COLISTIMETHATE sodium injection powder lyophilized for solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

COLISTIMETHATE SODIUM (UNII: XW0E5YS77G) (COLISTIMETHATE - UNII:DL2R53P963)

Dostopno od:

Paddock Laboratories, LLC

INN (mednarodno ime):

COLISTIMETHATE SODIUM

Sestava:

COLISTIN 150 mg in 2 mL

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

COLISTIMETHATE- COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
PADDOCK LABORATORIES, LLC
----------
COLISTIMETHATE FOR INJECTION, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of colistimethate
for injection and other antibacterial drugs, colistimethate for
injection should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
FOR INTRAMUSCULAR AND INTRAVENOUS USE
DESCRIPTION
Colistimethate for Injection, USP is a sterile parenteral antibiotic
product which, when reconstituted
(see RECONSTITUTION), is suitable for intramuscular or intravenous
administration.
Each vial contains colistimethate sodium or pentasodium
colistinmethanesulfonate (150 mg colistin base
activity).
Colistimethate sodium is a polypeptide antibiotic with an approximate
molecular weight of 1750. The
molecular formula is C
H
N Na O S and the structural formula is represented below:
Dbu is 2,4-diaminobutanoic acid; R is 5-methylheptyl in colistin A and
5-methylhexyl in colistin B
CLINICAL PHARMACOLOGY
Typical serum and urine levels following a single 150 mg dose of
colistimethate for injection IM or IV
in normal adult subjects are shown in Figure 1.
58
105
16
5
28
5
Higher serum levels were obtained at 10 minutes following IV
administration. Serum concentration
declined with a half-life of 2-3 hours following either intravenous or
intramuscular administration in
adults and in the pediatric population, including premature infants.
Average urine levels ranged from about 270 mcg/mL at 2 hours to about
15 mcg/mL at 8 hours after
intravenous administration and from 200 to about 25 mcg/mL during a
similar period following
intramuscular administration.
MICROBIOLOGY:
Colistimethate sodium is a surface active agent which penetrates into
and disrupts the bacterial cell
membrane. It has been shown to have bactericidal activity against most
strains of the following
microorganisms, both _in vitro _and in clinical infections as
described in the I