Early in the year 2000, the U.S. Food and Drug Administration gave approval for the use of Trileptal for the treatment of partial seizures in adults and children. According to a statement from the manufacturer, Novartis Pharmaceuticals, the medication is indicated for the treatment of partial seizures as monotherapy in adults or adjunctive therapy (use in combination with other anti-epileptic drugs [AEDs]) in adults and children as young as four years of age.
Trileptal is being studied for use in treating manic-depressive illness. A 2003 study published in the Journal of Clinical Psychiatry concluded, "Oxcarbazepine appeared effective in about one half of patients with bipolar disorder and was well tolerated." However, a study published in the July 2006 issue of the American Journal of Psychiatry found that "Oxcarbazepine is not significantly superior to placebo in the treatment of bipolar disorder in youths."
Warnings and Side EffectsAccording to MedlinePlus, Trileptal can reduce the effectiveness of hormonal birth control medication and may have a potential risk of birth defects, so additional birth control measures should be used by women taking this medication. Be careful with alcohol and sedating medications, since Trileptal may have a sedative effect, and there is the usual warning not to drive or operate heavy machinery until you have gauged your response to this drug.
Oxcarbazepine's most common side effects include dizziness, drowsiness, diplopia (double vision), fatigue, nausea, vomiting, ataxia (being unsteady on your feet), abnormal vision, abdominal pain, tremor, dyspepsia (acid indigestion), and abnormal gait. A fairly rare side effect was hyponatremia (low blood sodium). Symptoms of this condition include not passing much urine, headache, confusion, tiredness and, if very severe, seizures and coma, so contact your doctor if you suspect this may be beginning.
Twenty-five to 30 percent of patients with a known sensitivity to carbamazepine may experience hypersensitivity to Trileptal. These patients should immediately discontinue using Trileptal. Trileptal may interact with certain drugs such as felodipine (Plendil) and verapamil (Covera, Calan, Isoptil, Verelan) - always make sure your doctor knows all medications you are taking.
According to RxList, weight gain was experienced by only one to two percent of patients taking Trileptal in a clinical study where one percent of patients on placebo also gained weight.
Trileptal and PregnancyThe FDA-approved label for Trileptal contains the following caution: "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 [causing birth defects] in humans. Given this fact, and the results of the animal studies described, it is likely that Trileptal is a human teratogen. Trileptal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."
Thus, if you are or plan to become pregnant, it is very important that you discuss your Trileptal use with your doctors, and even ask your obstetrician and the doctor who prescribes Trileptal to consult each other.
Disclaimer: This profile is not intended to be all-inclusive or to replace information provided by your doctor or with the prescription from the manufacturer.
Ghaemi, S.N., et al. Oxcarbazepine treatment of bipolar disorder. Journal of Clinical Psychiatry 64(8)August 2003 934-5. 12/4/06.
Wagner, K.D., et al. A double-blind, randomized, placebo-controlled trial of oxcarbazepine in the treatment of bipolar disorder in children and adolescents. American Journal of Psychiatry 163(7)July 2006 1179-86. 12/4/06.
MedlinePlus. Oxcarbazepine. National Institutes of Health. 2005. 12/4/06.
RxList. Trileptal Side Effects and Drug Interactions. 2006. 12/4/06.
Drugs@FDA. Trileptal Approved Label. US Food and Drug Administration. 23 April 2009. 1 Feb 2009.