SULFAMYLON- mafenide acetate cream

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Rising Pharma Holdings, Inc.

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

16 oz. Plastic Jar (453.6 g) - NDC 16571-723-48 4 oz. Tube (113.4 g) - NDC 16571-723-12 2 oz. Tube (56.7 g) - NDC 16571-723-60 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 Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Revised: 08/2020 PIR72348-00

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

SULFAMYLON - MAFENIDE ACETATE CREAM
RISING PHARMA HOLDINGS, 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. I