CEFOXITIN- cefoxitin injection, powder, for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Fresenius Kabi USA, LLC

INN (International Name):

CEFOXITIN SODIUM

Sammensætning:

CEFOXITIN 10 g

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 ,

Produkt oversigt:

CEFOXITIN FOR INJECTION, USP is a dry white to off-white powder supplied in pharmacy bulk package bottles containing cefoxitin sodium equivalent to 10 grams of cefoxitin as follows: 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 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. Also available as:

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CEFOXITIN- CEFOXITIN INJECTION, POWDER, FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
CEFOXITIN FOR INJECTION USP
Rx only
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION
RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.
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
semisynthetic, broad-spectrum
cephalosporin antibiotic for parenteral administration. It is derived
from cephalosporin C, which is
produced by _Cephalosporium Acremonium. _It is the sodium (6 _R_, 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, USP is supplied as a dry powder in vials and
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.
Each pharmacy bulk package bottle contains sterile cefoxitin sodium,
USP equivalent to 10 g of
cefoxitin and is intended for intravenous infusion only. A pharmacy
bulk package is a container of a
sterile preparation for parenteral use that contains many single
doses. The contents are intended for use
in a pharmacy admixture service and are restricted to the preparation
of admixtures for intravenous
infusion. FURTHER DILUTION IS REQUIRED BEFORE USE. RECONSTITUTED BULK
SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK
SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.
CLINICAL PHARMACOLOGY:
16
16
3
7
2
CLINICAL PHARMACOLOGY:
Following an intravenous dose of 1 gram, serum concentrat