CEFAZOLIN- cefazolin injection, powder, for solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Sandoz Inc

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Cefazolin for Injection, USP is indicated in the treatment of the following 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 strains of str

leaflet_short:

Each vial of Cefazolin for Injection, USP contains cefazolin sodium equivalent to 500 mg cefazolin. NDC 0781-9338-95, 500 mg, carton of 10 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° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
SANDOZ INC
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CEFAZOLIN FOR INJECTION, USP
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 24 mg (1.05 mEq) per 500 mg of cefazolin sodium.
Cefazolin for Injection, USP
is a sterile, white to yellowish powder.
Cefazolin for Injection, USP is supplied in vials equivalent to 500 mg
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 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 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