cefizox- ceftizoxime sodium injection, powder, lyophilized, for solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Fujisawa Healthcare, Inc.

ІПН (Міжнародна Ім'я):

ceftizoxime sodium

Фармацевтична форма:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Склад:

500 mg

Адміністрація маршрут:

INTRAMUSCULAR

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 ampicillin­resistant strains; Staphylococcus aureus (penicillinase­ and nonpenicillinase­producing); Serratia spp.; Enterobacter spp.; Bacteroides spp.; and Streptococcus spp. including S. pneumoniae , but excluding enterococci. Urinary Tract Infections caused by Staphylococcus aureus (penicillinase­ and nonpenicillinase­producing); 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

Огляд продуктів:

Cefizox® (ceftizoxime for injection, USP) NDC 0469­7250­01     Product No. 725001            Equivalent to 500 mg ceftizoxime in 10 mL, single­dose, flip­top vials, individually packaged NDC 0469­7251­01     Product No. 725101             Equivalent to 1 gram ceftizoxime in 20 mL, single­dose, flip­top vials, individually packaged NDC 0469­7252­01     Product No. 725201           Equivalent to 1 gram ceftizoxime in 100 mL, single­dose, Piggyback, flip­top vials, packaged in tens NDC 0469­7253­02     Product No. 725302          Equivalent to 2 grams ceftizoxime in 20 mL, single­dose, flip­top vials, individually packaged NDC 0469­7254­02     Product No. 725402           Equivalent to 2 grams ceftizoxime in 100 mL, single­dose, Piggyback, flip­top vials, packaged in tens Unreconstituted Cefizox should be protected from excessive light, and stored at controlled room temperature (59º­86ºF) in the original package until used. Rx only

Характеристики продукта

CEFIZOX- CEFTIZOXIME SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
FUJISAWA HEALTHCARE, INC.
----------
CEFIZOX
(CEFTIZOXIME FOR INJECTION, USP)
FUJIS AWA
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 INTRAMUSCULAR_
_OR INTRAVENOUS USE_
DES CRIPTION
Cefizox
(ceftizoxime for injection, USP) is a sterile, semisynthetic,
broadspectrum, betalactamase
resistant cephalosporin antibiotic for parenteral (IV, IM)
administration. It is the sodium salt of [6R-
[6a,7β(Z)]]7[[(2,3dihydro2imino4 thiazolyl) (methoxyimino) acetyl]
amino]8oxo5thia1azabicyclo [4.2.0]
oct2ene2carboxylic 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
4 05.38
Ceftizoxime for injection, USP is a white to pale yellow crystalline
powder.
Cefizox is supplied in vials equivalent to 500 mg, 1 gram or 2 grams
of ceftizoxime, and in Piggyback
Vials for IV admixture equivalent to 1 gram or 2 grams of ceftizoxime.
CLINICAL PHARMACOLOGY
The table below demonstrates the serum levels and duration of Cefizox
(ceftizoxime for injection, USP)
following IM administration of 500 mg and 1 gram doses, respectively,
to normal volunteers.
SERUM CONCENTRATIONS AFTER INTRAMUSCULAR ADMINISTRATION SERUM
CONCENTRATION (ΜG/ML)
Dose
½ hr
1 hr
2 hr
4 hr
6 hr
8hr
500 mg
13.3
13.7
9.2
4.8
1.9
0.7
1 gm
36.0
39.0
31.0
15.0
6.0
3.0
Following IV administration of 1, 2, and 3 gram doses of Cefizox to
normal volunteers, the following
serum levels were obtained.
®
®
12
12
5
5
2
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
ND
ND
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
3 grams
221.1
174.0
112.7
83.9
47.4
26.2
4.8
A serum halflife of approximately 1.7 hours was ob