Baxter 2B0853 - Gentamicin Sulfate, 0.9% Sodium Chloride Injection, 100 mg/ 50 ml, Viaflex Plastic Container, Liquid Premix, 24/cs (Rx) (Continental US Only, Excluding IN and ND)

Baxter 2B0853 - Gentamicin Sulfate, 0.9% Sodium Chloride Injection, 100 mg/ 50 ml, Viaflex Plastic Container, Liquid Premix, 24/cs (Rx) (Continental US Only, Excluding IN and ND)

Baxter 2B0853 Gentamicin Sulfate, 0.9% Sodium Chloride Injection, 100 mg/ 50 ml, Viaflex Plastic Container

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Gentamicin Sulfate, USP, a water soluble antibiotic of the aminoglycoside group, is derived from Micromonospora purpurea, and actinomycete.

Gentamicin Sulfate in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution of Gentamicin Sulfate, USP in water for injection with 9 mg/mL sodium chloride (NaCl) to provide isotonicity. The solution is intended for intravenous use and requires no further dilution. pH may be adjusted with sulfuric acid or sodium hydroxide and is approximately 4.5.

This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX PLUS on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX PLUS plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Baxter 2B0853 Gentamicin Sulfate in 0.9% Sodium Chloride Injection Indication and Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Gentamicin Sulfate in 0.9% Sodium Chloride Injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter- Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative).

In serious infections when the causative organisms are unknown, Gentamicin Sulfate in 0.9% Sodium Chloride Injection may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.

Gentamicin injection has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused byPseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci.

Baxter 2B0853 Gentamicin Sulfate in 0.9% Sodium Chloride Injection Contraindications

Hypersensitivity to gentamicin is a contraindication to its use. A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of known cross-sensitivity of patients to drugs in this class.

How Supplied

Gentamicin Sulfate in 0.9% Sodium Chloride Injection in VIAFLEX PLUS plastic container is available in the following sizes and concentrations.