CEFAZOLIN - cefazolin injection, powder, for solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Cefazolin Sodium (UNII: P380M0454Z) (Cefazolin - UNII:IHS69L0Y4T)

Boleh didapati daripada:

General Injectables & Vaccines, Inc

INN (Nama Antarabangsa):

Cefazolin Sodium

Komposisi:

Cefazolin Sodium 500 mg in 500 mg

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Cefazolin for Injection 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 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 penicilin-resistant), group A beta-hemolytic streptococci, and other strains of streptococc

Ringkasan produk:

Each vial contains cefazolin sodium equivalent to 500 mg or 1 gram cefazolin. NDC 0781-3450-95, 500 mg, packaged in 10s NDC 0781-3451-96, 1 gram, package in 25s As with other cephalosporins, Cefazolin for Injection 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].    REFERENCE    1. National Committee for Clinical Laboratory Standards (NCCLS). January 2003. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Eighth Edition. NCCLS Document M2-A8 and Disk Diffusion Supplemental Tables M100-S13. NCCLS, Wayne, PA, USA. January 2000.    2. National Committee for Clinical Laboratory Standards (NCCLS). January 2003. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard-Sixth Edition. NCCLS Document M7-A6 and MIC Testing Supplemental Tables, M100-S13. NCCLS, Wayne, PA, USA. January 2000.   Clinitest® is a registered trademark of Miles, Inc. Clinistix® is a registered trademark of Bayer Corporation. 06-2009 Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540   

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CEFAZOLIN - CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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CEFAZOLIN SODIUM INJECTION USP 500MG
DESCRIPTION
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 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.
Structural Formula:
The sodium content is 24 mg (1.05 mEq) per 500 mg of cefazolin sodium
and 48 mg (2.1 mEq) per 1
gram of cefazolin sodium. Cefazolin for Injection is a sterile, white
to yellowish powder.
Cefazolin for Injection is supplied in vials equivalent to 500 mg of
cefazolin or to 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 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 l