CEFAZOLIN- cefazolin sodium injection, powder, for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Sagent Pharmaceuticals

INN (Mezinárodní Name):

Cefazolin Sodium

Složení:

cefazolin 500 mg in 2.2 mL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Cefazolin for Injection, USP is indicated for 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 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

Přehled produktů:

Cefazolin for Injection, USP, containing cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin, is supplied as follows: Cefazolin for Injection, USP is also available in a 10 gram Pharmacy Bulk Package. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams of cefazolin and is supplied 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. Storage Conditions Before reconstitution, store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Brands listed are the trademarks of their respective owners. PREMIER ProRx® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Italy ©2020 Sagent Pharmaceuticals, Inc. PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Revised: July 2020

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CEFAZOLIN- CEFAZOLIN SODIUM INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
CEFAZOLIN FOR INJECTION, USP
PREMIERProRx
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 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 pH of the reconstituted solution is between 4 and 6.
Cefazolin for Injection, USP is a sterile white to cream powder
supplied in vials. Each vial
contains, cefazolin sodium equivalent to 500 mg or 1 gram of
cefazolin.
The sodium content is approximately 24 mg (1 mEq)/500 mg of cefazolin
sodium or
approximately 48 mg (2.1 mEq)/1 gram of cefazolin sodium.
The color of Cefazolin for Injection, USP solutions may range from
pale yellow to yellow
without a change in potency.
Cefazolin for Injection, USP is to be administered by intramuscular or
intravenous
routes.
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 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 infusi