"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
In accord with the statements in the "Warning Box" the use of intramuscular bacitracin is limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bacitracin and other antibacterial drugs, Bacitracin 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.
DOSAGE AND ADMINISTRATION
TO BE ADMINISTERED INTRAMUSCULARLY ONLY
Infant dose: For infants under 2500 grams-900 units/kg/24 hours in 2 or 3 divided doses. For infants over 2500 grams-1,000 units/kg/24 hours, in 2 or 3 divided doses. Intramuscular injections of the solution should be given in the upper outer quadrant of the buttocks, alternating right and left and avoiding multiple injections in the same region because of the transient pain following injection.
Preparation of Solutions-Should be dissolved in sodium chloride injection containing 2 percent procaine hydrochloride. The concentration of the antibiotic in the solution should not be less than 5,000 units per mL nor more than 10,000 units per mL.
Diluents containing parabens should not be used to reconstitute bacitracin; cloudy solutions and precipitate formation have occurred.
Reconstitution of the 50,000 unit vial with 9.8 mL of diluent will result in a concentration of 5,000 units per mL.
Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).
Sterile Bacitracin USP is available in a vial containing 50,000 units (NDC 0009-0233-01). Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F).
Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, Michigan 49001, USA. Revised September 2003. FDA Rev date: 4/5/2000
Last reviewed on RxList: 5/5/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Bacitracin Information
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