CEFAZOLIN- 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:

Apotex Corporation

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 , 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, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP 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 s

Product summary:

Cefazolin for injection, USP, is supplied in 10 grams Pharmacy Bulk Package. 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. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Before reconstitution PROTECT FROM LIGHT.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
APOTEX CORPORATION
----------
CEFAZOLIN FOR INJECTION, USP
PHARMACY BULK PACKAGE-
NOT FOR DIRECT INFUSION
ONLY
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 (6_R_,7_R_)-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.
The molecular formula is
C
H N NaO S and molecular weight is 476.49.
Structural Formula:
Each vial contains 48 mg (2 mEq) of sodium/1 gram of cefazolin sodium.
Cefazolin for injection, USP is
white to off-white crystalline powder.
Cefazolin for Injection, USP is supplied in 10 grams Pharmacy Bulk
Packages. Each Pharmacy Bulk
Package contains cefazolin sodium equivalent to 10 grams of cefazolin.
After reconstitution with either
45 mL or 96 mL of diluent the concentration is 1 gram cefazolin per 5
mL or 1 gram cefazolin per 10
mL, respectively. The pH of the reconstituted solution is between 4.0
and 6.0.
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
After intramuscular administration of Cefazolin for Injection 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
14
13
8
4
3
concentrations were 37