COLISTIMETHATE- colistimethate sodium injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

colistimethate (UNII: DL2R53P963) (colistin - UNII:Z67X93HJG1)

Available from:

Xellia Pharmaceuticals ApS

INN (International Name):

colistimethate

Composition:

colistin 150 mg in 2 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Colistimethate for Injection, USP 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, USP 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, USP 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, USP and other antibacterial drugs, Colistimethate for Injection, USP should be used only to treat or

Product summary:

Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to slightly yellow Iyophilized cake. NDC 45932-0023-1: one individual vial. NDC 45932-0023-2: six vials per carton. NDC 45932-0023-3: ten vials per carton. NDC 45932-0023-4: twelve vials per carton. Store between 20° to 25°C (68° to 77°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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

COLISTIMETHATE- COLISTIMETHATE SODIUM INJECTION
XELLIA PHARMACEUTICALS APS
----------
COLISTIMETHATE FOR INJECTION, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of colistimethate
and other antibacterial drugs, colistimethate 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).
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:
Dbu is 2,4-diaminobutanoic acid: R is 5-methylheptyl in colistin A and
5-methylhexyl in colistin B
CLINICAL PHARMACOLOGY
Typical serum and urine levels following a single 150 mg dose of
Colistimethate for Injection, USP 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 to 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