CEFAZOLIN 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:

Sandoz Inc

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefazolin for injection is indicated in the treatment of the following infections due to susceptible organisms: Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci . 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 is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin for injection in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci . Skin and Skin Structure Infections: Due to S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci , and other strains of streptococci

Product summary:

Cefazolin for Injection, USP, Pharmacy Bulk Package bottle, contains cefazolin sodium equivalent to 10 grams cefazolin per bottle. NDC 0781-3452-95, 10 grams, Pharmacy Bulk Package bottle, packaged in 10s As with other cephalosporins, Cefazolin for Injection tends to darken depending on storage conditions; within the stated recommendations, however product potency is not adversely affected. Before reconstitution protect from light and store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Clinitest® is a registered trademark of Miles, Inc. Clinistix® is a registered trademark of Bayer Corporation. Revised: September 2020 46276358 Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
SANDOZ INC
----------
CEFAZOLIN FOR INJECTION, USP
RX ONLY
PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefazolin for
injection and other antibacterial drugs, cefazolin for injection
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 (6R,
7R)-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:
MOLECULAR FORMULA: C
H N NAO S
MOLECULAR WEIGHT: 476.5
The sodium content is 48 mg (2.1 mEq) per 1 gram of cefazolin sodium.
Cefazolin for Injection, USP is
a sterile, white to yellowish powder.
Each pharmacy bulk package bottle contains cefazolin sodium equivalent
to 10 grams of cefazolin.
A pharmacy bulk package is a container of a sterile preparation for
parenteral use that contains many
single doses. The contents of this pharmacy bulk package are intended
for use by a pharmacy admixture
service for addition to suitable parenteral fluids in the preparation
of admixtures for intravenous
infusion (see DOSAGE AND ADMINISTRATION, DIRECTIONS FOR PROPER USE OF
PHARMACY BULK
PACKAGE). FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.
CLINICAL PHARMACOLOGY
Studies have shown that following intravenous administration of
cefazolin for injection to normal
volunteers, mean serum concentrations peaked at approximately 185
mcg/mL and were approximately 4
14
13
8
4
3
mcg/mL at 8 hours for a 1-gram dose.
The serum half-life for cefazolin is approximately 1.8 hours following
intravenous administration.
In a study (using normal volunteers) of constant intravenous infusion
with dosages of 3.5 mg/kg for one
hour (approximately 250 mg) and 1.5 mg/kg the next 2 hours
(approximately 100 mg), cef