CEFOXITIN injection powder for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CEFOXITIN SODIUM (UNII: Q68050H03T) (CEFOXITIN - UNII:6OEV9DX57Y)

Tilgjengelig fra:

Apotex Corporation

INN (International Name):

CEFOXITIN SODIUM

Sammensetning:

CEFOXITIN 1 g

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CEFOXITIN- CEFOXITIN INJECTION, POWDER, FOR SOLUTION
APOTEX CORPORATION
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CEFOXITIN FOR INJECTION, USP
ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefoxitin for
injection and other antibacterial drugs, cefoxitin for injection
should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Cefoxitin for injection is a semi-synthetic, broad-spectrum cepha
antibiotic sealed under nitrogen for
intravenous administration. It is derived from cephamycin C, which is
produced by _Streptomyces_
_lactamdurans._ Its chemical name is sodium
(6R,7_S_)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-
thienyl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
carbamate (ester). The molecular
formula is C
H N NaO S , and the structural formula is:
Cefoxitin for injection contains approximately 53.8 mg (2.3
milliequivalents) of sodium per gram of
cefoxitin activity. Solutions of cefoxitin for injection range from
colorless to light amber in color. The
pH of freshly constituted solutions usually ranges from 4.2 to 7. Each
conventional vial contains sterile
cefoxitin sodium, USP equivalent to 1 or 2 g cefoxitin.
CLINICAL PHARMACOLOGY
_CLINICAL PHARMACOLOGY_
Following an intravenous dose of 1 gram, serum concentrations were 110
mcg/mL at 5 minutes,
declining to less than 1 mcg/mL at 4 hours. The half-life after an
intravenous dose is 41 to 59 minutes.
Approximately 85 percent of cefoxitin is excreted unchanged by the
kidneys over a 6 hour period,
resulting in high urinary concentrations. Probenecid slows tubular
excretion and produces higher serum
levels and increases the duration of measurable serum concentrations.
Cefoxitin passes into pleural and joint fluids and is detectable in
antibacterial concentrations in bile.
In a published study of geriatric patients ranging in age from 64 to
88 years with normal renal function
for their age (creatinine clearance ranging from 31.5 to 174.0
mL/min), the half-life for