COLY-MYCIN M POWDER FOR SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

COLISTIN (COLISTIMETHATE SODIUM)

MAH:

SEARCHLIGHT PHARMA INC

ATC_code:

J01XB01

INN:

COLISTIN

dosage:

150MG

pharmaceutical_form:

POWDER FOR SOLUTION

composition:

COLISTIN (COLISTIMETHATE SODIUM) 150MG

administration_route:

INTRAMUSCULAR

units_in_package:

1VIAL

prescription_type:

Prescription

therapeutic_area:

POLYMYXINS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2022-10-07

SPC

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
COLY-MYCIN M
COLISTIMETHATE FOR INJECTION U.S.P.
STERILE COLISTIMETHATE SODIUM
EQUIVALENT TO 150 MG COLISTIN BASE
PARENTERAL
ANTIBIOTIC
Searchlight Pharma Inc.
1600 Notre-Dame West, suite 312
Montreal, QC
H3J 1M1
Date of Preparation: OCT 7, 2022
Submission Control No: 267423
2
PRESCRIBING INFORMATION
PR
COLY-MYCIN M
COLISTIMETHATE FOR INJECTION U.S.P.
STERILE COLISTIMETHATE SODIUM
EQUIVALENT TO 150 MG COLISTIN BASE
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
COLY-MYCIN M (Colistimethate for Injection U.S.P.) 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.
IM administration of sodium colistimethate with activity equivalent to
that of 150 mg of colistin
produces peak serum levels of approximately 5 to 7.5 µg/mL within 2
hours. Peak serum levels
after IV administration occur within 10 minutes and are higher but
decline more rapidly than
those achieved after IM administration. The serum half-life is
approximately 1.5 hours following
IV and 2.75 to 3 hours following IM 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 IM administration
and 75% after IV administration is excreted.
3
INDICATIONS AND CLINICAL USE
COLY-MYCIN M (Colistimethate for Injection U.S.P.) is indicated for
the treatment of acute or
chronic infections due to sensitive strains of certain gram-negative
bacilli. Particularly in