Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Neurology | Pediatrics/Neonatology | Family Medicine | Genetic Disease
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Ciba Pharmaceuticals
Approval Status: Approved March 1996
Treatment Area: epilepsy
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.
The safety of carbamazepine in children has systemically been
studied in clinical trials up to six months. Longer-term data is
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.