Mafenide how supplied

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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]

How Supplied

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.[1]


References

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

Adapted from the FDA Package Insert.