Bacitracin

Bacitracin information, interactions and side effects, Sterile Bacitracin USP is an antibiotic for intramuscular administration. Bacitracin is derived from cultures of Bacillus subtilis (Tracey). It is a white to pale buff, hygroscopic powder, odorless or having a slight odor. It is freely soluble in water; insoluble in acetone, chloroform, and ether. While soluble in alcohol, methanol, and glacial acetic acid, there is some insoluble residue. It is precipitated from its solutions and inactivated by many of the heavy metals.

The structural formula is:

bacit1

bacitracin A
The molecular formula is: C66H103N17O16S. Bacitracin is comprised of a polypeptide complex and Bacitracin A is the major component in this complex. The molecular weight of Bacitracin A is 1422.71.

INDICATIONS

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).

HOW SUPPLIED

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).

SIDE EFFECTS

Nephrotoxic reactions. Albuminuria, cylindruria, azotemia. Rising blood levels without any increase in dosage.

Other reactions. Nausea and vomiting. Pain at site of injection. Skin rashes.

PRECAUTIONS

See “Warning Box” for precautions in regard to kidney toxicity associated with intramuscular use of bacitracin.

Adequate fluid intake should be maintained orally, or if necessary, by parenteral method.

As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.

Prescribing Bacitracin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

CONTRAINDICATIONS

This drug is contraindicated in those individuals with a history of previous hypersensitivity or toxic reaction to it.

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