Oxcarbazepine (generic)

Trileptal (brand)

Classification: Anticonvulsant.

Common usage: Oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures (a subtype of epilepsy) in adults, as monotherapy in the treatment of partial seizures in children ages 4 years and older with epilepsy, and as adjunctive therapy in children ages 2 years and older with epilepsy.

Warnings and precautions:

Suicidal behavior and ideation: Antiepileptic drugs (AEDs), including oxcarbazepine, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Hyponatremia: Clinically significant hyponatremia (low blood sodium, <125 mmol/L) can develop during oxcarbazepine use. Measurement of serum sodium levels should be considered for patients during maintenance treatment, particularly if the patient is receiving other medications known to decrease serum sodium levels (for example, drugs associated with inappropriate antidiuretic hormone secretion) or if symptoms possibly indicating hyponatremia develop (e.g., nausea, malaise, headache, lethargy, confusion, reduction in alertness, or increase in seizure frequency or severity).

Anaphylaxis and angioedema: Anaphylaxis (severe allergic reaction) and angioedema (swelling) involving the throat, lips, and eyelids have been reported in patients taking oxcarbazepine. If any such reaction occurs, you should discontinue use of oxcarbazepine.

Serious dermatological reactions: Serious skin reactions, such as Stevens-Johnson syndrome, have been reported in association with oxcarbazepine.

Past history of hypersensitivity reaction to carbamazepine: Of patients who have had hypersensitivity to carbamazepine, 25% to 30% will experience a reaction to oxcarbazepine. Caution should be used in prescribing oxcarbazepine for these patients.

Important side effects: During research studies, oxcarbazepine has been reported to cause problems with balance, shaking, clumsiness, unsteadiness, or dizziness. Potential vision problems include double vision, blurry vision, or uncontrolled side-to-side or rotating movements of the eye that are usually not noticed by the patient as much as someone looking at the patient. Other possible adverse effects include changes in mood, agitation, confusion, disorientation, memory problems, or loss of consciousness. Cough, sore throat, shortness of breath, wheezing, difficulty breathing, or sinus infection also may occur. Other possible effects include easy bruising, fever, decreased urination or increased thirst, fast or irregular heartbeat, muscle cramps, and low blood pressure, including faintness or lightheadedness when getting up from a lying or sitting position.

This is not a complete list of all known or potential adverse effects. Notify your prescriber or pharmacist of any symptoms that have started since you began taking this medication, changing its dose, or adding or changing other medication or diet. Take care when performing any task that requires your attention (such as driving or operating machinery) until you have experience with this drug and are confident you can perform the task safely.

Interactions with other medications: Drugs that can reduce the effect of oxcarbazepine include other anticonvulsants such as carbamazepine (Tegretol), phenobarbital (Luminal), phenytoin (Dilantin), and valproate (Depakene, Depakote). Oxcarbazepine can reduce the effectiveness of oral contraceptives and some cardiac medications, such as felodipine (Plendil) or verapamil (Calan).

This is not a complete list of all known or potential drug interactions. To help prevent problems, always make sure that your pharmacist and all prescribers know about all medications you are taking, including over-the-counter drugs; dietary herbal supplements; folk or home remedies; or unusual foods, drinks, or dietary habits.

Common dosages: The usual initial adult dose when oxcarbazepine is used as monotherapy is 300 mg twice daily, which may be increased by 300 mg daily at three-day intervals to a maximum daily dose of 1,200 mg. The dose may be increased by a maximum of 600 mg daily at weekly intervals if adding to or converting from another anticonvulsant. Some patients may benefit from higher doses up to 2,400 mg daily, but adverse effects increase at higher doses.

If a dose is missed, it should be taken as soon as possible unless it is almost time for the next dose; in that case, skip the missed dose and resume your routine schedule. Do not take a double dose.

In pediatric patients ages 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg per kg, generally not to exceed 600 mg per day, given in a twice-daily regimen.

Identification: The 150-mg tablets of oxcarbazepine are yellow, film-coated, ovaloid, slightly biconvex, and scored on both sides, and are imprinted with “T/D” on one side and “C/G” on the other. The 300-mg tablets are yellow, film-coated, ovaloid, slightly biconvex, and scored on both sides, and are imprinted with “TE/TE” on one side and “CG/CG” on the other. The 600-mg tablets are yellow, film-coated, ovaloid, slightly biconvex, and scored on both sides, and are imprinted with “TF/TF” on one side and “CG/CG” on the other. Oxcarbazepine is also available as a 300 mg/5 mL (60 mg/mL) oral suspension that is off-white to slightly brown or slightly red in color.

Storage: Store this medication at normal room temperature (59°F to 86°F) in a tightly closed, child-, light-, and moisture-resistant container. If you have difficulty opening child-resistant containers, your pharmacist can provide you with a container that is easier to open. Keep the medication out of direct sunlight and avoid storing it in a warm and humid area, such as the bathroom or kitchen, to avoid deterioration. To prevent accidental poisoning, keep all medications out of the reach of children or adults with dementia. Do not take expired medication. Do not transfer medication from one container to another. Carefully discard discontinued medication where children or adults with dementia cannot find it.