United States - English - NLM (National Library of Medicine)

mayne pharma inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil cream is recommended for the topical treatment of multiple actinic or solar keratoses. in the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. safety and efficacy in other indications have not been established. the diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. with isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. the success rate with fluorouracil cream is approximately 93%, based on 113 lesions in 54 patients. eighty-eight lesions treated with the cream produced 7 failures. fluorouracil cream may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. one birth defe

United States - English - NLM (National Library of Medicine)

northstar rx llc - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. in the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. safety and efficacy in other indications have not been established. the diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. with isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. the success rate with fluorouracil cream and solution is approximately 93%, based on 113 lesions in 54 patients. twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures. fluorouracil may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies in pregnant women with either the top

United States - English - NLM (National Library of Medicine)

accord healthcare inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil cream usp is recommended for the topical treatment of multiple actinic or solar keratoses. in the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. safety and efficacy in other indications have not been established. the diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. with isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. the success rate with fluorouracil cream usp is approximately 93%, based on 113 lesions in 54 patients. eighty-eight lesions treated with the cream produced 7 failures. fluorouracil cream may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. one bi

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil cream usp is recommended for the topical treatment of multiple actinic or solar keratoses. in the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. safety and efficacy in other indications have not been established. the diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. with isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. the success rate with fluorouracil cream usp is approximately 93%, based on 113 lesions in 54 patients. eighty-eight lesions treated with the cream produced 7 failures. fluorouracil cream may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. one bi

United States - English - NLM (National Library of Medicine)

encube ethicals private limited - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. in the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. safety and efficacy in other indications have not been established. the diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. with isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. the success rate with fluorouracil solution and a different dosage form is approximately 93%, based on 113 lesions in 54 patients. twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with a different dosage form produced 7 failures. fluorouracil may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. one birth defect (cleft lip and palate) has been reported in the newborn of a patient using fluorouracil as recommended. 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 a fetus of a patient treated with intravenous fluorouracil. animal reproduction studies have not been conducted with fluorouracil. fluorouracil administered parenterally has been shown to be teratogenic in mice, rats, and hamsters when given at doses equivalent to the usual human intravenous dose; however, the amount of fluorouracil absorbed systemically after topical administration to actinic keratoses is minimal (see clinical pharmacology ). fluorouracil exhibited maximum teratogenicity when given to mice as single intraperitoneal injections of 10 to 40 mg/kg on day 10 or 12 of gestation. similarly, intraperitoneal doses of 12 to 37 mg/kg given to rats between days 9 and 12 of gestation and intramuscular doses of 3 to 9 mg/kg given to hamsters between days 8 and 11 of gestation were teratogenic and/or embryotoxic (i.e., resulted in increased resorptions or embryolethality). in monkeys, divided doses of 40 mg/kg given between days 20 and 24 of gestation were not teratogenic. doses higher than 40 mg/kg resulted in abortion. fluorouracil should not be used in patients with dihydropyrimidine dehydrogenase (dpd) enzyme deficiency. a large percentage of fluorouracil is catabolized by the dpd enzyme. dpd enzyme deficiency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities. fluorouracil is contraindicated in women who are or may become pregnant during therapy. 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. fluorouracil is also contraindicated in patients with known hypersensitivity to any of its components.

United States - English - NLM (National Library of Medicine)

spear dermatology products - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 5 mg in 1 g

United States - English - NLM (National Library of Medicine)

accord healthcare, inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil is indicated for the treatment of patients with: none. pregnancy category d risk summary there are no adequate and well-controlled studies with fluorouracil in pregnant women. based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity. malformations included cleft palate and skeletal defects. in monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see clinical pharmacology (12.1)] . animal data malformations including cleft palate, skeletal defects and deformed appendages (paws and tails) were observed when fluorouraci

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - fluorouracil 50 mg/ml - solution for injection - 50 mg/ml - active: fluorouracil 50 mg/ml excipient: nitrogen sodium hydroxide water for injection - alone or in combination, for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas. fluorouracil should only be used when other proven measures have failed or are considered impractical.

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 ml

United States - English - NLM (National Library of Medicine)

pierre fabre pharmaceuticals, inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 40 mg in 1 g - 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