SULFAMYLON- 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:

Mylan Institutional Inc.

INN (International Name):

MAFENIDE ACETATE

Composition:

MAFENIDE ACETATE 50 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SULFAMYLON® 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. SULFAMYLON® 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:

SULFAMYLON® (mafenide acetate, USP) for 5% Topical Solution is available in packets (NDC 51079-624-84) 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: SULFAMYLON® for 5% Topical Solution: Directions for Preparation of the Solution.) The packets are supplied as follows: Carton of five 50 g packets NDC 51079-624-85 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. Keep this and all medications out of the reach of children. Mylan Institutional Inc. Rockford, IL 61103 U.S.A. 095.7 Revised: 6/2018

Authorization status:

New Drug Application

Summary of Product characteristics

SULFAMYLON- MAFENIDE ACETATE POWDER, FOR SOLUTION
MYLAN INSTITUTIONAL INC.
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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.
SULFAMYLON® 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
following
administration of the solution or cream. Once absorbed, mafenide is