CEFOXITIN injection, powder, for solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

WG Critical Care, LLC

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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,

उत्पाद समीक्षा:

Cefoxitin for Injection, USP is a dry white to off-white powder supplied in Pharmacy Bulk Package Bottles containing cefoxitin sodium equivalent to10 grams of cefoxitin as follows: NDC 44567-247-10 Cefoxitin for Injection, USP contains cefoxitin sodium equivalent to 10 grams of cefoxitin in a 100 mL bottle (cartons of 10 bottles). 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. Also available as vials of: NDC 44567-245-25 Cefoxitin for Injection, USP contains cefoxitin sodium equivalent to 1 gram cefoxitin (carton of 25 vials). NDC 44567-246-25 Cefoxitin for Injection, USP contains cefoxitin sodium equivalent to 2 grams cefoxitin (carton of 25 vials).

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

CEFOXITIN- CEFOXITIN INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
----------
CEFOXITIN FOR INJECTION, USP
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, USP and other antibacterial drugs, Cefoxitin
for Injection, USP
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_. Its chemical name is
sodium
(6R,7S)-3-(hydroxymethyl)-7methoxy-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
_Clinical Pharmacology_
16
16
3
7 2
Following an intravenous dose of 1 gram, serum concentratio