CEFAZOLIN- cefazolin sodium injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFAZOLIN SODIUM (UNII: P380M0454Z) (CEFAZOLIN - UNII:IHS69L0Y4T)

Available from:

Physicians Total Care, Inc.

INN (International Name):

CEFAZOLIN SODIUM

Composition:

CEFAZOLIN SODIUM 500 mg in 10 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefazolin for injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms: RESPIRATORY TRACT INFECTIONS due to Streptococcus pneumoniae, Klebsiella species, Haemophilus influenzae, Staphylococcus 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

Product summary:

Cefazolin for Injection, USP, is supplied in vials containing cefazolin sodium equivalent to 500 mg or 1 gram cefazolin and in infusion bottles containing cefazolin sodium equivalent to 1 gram cefazolin: NDC 54868-4651-0         500mg / 10mL vial, Carton of 25 vials 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°-25°C (68° - 77°F), [see USP Controlled Room Temperature]. Manufactured by: Hikma Farmaceutica (Portugal), Lda. 2705-906 Terrugem SNT – PORTUGAL For: West-Ward Pharmaceutical Corp. 465 Industrial Way West EATONTOWN, NJ 07724 USA Rev. Jan. 2006 PIN001-WES/2

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFAZOLIN - CEFAZOLIN SODIUM INJECTION
PHYSICIANS TOTAL CARE, INC.
----------
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 sterile semi-synthetic
cephalosporin for parenteral administration
(Intramuscular or Intravenous). 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 weight is 476.49.
Cefazolin sodium has the following structural formula:
The sodium content is 48 mg per gram of cefazolin.
Cefazolin for injection, USP is supplied in 500 mg or 1 gram vials for
intramuscular or intravenous use
and in 1 gram infusion bottles for intravenous use.
Each 500 mg or 1 gram vial contains, cefazolin sodium equivalent to
500 mg or 1 gram of cefazolin.
Each 1 gram infusion bottle contains, cefazolin sodium equivalent to 1
gram cefazolin.
CLINICAL PHARMACOLOGY
HUMAN 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) c