Indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in pediatric patients aged 4 years and above with epilepsy, and as adjunctive therapy in pediatric patients aged 2 years and above with partial seizures.

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

Dose adjustment is recommended for renally impaired patients (CLcr <30 mL/min).

Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of TRILEPTAL.

Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with TRILEPTAL use.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, has occurred with TRILEPTAL.

Testing for the presence of the HLA-B*1502 allele should be considered in patients with ancestry in genetically at-risk populations, prior to initiating treatment with TRILEPTAL. The use of TRILEPTAL should be avoided in patients positive for HLA-B*1502 unless the benefits clearly outweigh the risks.

Antiepileptic drugs (AEDs), including TRILEPTAL, 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.

Use of TRILEPTAL has been associated with central nervous system-related adverse reactions. The most significant of these can be classified into 3 general categories: 1) cognitive symptoms including psychomotor slowing, difficulty with concentration, and speech or language problems, 2) somnolence or fatigue, and 3) coordination abnormalities, including ataxia and gait disturbances.

Exacerbation of or new onset primary generalized seizures has been reported with TRILEPTAL. The risk of aggravation of primary generalized seizures is seen especially in children but may also occur in adults.

Rare reports of pancytopenia, agranulocytosis, and leukopenia have been seen in patients treated with TRILEPTAL during postmarketing experience.

Concurrent use of TRILEPTAL with hormonal contraceptives may render these contraceptives less effective. Studies with other oral or implant contraceptives have not been conducted.

There are no adequate and well-controlled clinical studies of TRILEPTAL in pregnant women; however, TRILEPTAL is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. Data on a limited number of pregnancies from pregnancy registries suggest congenital malformations associated with TRILEPTAL monotherapy use (e.g., craniofacial defects such as oral clefts and cardiac malformations such as ventricular septal defects).

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

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• Adjunctive therapy for partial seizures in pediatric patients under 2 years of age. GoToSource

• Monotherapy for partial seizures in pediatric patients under 4 years of age. GoToSource

• Mania, schizoaffective disorder and bipolar disorder. GoToSource

• Trigeminal neuralgia. GoToSource

• Neuropathic pain. GoToSource

• Alcohol and benzodiazepine withdrawal syndromes, panic and anxiety disorders, dementia, affective disorders and personality disorders. GoToSource

• Autism. GoToSource

• Neuroprotective agent in multiple sclerosis. GoToSource

• Bronchial asthma. GoToSource

• Attention-deficit hyperactivity disorder. GoToSource

• Restless legs syndrome. GoToSource

• Paroxysmal kinesigenic dyskinesia. GoToSource

• Trichotillomania. GoToSource

• Migraines. GoToSource

Stevens-johnson syndrome and toxic epidermal necrolysis (severe skin reaction). GoToSource

Suicidal ideation and behavior. GoToSource

Aggravation of seizures. GoToSource

Hepatic porphyria (group of disorders affecting nervous system or skin). GoToSource

Tardive dyskinesia (involuntary movement disorder). GoToSource

Weight gain. GoToSource

Increased total cholesterol, free thyroxine (hormone produced by thyroid gland) gamma-glutamyl transferase (type of enzyme) and TSH levels (thyroid-stimulating hormone). GoToSource

Diplopia (double vision). GoToSource

Interstitial nephritis (kidney disorder marked by swelling between kidney tubules). GoToSource

West syndrome (severe epilepsy syndrome  marked by infantile spasms, abnormal brain wave patterns and mental retardation). GoToSource

Hyponatraemia (low sodium blood levels). GoToSource

Lawsuits filed for stevens-johnson syndrome and suicidal ideations and behavior.