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| |  Tegretol-XR, New Extended Release Formulation for Epilepsy SUMMIT, N.J., Aug. 20, 1996 -- As the nation's first extended release formulation of an anti-epileptic drug becomes available today, a national survey of persons with epilepsy confirms the need for a medication that offers patients both effectiveness and convenience. Tegretol(R)-XR (carbamazepine extended-release tablets) is a new formulation of Tegretol(R) (carbamazepine), a 25-year-old anti-epileptic drug, that will allow many patients to switch from three or four daily doses to a more convenient twice-daily regimen. Tegretol-XR is indicated as a first-line monotherapy for the treatment of partial, secondarily generalized, and generalized tonic-clonic seizures. The drug received U.S. Food and Drug Administration clearance for marketing in March. "Tegretol-XR addresses an unmet need for thousands of patients with epilepsy who have difficulty complying with their current medication regimen," said John M. Pellock, M.D., Professor of Neurology, Pediatrics and Pharmacy and Pharmaceutics at the Medical College of Virginia of Virginia Commonwealth University in Richmond. A recent survey* conducted last month by the Epilepsy Foundation of America (EFA) funded by a grant from Ciba Pharmaceuticals revealed that a majority (59 percent) of persons with epilepsy sometimes miss taking their medication, with more than half (52 percent) of these persons reporting that missed medication has caused problems for themselves or their families. These persons cited forgetfulness as the most common reason for missed medication (57 percent), with an additional 26 percent attributing missing their medication to a busy lifestyle. Sixty-one percent of these patients say they've talked to their doctor about missing their medication. Moreover, an overwhelming majority (82 percent) of all survey participants say they would be very or somewhat likely to ask their doctor about a new drug for the treatment of epilepsy if they heard one had become available. These survey findings parallel national study data indicating that approximately 30 to 50 percent of patients with epilepsy are noncompliant. Furthermore, in a 1992 survey conducted by Ciba, 91 neurologists and 200 primary care physicians cited noncompliance as a primary reason for breakthrough seizures among their patients taking Tegretol tablets three or four times a day. Furthermore, a study in patients with epilepsy conducted by Joyce Cramer, a nationally recognized compliance expert at Yale, which was reported in the Journal of the American Medical Association, showed that patient compliance improved by 52 percent when dosing frequency of their respective treatment was reduced from four times a day to twice daily. The most frequently observed adverse reactions with Tegretol formulations, 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, 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 patients' plasma levels during conversion to Tegretol-XR or whenever any anticonvulsant therapy formulation is changed. See enclosed package insert for full prescribing information. Tegretol-XR is marketed by Ciba Pharmaceuticals, a division of Ciba-Geigy Corporation (OTC Bulletin Board: CBGXY) of Tarrytown, NY. Ciba is a leading developer and manufacturer of healthcare and agricultural products and specialty 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. * The survey on safety issues, compliance and quality of life was conducted in July 1996 by the Epilepsy Foundation of America (EFA) among a nationally, projectable sample of more than 500 persons with epilepsy who had contacted the organization's toll-free information service.
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