COLISTIMETHATE- colistimethate sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Colistimethate Sodium (UNII: XW0E5YS77G) (Colistimethate - UNII:DL2R53P963)

Available from:

Xellia Pharmaceuticals USA LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Colistimethate for Injection, USP is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa . This antibiotic is not indicated for infections due to Proteus or Neisseria . Colistimethate for Injection, USP has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Colistimethate for Injection, USP may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Colistimethate for Injection, USP and other antibacterial drugs, Colistimethate for Injection, USP should be used only to treat or p

Product summary:

Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to slightly yellow Iyophilized cake. NDC-70594-023-09: one individual vial. Store between 20° to 25°C (68° to 77°F). (See USP controlled room temperature). Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F), and use within 7 days.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

COLISTIMETHATE- COLISTIMETHATE SODIUM INJECTION, POWDER, FOR SOLUTION
XELLIA PHARMACEUTICALS USA LLC
----------
COLISTIMETHATE FOR INJECTION, USP
2530-A
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
colistimethate and other antibacterial drugs, colistimethate 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 empirical 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, USP IM or IV in normal adult subjects are shown in Figure
1.
58
105
16
5
28 5
FIGURE 1: TYPICAL SERUM AND URINE LEVELS FOLLOWING A SINGLE 150 MG
DOSE OF
COLISTIMETHATE FOR INJECTION, USP IM OR IV IN NORMAL ADULT SUBJECTS
Higher serum levels were obtained at 10 minutes following IV
administration. Serum
concentration declined with a half-life of 2 to 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 bactericida