Trade Name: FLUOROURACIL

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Spear Dermatology Products

Presentation: CREAM, HUMAN PRESCRIPTION DRUG

Strength: 50 mg/g

Storage and handling

FLUOROURACIL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • Fluorouracil Cream, USP 5% is a topical preparation containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite. Fluorouracil Cream contains 5% fluorouracil in a vanishing cream base consisting of white petrolatum, cetyl alcohol, stearyl alcohol, propylene glycol, polysorbate 60, parabens (methyl and propyl), and purified water.
  • Chemically, fluorouracil is 5-fluoro-2,4(1,3)-pyrimidinedione. It is a white to practically white, crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol. The molecular weight of 5-fluorouracil is 130.08 and the structural formula is:
  • 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 which provokes unbalanced growth and death of the cell. The effects of DNA and RNA deprivation are most marked on those cells which grow more rapidly and take up fluorouracil at a more rapid rate. The catabolic metabolism of fluorouracil results in degradation products (e.g., CO, urea, u03b1-fluoro-u03b2-alanine) which are inactive.
  • Systemic absorption studies of topically applied fluorouracil have been performed on patients with actinic keratoses using tracer amounts of C-labeled fluorouracil added to a 5% preparation. All patients had been receiving nonlabeled fluorouracil until the peak of the inflammatory reaction occurred (2 to 3 weeks), ensuring that the time of maximum absorption was used for measurement. One gram of labeled preparation was applied to the entire face and neck and left in place for 12 hours. Urine samples were collected. At the end of 3 days, the total recovery ranged between 0.48% and 0.94% with an average of 0.76%, indicating that approximately 5.98% of the topical dose was absorbed systemically. If applied twice daily, this would indicate systemic absorption of topical fluorouracil to be in the range of 5 to 6 mg per daily dose of 100 mg. In an additional study, negligible amounts of labeled material were found in plasma, urine and expired CO after 3 days of treatment with topically applied C-labeled fluorouracil.
  • 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 defect (cleft lip and palate) has been reported in the newborn of a patient using Fluorouracil Cream as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when Fluorouracil Cream 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 Cream. 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 ). 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 (ie, 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 Cream 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 Cream 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 Cream is also contraindicated in patients with known hypersensitivity to any of its components.
  • Application to mucous membranes should be avoided due to the possibility of local inflammation and ulceration. Additionally, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when Fluorouracil Cream was applied to mucous membrane areas during pregnancy.
  • Occlusion of the skin with resultant hydration has been shown to increase percutaneous penetration of several topical preparations. If any occlusive dressing is used in treatment of basal cell carcinoma, there may be an increase in the severity of inflammatory reactions in the adjacent normal skin. A porous gauze dressing may be applied for cosmetic reasons without increase in reaction.
  • Exposure to ultraviolet rays should be minimized during and immediately following treatment with Fluorouracil Cream because the intensity of the reaction may be increased.
  • Patients should discontinue therapy with Fluorouracil Cream if symptoms of DPD enzyme deficiency develop (see section).
  • Rarely, life-threatening toxicities such as stomatitis, diarrhea, neutropenia, and neurotoxicity have been reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency. One case of life-threatening systemic toxicity has been reported with the topical use of Fluorouracil Cream in a patient with DPD enzyme deficiency. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the esophagus, stomach, and small bowel. Although this case was observed with 5% fluorouracil cream, it is unknown whether patients with profound DPD enzyme deficiency would develop systemic toxicity with lower concentrations of topically applied fluorouracil.
  • No data
  • The most frequent adverse reactions to Fluorouracil Cream occur locally and are often related to an extension of the pharmacological activity of the drug. These include burning, crusting, allergic contact dermatitis, erosions, erythema, hyperpigmentation, irritation, pain, photosensitivity, pruritus, scarring, rash, soreness and ulceration. Ulcerations, other local reactions, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when Fluorouracil Cream was applied to mucous membrane areas. Leukocytosis is the most frequent hematological side effect. Although a causal relationship is remote, other adverse reactions which have been reported infrequently are:
  • Central Nervous System:
  • Gastrointestinal:
  • Hematological:
  • Integumentary:
  • Special Senses:
  • Miscellaneous:
  • To report SUSPECTED ADVERSE REACTIONS contact Spear Dermatology Products at 1-866-SPEAR-RX (773-2779) or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.
  • There have been no reports of overdosage with Fluorouracil Cream.
  • The oral LD for the 5% topical cream was 234 mg/kg in rats and 39 mg/kg in dogs. These doses represented 11.7 and 1.95 mg/kg of fluorouracil, respectively. The topical application of the 5% cream to rats yielded an LD of greater than 500 mg/kg.
  • When Fluorouracil Cream is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization.
  • Fluorouracil Cream should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil Cream is applied with the fingers, the hands should be washed immediately afterward.
  • Actinic or Solar Keratosis:
  • Superficial Basal Cell Carcinomas: n- Only the 5% strength is recommended.
  • Fluorouracil Cream, USP 5% is available in 40 g tubes containing 5% fluorouracil (NDC 66530-249-40) in a vanishing cream base consisting of white petrolatum, cetyl alcohol, stearyl alcohol, propylene glycol, polysorbate 60, parabens (methyl and propyl), and purified water.
  • Store at 20 - 25u00b0C (68 - 77u00b0F) [See USP Controlled Room Temperature].
  • Manufactured by: Rockledge Pharmaceutical Manufacturing, LLCRockledge, FL 32955
  • Distributed by: Spear Dermatology Products Randolph, NJ 07869 n SPI5FU4R3
  • Rev. 11-2016
  • Ingrediants:
  • Apply preferably with a nonmetal applicator or suitable glove.
  • NDC 66530-249-40
  • Fluorouracil Cream, USP 5%
  • FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
  • 40 g u00a0u00a0u00a0Rx Only
  • SPP5FU4R2 u00a0u00a0u00a0Rev. 07-2017
  • Usual Dosage:
  • Store at 20 - 25u00b0C (68 - 77u00b0F) [See USP Controlled Room Temperature].
  • FOR EXTERNAL USE ONLY
  • Manufactured by: Rockledge Pharmaceutical Manufacturing, LLC, Rockledge, FL 32955
  • Distributed by: Spear Dermatology Products, Randolph, NJ 07869
  • NDC 66530-249-40
  • Fluorouracil Cream, USP 5%
  • FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
  • 40 g u00a0u00a0u00a0Rx Only
  • Ingrediants:
  • Usual Dosage:
  • Store at 20 - 25u00b0C (68 - 77u00b0F) [See USP Controlled Room Temperature].
  • Lot No. and expiration date appear on crimp of tube.
  • Manufactured by: Rockledge Pharmaceutical Manufacturing, LLC, Rockledge, FL 32955
  • Distributed by: Spear Dermatology Products, Randolph, NJ 07869
  • SPT5FU4R1 u00a0u00a0u00a0Rev. 11-2016
  • FOR EXTERNAL USE ONLY
  • TO OPEN:

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of fluorouracil (FLUOROURACIL) which is also known as FLUOROURACIL and Manufactured by Spear Dermatology Products. It is available in strength of 50 mg/g.

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