Rx Item-Coly-Mycin M colistimethate 150Mg Vial 1 By JHP Pharma

Clinical Information
Gen. Code and Des.
9357 colistin (colistimethate Na) INJECTION VIAL 150 MG
GCN and Des.
41350 colistin (colistimethate Na) INJECTION VIAL 150 MG
Strength
150MG
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
8122828 POLYMYXIN ANTIBIOTICS
Active Ingredients
2805 colistimethate sodium 8068288
Inactive Ingredients



COLY-MYCIN M- colistimethate sodium injection
JHP Pharmaceuticals LLC

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M 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

Coly-Mycin� M Parenteral (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 C58 H105 N16 Na5 O28 S5 and the structural formula is represented below:

Chemical Structure
(click image for full-size original)
CLINICAL PHARMACOLOGY

Typical serum and urine levels following a single 150 mg dose of Coly-Mycin M Parenteral IM or IV in normal adult subjects are shown in Figure 1.

Figure
(click image for full-size original)
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 INDICATIONS AND USAGE section:

RX ITEM-Coly-Mycin M 150Mg Vial 1 By JHP
Item No.:RX110841 NDC No.42023010701 UPC No.:342023107015 NDC No. 42023-0107-01 42023010701 4202310701 42023-107-01 UPC/GTIN No. 3-42023-10701-5 342023107015 342023-107015 MPN 10701

Coly-Mycin M 150Mg Vial 1 By JHP Pharma
Item No.:RX110841 NDC No.42023010701 UPC No.:342023107015 NDC No. 42023-0107-01 42023010701 4202310701 42023-107-01 UPC/GTIN No. 3-42023-10701-5 342023107015 342023-107015 MPN 10701

COLISTIN (COLISTIMETHATE
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