COLISTIMETHATE 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:

XGen Pharmaceuticals DJB, Inc.

INN (International Name):

COLISTIMETHATE SODIUM

Sammensetning:

COLISTIN 150 mg in 2 mL

Administreringsrute:

INTRAMUSCULAR

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 In

Produkt oppsummering:

Rx only Colistimethate for Injection USP is supplied in vials (NDC 39822-0615-1) containing colistimethate sodium (equivalent to 150 mg colistin base per vial) as a white to slightly yellow lyophilized cake and is available as twelve vial per carton (NDC 39822-0615-2). Store between 20˚ to 25˚C (68˚ to 77˚F). Excursions permitted to 15° to 30°C (59° to 86°F). (See USP controlled room temperature). Store reconstituted solution in refrigerator 2˚ to 8˚C (36˚ to 46˚F) or between 20˚ to 25˚C (68˚ to 77˚F) and use within 7 days. Manufactured for: X-GEN Pharmaceuticals, Inc. Big Flats, NY 14814 Manufactured in the USA COLI-PI12-01 Revised September 2017

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

COLISTIMETHATE- COLISTIMETHATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
XGEN PHARMACEUTICALS DJB, INC.
----------
COLISTIMETHATE FOR INJECTION, USP
RX ONLY
FOR INTRAMUSCULAR AND INTRAVENOUS USE
FOR INTRAMUSCULAR AND INTRAVENOUS USE
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.
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).
Colistimethate sodium is a polypeptide antibiotic with an approximate
molecular weight of
1750. The empirical formula is C
H
N
Na
O
S
and the structural formula is
represented below:
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.
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 2-3 hours following either
intravenous or
intramuscular administration in adults and in the pediatric
population, including
premature infants.
Average urine levels ranged from about 270 mcg/mL at 2 hours to about
15 mcg/mL at
8 hours after intravenous administration and from 200 to about 25
mcg/mL during a
similar period following intramuscular administration.
_MICROBIOLOGY_
Colistimethate sodium is a surface active agent which penetrates into
and disrupts the
bacterial cell membrane. It has been shown to have bactericidal
activity against most
strains of the following microorganisms, both _in vitro_ and in
clinical infections as
described in the INDICATIONS AND USAGE section:
AEROBIC GRAM-NEGATIVE MIC