SULFAMYLON- mafenide acetate cream

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Mylan Institutional Inc.

INN (Nama Internasional):

MAFENIDE ACETATE

Komposisi:

MAFENIDE 85 mg in 1 g

Rute administrasi :

TOPICAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns. SULFAMYLON is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.

Ringkasan produk:

16 oz. Plastic Jar (453.6 g) - NDC 51079-623-83 4 oz. Tube (113.4 g) - NDC 51079-623-82 2 oz. Tube (56.7 g) - NDC 51079-623-81 Avoid exposure to excessive heat (temperature above 104° F or 40° C). For External Use Only. Keep this and all medications out of the reach of children. Rx only Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Revised: 6/2018 030.5 SULFCR:R5

Status otorisasi:

New Drug Application

Karakteristik produk

SULFAMYLON- MAFENIDE ACETATE CREAM
MYLAN INSTITUTIONAL INC.
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DESCRIPTION
SULFAMYLON Cream is a soft, white, nonstaining, water-miscible,
anti-infective cream
for topical administration to burn wounds.
SULFAMYLON Cream spreads easily, and can be washed off readily with
water. It has a
slight acetic odor. Each gram of SULFAMYLON Cream contains mafenide
acetate
equivalent to 85 mg of the base. The cream vehicle consists of cetyl
alcohol, steryl
alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8 stearate,
glycerin, and water,
with methylparaben, propylparaben, sodium metabisulfite, and edetate
disodium as
preservatives.
Chemically, mafenide acetate is α-Amino-ρ-toluenesulfonamide
monoacetate and has the
following structural formula:
CLINICAL PHARMACOLOGY
SULFAMYLON Cream, applied topically produces a marked reduction in the
bacterial
population present in the avascular tissues of second- and
third-degree burns.
Reduction in bacterial growth after application of SULFAMYLON Cream
has also been
reported to permit spontaneous healing of deep partial-thickness
burns, and thus
prevent conversion of burn wounds from partial-thickness to
full-thickness. It should be
noted, however, that delayed eschar separation has occurred in some
cases.
ABSORPTION AND METABOLISM
Applied topically, SULFAMYLON Cream diffuses through devascularized
areas, is
absorbed, and rapidly converted to a metabolite
(ρ-carboxybenzenesulfonamide) which
is cleared through the kidneys. SULFAMYLON is active in the presence
of pus and
serum, and its activity is not altered by changes in the acidity of
the environment.
ANTIBACTERIAL ACTIVITY
SULFAMYLON exerts bacteriostatic action against many gram-negative and
gram-
positive organisms, including _Pseudomonas aeruginosa_ and certain
strains of anaerobes.
INDICATIONS AND USAGE
SULFAMYLON Cream is a topical agent indicated for adjunctive therapy
of patients with
second- and third-degree burns.
CONTRAINDICATIONS
SULFAMYLON is contraindicated in patients who are hypersensitive to
it. It is