COLISTIMETHATE FOR INJECTION U.S.P. POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

COLISTIN (COLISTIMETHATE SODIUM)

から入手可能:

STERIMAX INC

ATCコード:

J01XB01

INN（国際名）:

COLISTIN

投薬量:

150MG

医薬品形態:

POWDER FOR SOLUTION

構図:

COLISTIN (COLISTIMETHATE SODIUM) 150MG

投与経路:

INTRAMUSCULAR

パッケージ内のユニット:

2 ML

処方タイプ:

Prescription

治療領域:

POLYMYXINS

製品概要:

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

認証ステータス:

MARKETED

承認日:

2002-04-15

製品の特徴

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
COLISTIMETHATE FOR INJECTION USP
(colistimethate sodium)
Powder for Solution
(equivalent to 150 mg colistin base)
Antibiotic
SteriMax Inc.
2770 Portland Drive
Oakville, ON L6H 6R4
Date of Revision:
October 19, 2018
Control No.: 213053
PRESCRIBING INFORMATION
PR
COLISTIMETHATE FOR INJECTION, USP
(colistimethate sodium)
Powder for Solution
(equivalent to 150 mg colistin base)
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Colistimethate for Injection USP 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.
INDICATIONS AND CLINICAL USE
Colistimethate for Injection USP is indicated for the treatment of
acute or chronic
infections due to sensitive strains of certain gram-negative bacilli.
Particularly indicated
when the infection is caused by sensitive strains of _P. aeruginosa_.
Th