosis, and leukopenia reported rarely.

Long term use has been associated with decreased mineral density, osteopenia, osteoporosis, and fractures, central nervous system (CNS)-related adverse effects including difficulty with concentration, psychomotor slowing, speech or language problems, somnolence or fatigue, coordination of abnormalities, including loss of control of bodily movements and gait disturbances

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 less than 30 mL/min; adjust dose in these patients.

Do not discontinue anticonvulsants abruptly.

Drug reaction with eosinophilia and systemic symptoms (DRESS)

• Drug reaction with eosinophilia and systemic symptoms (DRESS), also known as multi-organ hypersensitivity, reported
• Some of these events have been fatal or life-threatening
• DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement (e.g., hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis), sometimes resembling an acute viral infection

Pregnancy and Lactation

Use oxcarbazepine with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.

Due to physiologic changes during pregnancy, plasma levels of the active metabolite of oxcarbazepine, MHD, may gradually decrease throughout pregnancy.

Oxcarbazepine and its active metabolite (MHD) are excreted in human milk; milk-to-plasma concentration ratio of 0.5 was found for both. Because of the potential for serious adverse reactions in nursing infants, a decision should be made as to whether a mother should discontinue nursing or whether she should discontinue use of the drug, taking into account the drug's importance to the mother.