Mafenide description

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Mafenide
MAFENIDE ACETATE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Mafenide Acetate, USP is a synthetic antimicrobial agent designated chemically as α-amino-p-toluenesulfonamide monoacetate. It has the following structural formula:

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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. [1]


References

  1. "MAFENIDE ACETATE POWDER, FOR SOLUTION [PAR PHARMACEUTICAL COMPANIES, INC.]".

Adapted from the FDA Package Insert.