Currently Enrolling Trials
Tegretol, an anticonvulsant drug used for more than 25 years in the United States, has received FDA approval for use in children under six years of age. Tegretol is indicated as a first-line monotherapy for the treatment of partial, secondarily generalized, and generalized tonic-clonic seizures in children and adults. The medication is available in scored tablets, chewable tablets, and liquid suspension forms.
Tegretol-XR has been approved as a treatment for epileptic seizures. It is a new formulation that will allow many subjects to switch from three or four daily doses to a more convenient twice-daily regimen. Available only by prescription in 100 mg, 200 mg, and 400 mg tablets, Tegretol-XR is indicated as a first-line monotherapy for the treatment of partial, secondarily generalized, and generalized tonic-clonic seizures.
The safety of carbamazepine in children has systemically been studied in clinical trials up to six months. Longer-term data is not available.
The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. Although reports of transient or persistent decreased platelet or white blood cell counts are not uncommon in association with the use of Tegretol, the vast majority of cases of leukopenia have not progressed to the more serious conditions of aplastic anemia or agranulocytosis.
Epileptic seizures are caused by a sudden and unusual discharge of electrical energy in the brain. It is estimated that 13%--or more than 300,000--of the 2.5 million Americans with epilepsy are children under the age of 18, according to the Epilepsy Foundation of America. Twenty-five percent of all cases develop before the child reaches the age of five.