COLISTIMETHATE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

COLISTIN (COLISTIMETHATE SODIUM)

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

J01XB01

INN (International Name):

COLISTIN

Dosage:

150MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

COLISTIN (COLISTIMETHATE SODIUM) 150MG

Administration route:

INTRAMUSCULAR

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

POLYMYXINS

Product summary:

Active ingredient group (AIG) number: 0105857001; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-03-20

Summary of Product characteristics

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
COLISTIMETHATE FOR INJECTION, USP
Sterile Colistimethate sodium
Equivalent to 150 mg colistin base
Parenteral
Powder for Solution
Antibiotic
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite 100
January 27, 2020
Toronto, ON M9W 0C8
Submission Control No.: 231547
Colistimethate for Injection, USP – Prescribing Information
Page 2 of 11
PRESCRIBING INFORMATION
PR
COLISTIMETHATE FOR INJECTION, USP
STERILE COLISTIMETHATE SODIUM
EQUIVALENT TO 150 MG COLISTIN BASE
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Colistimethate is the pentasodium salt of the penta (methanesulfonic
acid) derivative of colistin.
Colistin is a basic polypeptide antibiotic substance produced by the
growth of _Bacillus polymyxa _
_var. colistinus_.
Colistin derivatives appear to alter the permeability of the bacterial
cytoplasmic membrane,
causing leakage of intracellular nucleosides. The drugs are
bactericidal in action.
Intramuscular administration of sodium colistimethate with activity
equivalent to that of 150 mg
of colistin produces peak serum levels of approximately 5 to 7.5
mcg/mL within 2 hours. Peak
serum levels after intravenous administration occur within 10 minutes
and are higher but decline
more rapidly than those achieved after intramuscular administration.
The serum half-life is
approximately 1.5 hours following intravenous and 2.75 to 3 hours
following intramuscular
administration. Blood levels appear to decline more rapidly in
children than in adults.
Hydrolysis of sodium colistimethate is required for antibacterial
activity. Sodium colistimethate
and its metabolites are excreted primarily by the kidneys; urine
levels of the active antibiotic are
considerably higher than serum levels. In 24 hours, approximately 66%
after intramuscular
administration and 75% after intravenous administration is excreted.
INDICATIONS AND CLINICAL USE
Colistimethate for Injection, USP is indicated for the treatment of
acute or chronic inf