CEFAZOLIN- cefazolin sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

cefazolin sodium (UNII: P380M0454Z) (cefazolin - UNII:IHS69L0Y4T)

Available from:

Dispensing Solutions, Inc.

INN (International Name):

cefazolin sodium

Composition:

cefazolin sodium 1 g in 3 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefazolin for Injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections: Due to S. pneumoniae, S. aureus (including beta-lactamase-producing strains) and S. pyogenes . Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available. Urinary Tract Infections: Due to E. coli, P. mirabilis. Skin and Skin Structure Infections: Due to S. aureus (including beta-lactamase-producing strains), S. pyogenes , and other strains of streptococci. Biliary Tract Infections: Due to E. coli , various strains of streptococci, P. mirabilis, and S. aureus . Bone and Joint Infections: Due to S. aureus . Genital Infectio

Product summary:

Cefazolin for Injection, USP, equivalent to 500 mg or 1 g cefazolin per vial, is supplied as follows: As with other cephalosporins, Cefazolin for Injection, USP tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected. Before reconstitution store at 20º to 25ºC (68º to 77ºF). [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

CEFAZOLIN - CEFAZOLIN SODIUM INJECTION, POWDER, FOR SOLUTION
DISPENSING SOLUTIONS, INC.
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CEFAZOLIN FOR INJECTION, USP
FOR IM OR IV USE
SAGENT™
Rx Only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefazolin for
Injection, USP and other antibacterial drugs, Cefazolin for Injection,
USP should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Cefazolin for Injection, USP is a semi-synthetic cephalosporin for
parenteral administration. It is the
sodium salt of
3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl)
acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.
Structural Formula:
Each vial contains 48 mg of sodium/1 gram of cefazolin sodium.
Each vial contains cefazolin sodium equivalent to 500 mg or 1 gram
cefazolin.
CLINICAL PHARMACOLOGY
After intramuscular administration of cefazolin to normal volunteers,
the mean serum concentrations
were 37 mcg/mL at 1 hour and 3 mcg/mL at 8 hours following a 500 mg
dose, and 64 mcg/mL at 1 hour
and 7 mcg/mL at 8 hours following a 1 gram dose.
Studies have shown that following intravenous administration of
cefazolin to normal volunteers, mean
serum concentrations peaked at approximately 185 mcg/mL and were
approximately 4 mcg/mL at 8 hours
for a 1 gram dose.
The serum half-life for cefazolin is approximately 1.8 hours following
IV administration and
approximately 2 hours following IM administration.
In a study (using normal volunteers) of constant intravenous infusion
with dosages of 3.5 mg/kg for 1
hour (approximately 250 mg) and 1.5 mg/kg the next 2 hours
(approximately 100 mg), cefazolin
produced a steady serum level at the third hour of approximately 28
mcg/mL.
Studies in patients hospitalized with infections indicate that
cefazolin produces mean peak serum levels
approximately equivalent to those seen in normal volunteers.
Bile levels in patients without obstructive biliary disease can reach
or exceed serum l