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

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

COLISTIN (COLISTIMETHATE SODIUM)

제공처:

STERIMAX INC

ATC 코드:

J01XB01

INN (International Name):

COLISTIN

복용량:

150MG

약제 형태:

POWDER FOR SOLUTION

구성:

COLISTIN (COLISTIMETHATE SODIUM) 150MG

관리 경로:

INTRAMUSCULAR

패키지 단위:

2 ML

처방전 유형:

Prescription

치료 영역:

POLYMYXINS

제품 요약:

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

승인 상태:

MARKETED

승인 날짜:

2002-04-15

제품 특성 요약

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