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:

Hikma Pharmaceuticals USA Inc.

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 st

Product summary:

Cefazolin for Injection, USP is supplied in vials containing cefazolin sodium equivalent to 1 gram cefazolin. Also available as Pharmacy Bulk Package, 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 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
HIKMA PHARMACEUTICALS USA INC.
----------
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.
14
13
8
4 3
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 me