Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
MAFENIDE ACETATE (UNII: RQ6LP6Z0WY) (MAFENIDE - UNII:58447S8P4L)
Par Pharmaceutical, Inc.
MAFENIDE ACETATE
MAFENIDE 50 g
TOPICAL
PRESCRIPTION DRUG
Mafenide Acetate,USP For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds. Mafenide Acetate ,USP For 5% Topical Solution is contraindicated in patients who are hypersensitive to mafenide acetate. It is not known whether there is cross sensitivity to other sulfonamides.
Mafenide Acetate , USP for 5% Topical Solution is available in packets containing 50 g of sterile Mafenide Acetate to be prepared using 1000 mL Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. (See DOSAGE AND ADMINISTRATION: MAFENIDE ACETATE USP for 5% Topical Solution: Directions for Preparation of the Solution.) The packets are supplied as follows: Carton of five 50 g packets (NDC #49884-902-78). Recommended Storage Packets - Store PACKETS in a dry place at room temperature 15° to 30°C (59° to 86°F). Prepared Solution - Store SOLUTION at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] The solution may be held for up to 28 days if stored in unopened containers. ONCE A CONTAINER IS OPENED, ANY UNUSED SOLUTION MUST BE DISCARDED WITHIN 48 HOURS. Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103. Made in India Mfg. Lic. No.: TN00002121 SE7500/02 OS902-01-74-03 Rev: 06/16
Abbreviated New Drug Application
MAFENIDE ACETATE- MAFENIDE ACETATE POWDER, FOR SOLUTION PAR PHARMACEUTICAL, INC. ---------- MAFENIDE ACETATE ,USP FOR 5% TOPICAL SOLUTION STERILE RX ONLY DESCRIPTION Mafenide Acetate, USP is a synthetic antimicrobial agent designated chemically as α- amino-_p_-toluenesulfonamide monoacetate. It has the following structural formula: Mafenide Acetate, USP is a white, crystalline powder which is freely soluble in water. Mafenide Acetate,USP For 5% Topical Solution is provided in packets containing 50 g of sterile Mafenide Acetate to be reconstituted in 1000 mL of Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. After mixing, the solution contains 5% w/v of mafenide acetate. The solution is an antimicrobial preparation suitable for topical administration. THE SOLUTION IS NOT FOR INJECTION. The reconstituted solution may be held up to 28 days after preparation if stored in unopened containers. ONCE A CONTAINER IS OPENED, ANY UNUSED PORTION SHOULD BE DISCARDED AFTER 48 HOURS. Store the reconstituted solution at 20° to 25°C (68° to 77°F). Limited storage periods at 15° to 30°C (59° to 86°F) are acceptable. CLINICAL PHARMACOLOGY MECHANISM OF ACTION: The mechanism of action of Mafenide is not known, but is different from that of the sulfonamides. Mafenide is not antagonized by pABA, serum, pus or tissue exudates, and there is no correlation between bacterial sensitivities to mafenide and to the sulfonamides. Its activity is not altered by changes in the acidity of the environment. The osmolality of the 5% topical solution is approximately 340 mOsm/kg. ABSORPTION AND METABOLISM: Applied topically, Mafenide Acetate diffuses through devascularized areas. Approximately 80% of a Mafenide Acetate dose is delivered to burned tissue over four hours following topical application of the 5% solution. Following application of Mafenide Acetate cream and solution, peak Mafenide concentrations in human burned skin tissue occur at two and four hours, respectively. Peak tissue concentrations are similar Læs hele dokumentet