CEFAZOLIN injection, powder, for solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

WG Critical Care, LLC

Начин на приложение:

INTRAMUSCULAR

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

Cefazolin for Injection, USP containing cefazolin sodium equivalent to 1 gram cefazolin per vial is supplied as follows: NDC 44567-120-25 1 gram single-dose vial (carton of 25) As with other cephalosporins, cefazolin 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]. CLINITEST is a registered trademark of Miles, Inc. CLINISTIX is a registered trademark of Bayer Corporation. Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Made in Italy Revised: July 2020

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
----------
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 1 gram of cefazolin.
The sodium content is 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
14
13
8
4 3
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 and approximately 2 hours following I.M.
administration.
In a study (using normal volunteers) of constant intravenous infusion
with dosages of
3.5 mg/kg for 1 hour (appr