Colomycin Injection 1 million International Units POWDER FOR SOLUTION FOR INJECTION INFUSION OR INHALATION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

COLISTIMETHATE SODIUM

Available from:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (International Name):

COLISTIMETHATE SODIUM

Units in package:

1MIUx10 Vials

Manufactured by:

Xellia Pharmaceuticals ApS

Summary of Product characteristics

COLOMYCIN INJECTION- PRESCRIBING INFORMATION
PRODUCT NAME
Colomycin Injection 1 million International Units. Powder for solution
for injection, infusion or inhalation.
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each vial contains 1 million International Units colistimethate
sodium.
PRODUCT DESCRIPTION
Colomycin is a sterile white powder for solution for injection,
infusion or inhalation, in a 10ml colorless glass vial with a
red ‘flip-off’ cap.
PHARMACODYNAMICS
_Mode of Action_
Colistimethate sodium is a cyclic polypeptide antibiotic derived from
_Bacillus polymyxa _var. _colistinus_ and belongs to
the polymyxin group. The polymyxin antibiotics are cationic agents
that work by damaging the cell membrane. The
resulting physiological affects are lethal to the bacterium.
Polymyxins are selective for Gram-negative bacteria that
have a hydrophobic outer membrane.
_Resistance_
Resistant bacteria are characterised by modification of the phosphate
groups of lipopolysaccharide that become
substituted with ethanolamine or aminoarabinose. Naturally resistant
Gram-negative bacteria, such as Proteus _mirabilis_
and _Burkholderia cepacia_, show complete substitution of their lipid
phosphate by ethanolamine or aminoarabinose.
_Cross resistance_
Cross resistance between colistimethate sodium and polymyxin B would
be expected. Since the mechanism of
action of the polymyxins is different from that of other antibiotics,
resistance to colistin and polymyxin by the above
mechanism alone would not be expected to result in resistance to other
drug classes.
_Breakpoints_
The suggested general MIC breakpoint to identify bacteria susceptible
to colistimethate sodium is ≤4mg/l.
Bacteria for which the MIC of colistimethate sodium is ≥8mg/l should
be considered resistant.
_Susceptibility_
The prevalence of acquired resistance may vary geographically and with
time for selected species and local
information on resistance is desirable, particularly when treating
severe infections. As necessary, expert advice should
be sought when the local