cefizox- ceftizoxime injection, powder, lyophilized, for solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

ceftizoxime sodium (UNII: 26337D5X88) (ceftizoxime - UNII:C43C467DPE)

Dostupné z:

Fujisawa Healthcare, Inc.

INN (Medzinárodný Name):

ceftizoxime

Forma lieku:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Zloženie:

1 g

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Cefizox (ceftizoxime for injection, USP) is indicated in the treatment of infections due to susceptible strains of the microorganisms listed below. Lower Respiratory Tract Infections caused by Klebsiella spp.; Proteus mirabilis ; Escherichia coli; Haemophilus influenzae including ampicillin‐resistant strains; Staphylococcus aureus (penicillinase­ and nonpenicillinase‐producing); Serratia spp.; Enterobacter spp.; Bacteroides spp.; and Streptococcus spp. including S. pneumoniae , but excluding enterococci. Urinary Tract Infections caused by Staphylococcus aureus (penicillinase‐ and nonpenicillinase‐producing); Escherichia coli ; Pseudomonas spp. including P. aeruginosa ; Proteus mirabilis ; P. vulgaris ; Providencia rettgeri (formerly Proteus rettgeri ) and Morganella morganii (formerly Proteus morganii ); Klebsiella spp.; Serratia spp. including S. marcescens ; and Enterobacter spp. Gonorrhea including uncomplicated cervical and urethral gonorrhea caused by Neisseria gonorrhoeae . Pelvic Inflamma

Prehľad produktov:

Cefizox® (ceftizoxime for injection, USP) in ADD-Vantage® Vials equivalent to 1 gram ceftizoxime, packaged in tens equivalent to 2 grams ceftizoxime, packaged in tens Unreconstituted Cefizox should be protected from excessive light, and stored at controlled room temperature 15°-30°C (59°-86°F) in the original package until used. ADD-Vantage® is registered trademark of Abbott Laboratories. U.S. Patent 4,427,674 Product of Japan REFERENCES Manufactured for Fujisawa Healthcare, Inc. Deerfield, IL 60015-2548 by GlaxoSmithKline, Philadelphia, PA 19101

Súhrn charakteristických

CEFIZOX- CEFTIZOXIME INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
FUJISAWA HEALTHCARE, INC.
----------
CEFIZOX®
(CEFTIZOXIME FOR INJECTION, USP)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefizox and
other antibacterial drugs, Cefizox should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
FOR INTRAVENOUS INFUSION
DES CRIPTION
Cefizox
(ceftizoxime for injection, USP) is a sterile, semisynthetic, broad
spectrum, beta lactamase
resistant cephalosporin antibiotic for parenteral (IV, IM)
administration. It is the sodium salt of [6R-
[6a,7β(Z)]] 7 [[(2,3 dihydro 2 imino 4 thiazolyl) (methoxyimino)
acetyl] amino] 8 oxo 5 thia 1
azabicyclo [4.2.0] oct 2 ene 2 carboxylic acid. Its sodium content is
approximately 60 mg (2.6 mEq)
per gram of ceftizoxime activity.
It has the following structural formula:
C H N NAO S
405.38
Ceftizoxime for injection, USP is a white to pale yellow crystalline
powder.
Cefizox is supplied in ADD-vantage
vials as ceftizoxime sodium equivalent to 1 gram or 2 grams
ceftizoxime.
CLINICAL PHARMACOLOGY
Following IV administration of 1, 2, and 3 gram doses of Cefizox to
normal volunteers, the following
serum levels were obtained.
SERUM CONCENTRATIONS AFTER INTRAVENOUS ADMINISTRATION
Serum Concentration (µg/mL)
Dose
5 min
10 min
30 min
1 hr
2 hr
4 hr
8 hr
1 gram
60.5
38.9
21.5
8.4
1.4
2 grams
131.8
110.9
77.5
53.6
33.1
12.1
2.0
®
13
12
5
5
2
®
*
*
*
3 grams
221.1
174.0
112.7
83.9
47.4
26.2
4.8
A serum half life of approximately 1.7 hours was observed after IV or
IM administration.
Cefizox is 30% protein bound.
Cefizox is not metabolized, and is excreted virtually unchanged by the
kidneys in 24 hours. This
provides a high urinary concentration. Concentrations greater than
6000 μg/mL have been achieved in
the urine by 2 hours after a 1 gram dose of Cefizox intravenously.
Probenecid slows tubular secretion
and produces even higher serum levels, increasing the duration of
measurable serum concentrat