Business Wire - Tegretol®-XR receives clearance for marketing
SUMMIT, N.J.–(HealthWire)–May 2, 1996–Ciba-Geigy Corp. announced today that Tegretol(R)-XR (carbamazepine extended-release tablets), the first extended release anti-epileptic drug, recently received U.S. Food and Drug Administration clearance for marketing.
“Tegretol is a medication that physicians and patients have trusted for more than 25 years,” said Ron Califre, senior vice president, Medicine and Clinical Development for Ciba. “Tegretol-XR represents, for many patients, the chance to switch to a more convenient dosing schedule.”
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Tegretol-XR is a new formulation of Tegretol that will allow many patients to switch from 3 or 4 daily doses to a more convenient twice-daily regimen. Available only by prescription in 100mg, 200mg and 400mg tablets, Tegretol-XR is indicated as a first-line monotherapy for the treatment of partial, secondarily generalized, and generalized tonic-clonic seizures. It is expected to be available in August.
The most frequently observed adverse reactions with Tegretol-XR therapy - particularly during the initial phases of therapy - are dizziness, drowsiness, unsteadiness, nausea and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest possible dose. Although reports of transient or persistent decreased platelet or white blood cells 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. When initiating therapy with Tegretol-XR, physicians should obtain complete pretreatment hematologic testing as a baseline. As with all anticonvulsant therapy, periodic hematologic evaluations are recommended at the physician’s discretion. Physicians should monitor patient’s plasma levels during conversion to Tegretol-XR or whenever any anticonvulsant therapy formulation is changed.
Tegretol-XR will be marketed by CibaGeneva Pharmaceuticals, a marketing alliance between Ciba-Geigy Corp. of Tarrytown, N.Y., and the corporation’s wholly-owned subsidiary, Geneva Pharmaceuticals, Inc. Ciba is a leading developer and manufacturer of healthcare and agricultural products and speciality chemicals for industry. Ciba is dedicated to discovering, developing, manufacturing and marketing innovative pharmaceuticals that meet unmet medical needs and improve patients’ quality of life. The company has been dedicated to research, drug development and continuing education in the neurosciences for more than 25 years. -0- Note to Editors: Full prescribing information is available by calling 908/277-5758.
CONTACT: Ciba Public Relations
Doug Arbesfeld, 908/277-5758
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