CEFAZOLIN injection, powder, for solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Sandoz GmbH

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 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.

Dettagli prodotto:

Each Cefazolin for Injection, USP ADD-Vantage® vial contains, cefazolin sodium equivalent to 1 gram of cefazolin. It is supplied in packages of 25 (NDC 43858-100-95). 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].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
SANDOZ GMBH
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CEFAZOLIN FOR INJECTION, USP
ADD-VANTAGE VIAL
FOR INTRAVENOUS ADMINISTRATION
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:
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 ADD-Vantage
vial contains, cefazolin sodium equivalent to 1 gram of cefazolin.
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
mcg/mL at 8 hours for a 1-gram dose.
The serum half-life for cefazolin is approximately 1.8 hours following
IV 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), cefazolin
produced a steady serum level at the third hour of approximately 28
mcg/mL.
Studies in patients hospitalized with infections indicate that
cefazolin produces mean peak serum levels
approximately equivalent to those seen in normal volunteers.
Bile levels in patients without obstructive biliary disease can reach
or exceed serum levels by up to
five times; however, in patients with obstructive biliary disease,
bile levels of cefazolin are
considerably lower than serum levels (<1 mcg/mL).
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In synovial fluid, the level of cefazolin bec