MAFENIDE ACETATE powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MAFENIDE ACETATE (UNII: RQ6LP6Z0WY) (MAFENIDE - UNII:58447S8P4L)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

MAFENIDE ACETATE

Composition:

MAFENIDE 50 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MAFENIDE ACETATE- MAFENIDE ACETATE POWDER, FOR SOLUTION
PAR PHARMACEUTICAL, INC.
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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