Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
fluorouracil (UNII: U3P01618RT) (fluorouracil - UNII:U3P01618RT)
Spear Dermatology Products Inc
fluorouracil
fluorouracil 5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Fluououracil cream 0.5% is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp. Fluorouracil may cause fetal harm when administered to a pregnant woman. Fluorouracil is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. No adequate and well-controlled studies have been conducted in pregnant women with either topical or parenteral forms of fluorouracil. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when fluorouracil was applied to mucous membrane areas. Multiple birth defects have been reported in the fetus of a patient treated with intravenous fluorouracil. Animal reproduction studies have not been conducted with fluorouracil cream 0.5%. Fluorouracil, the active ingredient, has been shown to be teratogenic in mice, rats, and hamsters when adm
Cream - 30 gram tube NDC 66530-258-30 Store at Controlled Room Temperature 20 to 25° C (68 to 77° F) [see USP]. Keep out of the reach of children.
New Drug Application Authorized Generic
FLUOROURACIL- FLUOROURACIL CREAM SPEAR DERMATOLOGY PRODUCTS INC ---------- FLUOROURACIL CREAM, 0.5% FOR TOPICAL DERMATOLOGICAL USE ONLY (NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE) DESCRIPTION Fluorouracil cream 0.5%, contains fluorouracil for topical dermatologic use. Chemically, fluorouracil is 5-fluoro-2,4(1H, 3H)-pyrimidinedione. The molecular formula is C H FN O . Fluorouracil has a molecular weight of 130.08. Fluorouracil cream contains 0.5% fluorouracil, with 0.35% being incorporated into a patented porous microsphere (Microsponge ) composed of methyl methacrylate/glycol dimethacrylate crosspolymer and dimethicone. The cream formulation contains the following other inactive ingredients: Carbomer Homopolymer Type C, dimethicone, glycerin, methyl gluceth-20, methyl methacrylate/glycol dimethacrylate crosspolymer, methylparaben, octyl hydroxy stearate, polyethylene glycol 400, polysorbate 80, propylene glycol, propylparaben, purified water, sorbitan monooleate, stearic acid, and trolamine. CLINICAL PHARMACOLOGY There is evidence that the metabolism of fluorouracil in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this manner, fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA). Since DNA and RNA are essential for cell division and growth, the effect of fluorouracil may be to create a thymine deficiency that provokes unbalanced growth and death of the cell. The effects of DNA and RNA deprivation are most marked on those cells that grow more rapidly and take up fluorouracil at a more rapid rate. The contribution to efficacy or safety of individual components of the vehicle has not been established. PHARMACOKINETICS A multiple-dose, randomized, open-label, parallel study was performed in 21 patients with actinic keratoses. Twenty patients had pharmacokinetic samples collected: 10 patients treated with fluorouracil cream 0.5% and 10 treated with Efudex 5% Cream. Patie Belgenin tamamını okuyun