Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
FLUOROURACIL (UNII: U3P01618RT) (FLUOROURACIL - UNII:U3P01618RT)
Pierre Fabre Pharmaceuticals, Inc.
FLUOROURACIL
FLUOROURACIL 40 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. Tolak Cream is contraindicated: - During pregnancy [see Warnings and Precautions (5.5, 8.1)] - In patients with dihydropyrimidine dehydrogenase (DPD) deficiency [see Warnings and Precautions (5.6)] Tolak Cream may cause fetal harm when administered during pregnancy and is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus. Tolak Cream is contraindicated in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Teratogenic Effects: Pregnancy Category X [see Contraindications (4.1)] . Cases of miscarriage and birth defects (including cleft lip and cleft palate) have been reported wh
Tolak (fluorouracil) Cream, 4% containing 40 mg of fluorouracil per gram of white cream is available in a 40 gram tube (NDC 64370-421-40). Store at 25°C (77°F), with excursion permitted from 15°C to 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Do not freeze.
New Drug Application
TOLAK- FLUOROURACIL CREAM PIERRE FABRE PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOLAK CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOLAK CREAM. TOLAK (FLUOROURACIL) CREAM, 4%, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1962 INDICATIONS AND USAGE Tolak (fluorouracil) Cream, 4%, is a nucleoside metabolic inhibitor indicated for the topical treatment of actinic keratosis lesions of the face, ears, and scalp ( 1). DOSAGE AND ADMINISTRATION Apply Tolak Cream after washing, rinsing, and drying the treatment area(s) ( 2). Apply Tolak Cream once daily in an amount sufficient to cover the lesions of the face, ears, and/or scalp with a thin film, using the fingertips to gently massage the medication uniformly into the skin ( 2). Tolak Cream should be applied for a period of 4 weeks as tolerated ( 2). Wash hands thoroughly following Tolak Cream application ( 2). Tolak Cream is for topical use only. Do not apply to eyes, nose, mouth or mucous membranes ( 2). Not for ophthalmic, oral, or intravaginal use ( 2). DOSAGE FORMS AND STRENGTHS Cream: 40 mg of fluorouracil per gram of cream (4%) ( 3). CONTRAINDICATIONS Pregnancy ( 4.1, 8.1). Dihydropyrimidine dehydrogenase (DPD) deficiency ( 4.2). WARNINGS AND PRECAUTIONS Application site adverse reactions are likely to occur during and for 4 weeks after treatment of actinic keratosis with Tolak Cream ( 5.1). Hypersensitivity reactions may occur with Tolak Cream ( 5.2). Avoid treatment in the periocular area. Eye disorders, including corneal reactions have occurred with topical fluorouracil use. Avoid accidental transfer of the drug into eyes and to the periocular area. If accidental exposure occurs, seek medical care ( 5.3). Increased sensitivity to ultraviolet light may occur during and immediately after treatment with Tolak Cream ( 5.4). Fluorouracil may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective co Pročitajte cijeli dokument