CEFOXITIN- 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:

Apotex Corporation

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Many infections caused by aerobic and anaerobic gram-negative bacteria resistant to some cephalosporins respond to cefoxitin. Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics (ampicillin, carbenicillin, penicillin G) respond to treatment with cefoxitin. Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with cefoxitin. Cefoxitin for injection 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

उत्पाद समीक्षा:

Sterile cefoxitin for injection is a dry white to off-white powder supplied in vials containing cefoxitin sodium as follows: Each Pharmacy Bulk Package contains cefoxitin sodium equivalent to 10 grams cefoxitin Also available as vials containing cefoxitin sodium equivalent to 1 gram or 2 grams cefoxitin. Cefoxitin for injection 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

CEFOXITIN- CEFOXITIN INJECTION, POWDER, FOR SOLUTION
APOTEX CORPORATION
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CEFOXITIN FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
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 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,7S)-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 Pharmacy Bulk Package is supplied as a dry powder in vials
containing sterile cefoxitin sodium,
equivalent to 10 g 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 program and are restricted to
the preparation of admixtures for intravenous infusion. FURTHER
DILUTION IS REQUIRED
BEFORE USE.
Each conventional vial contains sterile cefoxitin sodium, USP
eqivalent to 10 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 uncha