CEFAZOLIN injection, powder, for solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

A-S Medication Solutions

Spôsob podávania:

INTRAMUSCULAR

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Cefazolin for Injection, USP is indicated for the treatment of the following serious infections when 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 strain

Prehľad produktov:

Product: 50090-2238 NDC: 50090-2238-0 1 INJECTION, POWDER, FOR SOLUTION in a VIAL

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
A-S MEDICATION SOLUTIONS
----------
CEFAZOLIN FOR INJECTION, USP
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:
C
H N NaO S M.W. 476.5
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 I.V. administration
14
13
8
4
3
and approximately 2 hours following I.M. administration.
In a study (using normal volunteers) of constant in