Mafenide adverse reactions

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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]

Adverse Reactions

In the clinical setting of severe burns, it is often difficult to distinguish between an adverse reaction to Mafenide Acetate and burn sequelae. In a clinical study of pediatric patients with acute burns requiring autografts who received Mafenide Acetate,USP for 5% SOLUTION in addition to double antibiotic solution (DAB) wound therapy (neomycin sulfate 40 mg and polymyxin B 200,000 units/ liter), the incidence of rash (4.6%) and itching (2.8%) in the group which received Mafenide Acetate USP For 5% Solution was not different from that experienced with (DAB) dressings alone (5.7% and 1.3%, respectively).

From other clinical settings, a single case of bone marrow depression and a single case of an acute attack of porphyria have been reported following therapy with Mafenide Acetate. Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with mafenide acetate. The following adverse reactions have been reported with topical Mafenide Acetate therapy:[1]


References

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

Adapted from the FDA Package Insert.