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:

Cardinal Health

INN (International Name):

CEFAZOLIN SODIUM

Composition:

CEFAZOLIN 330 mg in 1 mL

Administration route:

INTRAMUSCULAR

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 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 stre

Product summary:

Cefazolin for Injection, USP is supplied in vials containing cefazolin sodium equivalent to 500 mg or 1 gram cefazolin.  Cefazolin for Injection, USP  Vial Size Packaged   NDC No.   1 gram 10 mL Overbagged with 5 vials per bag 55154-7463-5 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 protect from light and store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
CARDINAL HEALTH
----------
CEFAZOLIN FOR INJECTION, USP
RX 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 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 of sodium/1 gram of cefazolin sodium.
Cefazolin for Injection, USP is white to off-white crystalline powder,
supplied in vials equivalent to
500 mg or 1 gram of cefazolin.
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
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 for Injection 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 for Injection 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 for
Injection produced a steady serum level at the third hour of
approximately 28 mcg/mL.
Studies in patients hospitalized with infections indicate that
Cefazolin for Injection produces mean peak
serum levels approxi