CEFOXITIN injection, powder, for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

WG Critical Care, LLC

DCI (Denominação Comum Internacional):

CEFOXITIN SODIUM

Composição:

CEFOXITIN 1 g

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Treatment 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,

Resumo do produto:

Cefoxitin for Injection, USP is a dry white to off-white powder supplied in conventional vials containing cefoxitin sodium as follows: NDC 44567-245-85 Cefoxitin for Injection, USP contains cefoxitin sodium equivalent to 1 gram cefoxitin (carton of 25 vials). NDC 44567-246-85 Cefoxitin for Injection, USP contains cefoxitin sodium equivalent to 2 grams cefoxitin (carton of 25 vials). The container closure is not made with natural rubber latex. Special storage instructions Cefoxitin for Injection, USP in the dry state should be stored between 2º to 25ºC (36º to 77ºF). Avoid exposure to temperatures above 50ºC. The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CEFOXITIN- CEFOXITIN INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
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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 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)