MAFENIDE ACETATE powder for solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

RICONPHARMA LLC

INN (Nama Antarabangsa):

MAFENIDE ACETATE

Komposisi:

MAFENIDE ACETATE 50 g

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

MAFENIDE ACETATE- MAFENIDE ACETATE POWDER, FOR SOLUTION
RICONPHARMA LLC
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MAFENIDE ACETATE FOR TOPICAL SOLUTION USP, 5%
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:
C H N O S•C H O M.W.246.29
Mafenide Acetate, USP is a white, crystalline powder which is freely
soluble in water.
Mafenide Acetate 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 si