Model:7501122900795
Current Reviews:0
Price:$67.00
Generic name: Fluorouracil.
Pharmaceutical form: Cream. 20g contain: 5 g fluorouracil. Excipient qs 100 g.
Therapeutic indications: Skin Disorders: treatment of actinic keratosis, Bowen's disease, superficial basal cell epithelioma, epidermodisplasia verruciforme, common warts, Keratoacanthomas, warts and / or papillomas. Specifically indicated in lesions whose location or size difficult surgical treatment. Aid in the treatment of psoriasis of the nails. Usually EFUDIX® not act on squamous epithelioma. Gynecological and urological: lesions caused by human papillomavirus: warts and / or papillomas.
Cervix: squamous intraepithelial lesion low grade (mild dysplasia CIN-1). Vagina: vaginal intraepithelial neoplasia (mild dysplasia NIVA-I, moderate dysplasia NIVA-II, severe dysplasia NIVA-III). vaginal and vulvar condyloma and genital warts (vulva, perianal area, penis and meatus).
Pharmacokinetics: EFUDIX® acts as an antimetabolite by interfering with the synthesis of DNA and RNA by inhibiting thymidylate synthetase. Thymidylate synthase catalyses the methylation deoxiuridílico acid to thymidylic acid, a precursor of DNA. It is estimated that the systemic absorption of 5-fluorouracil administered topically can be up to 10% of the applied dose, but absorption through mucosa may be greater, as with other drugs. With topical application of EFUDIX®, 5.050 to 27.200 Cmax ng / ml Tmax of from 0.999 to 1.075 hours and an AUC of 14,507 it was observed to 37.518 ng • hr / ml. Administered systemically, it is known to be metabolized in the liver. Of the administered IV dose, 15% is excreted in the urine as unchanged drug within 6 h. 90% of it is eliminated in the first hour. The metabolites are excreted as carbon dioxide by airways and urine as urea, a-fluoro-b-alanine, fluoro-a-b- guanidopropiónico and .alpha.-fluoro-b- ureidopropionic.
Contraindications: Hypersensitivity to the components of the formula. should not apply in his eyes. Do not apply during pregnancy. EFUDIX® should not be used in patients with dihydropyrimidine dehydrogenase deficiency, which catabolized to fluorouracil, because it can cause severe poisoning.
Precautions: EFUDIX®, when applied in large ulcerated areas of skin, can support the systemic absorption and thus the production of cytotoxic effects, such as bone marrow depression. exposure to sunlight or UV radiation sources should be avoided, since the treatment increases the sensitivity to light. If the patient has systemic involvement as neutropenia, cerebellar dysfunction or after application of EFUDIX® neurotoxicity, consider a dihydropyrimidine dehydrogenase deficiency, which can be diagnosed by the finding of high concentrations of uracil and thymine urine.
Restrictions on use during pregnancy and lactation: Do not use during pregnancy. It is not known so far whether fluorouracil is distributed into milk; it is recommended that lactating women in the suspension while receiving treatment or postpone its application.
Adverse Reactions: EFUDIX® can redden the healthy part surrounding the lesion; this reaction ceases rapidly after stopping treatment. Most adverse reactions are presented locally and depend on the areal extent and duration of treatment. These include irritation, erythema, erosion, swelling, itching, discharge, rash, hyperpigmentation, crusting, contact dermatitis, pain, photosensitivity and ulceration. Gynecological erythema, erosion, ulceration and abnormal genital runoff.
Drug Interactions: To date not known.
Changes in laboratory test results: At the recommended dose, no changes occur.
Precautions regarding effects of carcinogenicity, mutagenicity, teratogenicity and fertility: In animals, it has shown to be teratogenic at doses 1-3 times higher than the recommended maximum. Although to date there is no evidence of teratogenicity in humans caused by fluorouracil, teratogenicity has been reported by other medicinal products that inhibit DNA synthesis; therefore, its use is contraindicated in pregnancy. Fluorouracil has been shown to be mutagenic in some strains of S. typhimurium and S. cerevisiae.
It was also mutagenic in the micronucleus test in bone marrow cells of mice, and in vitro at very high concentrations in hamster fibroblasts chromosomal breakage occurred. Although the risk of mutagenesis in patients receiving fluorouracil has not been evaluated, you should consider. There are no studies to determine the drug's effects on fertility when administered topically. There have been no long-term studies in animals to determine the carcinogenic potential; however, no evidence of carcinogenicity has been observed in various animal studies by administering the drug orally or intravenously for up to 1 year.
Dosage and administration: In actinic keratoses, 1 or 2 daily applications of a thin layer without occlusive patch must be made during 2-4 weeks to ulceration. In superficial basal cell epithelioma, apply 1-2 times a day; Treatment is continued until the stage of ulceration. The duration of treatment in principle is 3 to 6 weeks. In warts, apply EFUDIX® night and cover with occlusive patch; the next morning, wash. Repeat the procedure every other day for a period of 2-3 weeks. In plantar warts, it is recommended that prior to the implementation of dermabrasion EFUDIX®. In lesions of the cervix and vagina, EFUDIX® management will be performed by the physician. Apply 1 time per week for 8 weeks. It is appropriate after application to place a vaginal buffer (which removed the next day) and zinc oxide in the vulva to protect the area and prevent irritation of healthy skin under the procedure and the next day. In lesions of the vulva and penis, apply a thin layer over the injury previously neat, at night for 4-6 weeks. We recommend applying zinc oxide in the remaining area.
Manifestations and management of overdose or accidental ingestion: At the recommended dose, no changes occur, but if necessary, discontinue treatment.
Presentation: Box with 20 g tube.
Storage recommendations: Keep the tube tightly closed at room temperature to no more than 30 ° C.
LEGENDS OF PROTECTION: Its sale requires a prescription. To be used only under strict medical supervision. Keep out of reach of children.
Name and address of the laboratory: Laboratorios Grossman SA
Registration number: 77246 SSA IV.
IPPA key: SARA-083300414B0022 / RM2009
