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HOW SUPPLIED IMITREX Tablets, 25, 50, and 100 mg of sumatriptan (base) as the succinate. IMITREX Tablets, 25 mg are white, triangular-shaped, film-coated tablets debossed with "I" on one side and "25" on the other in blister packs of 9 tablets (NDC 0173-0735-00).
IMITREX Tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with "IMITREX 50" on one side and a chevron shape (
^ ) on the other in blister packs of 9 tablets (NDC 0173-0736-01). Text Continues Below
IMITREX Tablets, 100 mg, are pink, triangular-shaped, film-coated tablets debossed with "IMITREX 100" on one side and a chevron shape ( ^ ) on the other in blister packs of 9 tablets (NDC 0173-0737-01). Store between 36° and 86° F (2° and 30° C). ANIMAL TOXICOLOGY Corneal Opacities: Dogs receiving oral sumatriptan developed corneal opacities and defects in the corneal epithelium. Corneal opacities were seen at the lowest dosage tested, 2 mg/ kg/ day, and were present after 1 month of treatment. Defects in the corneal epithelium were noted in a 60-week study. Earlier examinations for these toxicities were not conducted and no-effect doses were not established; however, the relative exposure at the lowest dose tested was approximately 5 times the human exposure after a 100-mg oral dose. There is evidence of alterations in corneal appearance on the first day of intranasal dosing to dogs. Changes were noted at the lowest dose tested, which was approximately one half the maximum single human oral dose of 100 mg on a mg/ m 2 basis. Page: << Prev | 1 | 2
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