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:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as: Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°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. Rx only. Manufactured by: Emcure Pharmaceuticals Ltd., Sanand, Ahmedabad – 382110, India. Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 01/2021

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

COLISTIMETHATE SODIUM- COLISTIMETHATE SODIUM INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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COLISTIMETHATE FOR INJECTION, USP
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 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 (seeRECONSTITUTION), is suitable for intramuscular or
intravenous
administration.
Each vial contains colistimethate sodium or pentasodium
colistinmethanesulfonate (150
mg colistin base activity). The sodium content is approximately 0.158
mg (0.0069 mEq)
Sodium per milligram of Colistin. Colistimethate for Injection, USP
contains colistimethate
sodium (equivalent to 150 mg colistin base activity per vial) as a
white to pale yellow
lyophilized cake. The color of the reconstituted solution is clear,
pale yellow.
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 &
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.
FIGURE 1
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 abo