Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
MAFENIDE ACETATE (UNII: RQ6LP6Z0WY) (MAFENIDE - UNII:58447S8P4L)
Rising Pharma Holdings, Inc.
TOPICAL
PRESCRIPTION DRUG
SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns. SULFAMYLON is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.
16 oz. Plastic Jar (453.6 g) - NDC 16571-723-48 4 oz. Tube (113.4 g) - NDC 16571-723-12 2 oz. Tube (56.7 g) - NDC 16571-723-60 Avoid exposure to excessive heat (temperature above 104° F or 40° C). For External Use Only. Keep this and all medications out of the reach of children. Rx only Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Revised: 08/2020 PIR72348-00
New Drug Application
SULFAMYLON - MAFENIDE ACETATE CREAM RISING PHARMA HOLDINGS, INC. ---------- DESCRIPTION SULFAMYLON Cream is a soft, white, nonstaining, water-miscible, anti-infective cream for topical administration to burn wounds. SULFAMYLON Cream spreads easily, and can be washed off readily with water. It has a slight acetic odor. Each gram of SULFAMYLON Cream contains mafenide acetate equivalent to 85 mg of the base. The cream vehicle consists of cetyl alcohol, steryl alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8 stearate, glycerin, and water, with methylparaben, propylparaben, sodium metabisulfite, and edetate disodium as preservatives. Chemically, mafenide acetate is α-Amino-ρ-toluenesulfonamide monoacetate and has the following structural formula: CLINICAL PHARMACOLOGY SULFAMYLON Cream, applied topically produces a marked reduction in the bacterial population present in the avascular tissues of second- and third-degree burns. Reduction in bacterial growth after application of SULFAMYLON Cream has also been reported to permit spontaneous healing of deep partial-thickness burns, and thus prevent conversion of burn wounds from partial-thickness to full-thickness. It should be noted, however, that delayed eschar separation has occurred in some cases. ABSORPTION AND METABOLISM Applied topically, SULFAMYLON Cream diffuses through devascularized areas, is absorbed, and rapidly converted to a metabolite (ρ-carboxybenzenesulfonamide) which is cleared through the kidneys. SULFAMYLON is active in the presence of pus and serum, and its activity is not altered by changes in the acidity of the environment. ANTIBACTERIAL ACTIVITY SULFAMYLON exerts bacteriostatic action against many gram-negative and gram- positive organisms, including _Pseudomonas aeruginosa_ and certain strains of anaerobes. INDICATIONS AND USAGE SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns. CONTRAINDICATIONS SULFAMYLON is contraindicated in patients who are hypersensitive to it. I Đọc toàn bộ tài liệu