Tegretol (carbamazepine USP)
Company: Ciba Pharmaceuticals
Approval Status: Approved March 1996
Treatment for: epilepsy
Areas: Neurology; Pediatrics/Neonatology
| General Information | Clinical Results | Side Effects | Additional Information |
General Information
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.
Clinical Results
The safety of carbamazepine in children has systemically been studied in clinical trials up to six months. Longer-term data is not available.
Side Effects
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.
Additional Information
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.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
