CEFUROXIME SODIUM injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

cefuroxime sodium (UNII: R8A7M9MY61) (cefuroxime - UNII:O1R9FJ93ED)

Available from:

Sagent Pharmaceuticals

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: - Lower Respiratory Tract Infections , including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes , and Escherichia coli . - Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. - Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes , Escherichia coli, Klebsiella spp., and Enterobacter spp. - Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. - Men

Product summary:

Cefuroxime for Injection, USP is supplied as follows: Cefuroxime for Injection, USP is a dry, white to off-white powder. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFUROXIME SODIUM- CEFUROXIME SODIUM INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
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CEFUROXIME FOR INJECTION, USP
SAGENT
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefuroxime for
Injection and other antibacterial drugs, Cefuroxime for Injection
should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Cefuroxime is a sterile semisynthetic, broad-spectrum, cephalosporin
antibiotic for parenteral administration.
It is the sodium salt of
(6R,7R)-3-[(carbamoyloxy)methyl]-7-[[(Z)-(furan-2-yl)
(methoxyimino)acetyl] amino]-8-
oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, and it has the
following chemical structure:
The empirical formula is C
H
N NaO S, representing a molecular weight of 446.37.
Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq)
of sodium per gram of cefuroxime
activity.
Cefuroxime for Injection, USP in sterile crystalline form is supplied
in vials equivalent to 750 mg or 1.5 g of
cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for
Injection, USP range in color from light yellow
to amber, depending on the concentration and diluent used. The pH of
freshly constituted solutions usually
ranges from 6 to 8.5.
CLINICAL PHARMACOLOGY
After intramuscular (IM) injection of a 750-mg dose of cefuroxime to
normal volunteers, the mean peak serum
concentration was 27 mcg/mL. The peak occurred at approximately 45
minutes (range, 15 to 60 minutes).
Following IV doses of 750 mg and 1.5 g, serum concentrations were
approximately 50 and 100 mcg/mL,
respectively, at 15 minutes. Therapeutic serum concentrations of
approximately 2 mcg/mL or more were
maintained for 5.3 hours and 8 hours or more, respectively. There was
no evidence of accumulation of
cefuroxime in the serum following IV administration of 1.5-g doses
every 8 hours to normal volunteers. The
serum half-life after either IM or IV injections is approximately 80
minutes.
Approximately 89% of