COLISTIMETHATE- colistimethate sodium injection, powder, lyophilized, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

colistimethate sodium (UNII: XW0E5YS77G) (colistimethate - UNII:DL2R53P963)

Tilgjengelig fra:

Sagent Pharmaceuticals

INN (International Name):

colistimethate sodium

Sammensetning:

colistin 150 mg in 2 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Colistimethate for injection is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa . This antibiotic is not indicated for infections due to Proteus or Neisseria . Colistimethate for injection has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Colistimethate for injection may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of colistimethate for injection and other antibacterial drugs, colistimethate for injection should be used only to treat or prevent infections that ar

Produkt oppsummering:

Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as follows: Colistimethate for Injection, USP is a white to slightly yellow lyophilized cake. Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Store reconstituted solution in refrigerator at 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2018 Sagent Pharmaceuticals, Inc. Revised: March 2018 SAGENT Pharmaceuticals®

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

COLISTIMETHATE- COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
COLISTIMETHATE FOR INJECTION, USP
SAGENT
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of colistimethate
for injection and other antibacterial drugs, colistimethate for
injection should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
FOR INTRAMUSCULAR AND INTRAVENOUS USE
DESCRIPTION
Colistimethate for Injection, USP is a sterile parenteral antibiotic
product which, when reconstituted
(see RECONSTITUTION), is suitable for intramuscular or intravenous
administration.
Each vial contains colistimethate sodium or pentasodium
colistinmethanesulfonate (150 mg colistin base
activity). The sodium content is approximately 0.099 mg (0.0043 mEq)
of sodium per milligram of
colistin.
Colistimethate Sodium, USP is pentasodium
[[4-[[3-hydroxy-1-[[1-[[3-(1-hydroxyethyl)-12,15-bis(2-
methylpropyl)-2,5,8,11,14,17,20-heptaoxo-6,9,18-tris[2-(sulfonatomethylamino)ethyl]-
1,4,7,10,13,16,19-heptazacyclotricos-21-yl]amino]-1-oxo-4-(sulfonatomethylamino)butan-2-yl]amino]-
1-oxobutan-2-yl]amino]-3-(6-methyloctanoylamino)-4-oxobutyl]amino]methanesulfonate.
Colistimethate Sodium, USP is a polypeptide antibiotic with an
approximate molecular weight of 1750.
The molecular formula is C
H
N Na O S and the structural formula is represented below:
Colistimethate for Injection, USP is a white to slightly yellow
lyophilized cake. The color of the
reconstituted solution is clear colorless to pale yellow and
essentially free from particles.
CLINICAL PHARMACOLOGY
Typical serum and urine levels following a single 150 mg dose of
colistimethate for injection IM or IV
in normal adult subjects are shown in Figure 1.
FIG URE 1
®
58
105
16
5
28
5
Higher serum levels were obtained at 10 minutes following IV
administration. Serum concentration
declined with a half-life of 2 to 3 hours following either intravenous
or intramuscular administrat