CEFOXITIN- cefoxitin sodium powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

CEFOXITIN SODIUM

Composition:

CEFOXITIN 1 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CEFOXITIN FOR INJECTION, USP is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections , including pneumonia and lung abscess, caused by Streptococcus pneumoniae , other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species. (2) Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgaris and Providencia species (including P. rettgeri ). (3) Intra-abdominal infections , including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis , and Clostridium species. (4) Gynecological infections , including endometritis, pelvi

Product summary:

CEFOXITIN FOR INJECTION, USP is a dry white to off-white powder supplied in conventional vials containing cefoxitin sodium as follows:          The container closure is not made with natural rubber latex.   CEFOXITIN FOR INJECTION, USP in the dry state should be stored between 2° to 25°C (36° to 77°F). Avoid exposure to temperatures above 50°C. The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFOXITIN - CEFOXITIN SODIUM POWDER, FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
451410C/ Revised: May 2021
CEFOXITIN
_for Injection, USP_ RX 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, USP contains cefoxitin sodium a
semi-synthetic, broad-
spectrum cephalosporin antibiotic for parenteral administration. It is
derived from
cephalosporin C, which is produced by _Cephalosporium Acremonium. _It
is the sodium
salt of
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, USP contains approximately 53.8 mg (2.3
milliequivalents) of
sodium per gram of cefoxitin activity. Solutions of CEFOXITIN FOR
INJECTION, USP
range from colorless to light amber in color. The pH of freshly
constituted solutions
usually ranges from 4.2 to 7.0.
Each conventional vial contains sterile cefoxitin sodium, USP
equivalent to 1 or 2 grams
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
16
16
3
7 2
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 (creatini