Carbatrol (carbamazepine) extended-release capsules.BOXED WARNING Serious Dermatologic Reactions and HLA-B*1502 Allele allele (əlēl`): see genetics. allele Any one of two or more alternative forms of a gene that may occur alternatively at a given site on a chromosome. Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis Toxic Epidermal Necrolysis Definition Toxic epidermal necrolysis is a rare condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below. A reaction to a medication is the primary cause. (TEN) and Stevens-Johnson Syndrome (SJS SJS Stevens Johnson Syndrome (medical) SJS San Jose Sharks SJS St Joseph's School (Ifugao, Philippines) SJS Schwartz-Jampel Syndrome SJS San Jose Scale SJS Secretary, Joint Staff ), have been reported during treatment with carbamazepine carbamazepine /car·ba·maz·e·pine/ (kahr?bah-maz´e-pen) an anticonvulsant and analgesic used in the treatment of pain associated with trigeminal neuralgia and in epilepsy manifested by certain types of seizures. . These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly caucasian populations, but the risk in some Asian countries is estimated to be about 10 times higher. Studies in patients of Chinese ancestry have found a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic al·lele n. One member of a pair or series of genes that occupy a specific position on a specific chromosome. [German Allel, short for Allelomorph, allelomorph, from English variant of the HLA-B gene. HLA-B*1502 is found almost exclusively in patients with ancestry across broad areas of Asia. Patients with ancestry in genetically at risk populations should be screened for the presence of HLA-B*1502 prior to initiating treatment with Carbatrol. Patients testing positive for the allele should not be treated with Carbatrol unless the benefit clearly outweighs the risk (see WARNINGS and PRECAUTIONS/Laboratory Tests). WARNINGS Serious Dermatologic Reactions SJS/TEN and HLA-B*1502 Allele PRECAUTIONS Laboratory Tests |
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