BACIJECT

1 Dosing Considerations Bacitracin should be used only where adequate laboratory facilities are available and when constant supervision of the patient is possible. To reduce the development of drug-resistant bacteria and maintain the effectiveness of BaciJect and other antibacterial drugs, BaciJect should be used only to treat 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.

Renal function should be carefully determined prior to, and daily during therapy. Adequate fluid intake should be maintained orally, or if necessary, by parenteral method. 2 Recommended Dose and Dosage Adjustment. 2 Recommended Dose and Dosage Adjustment 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.

3 Reconstitution INTRAMUSCULAR Use 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. 8 mL of diluent will result in a concentration of 5,000 units per mL. Reconstituted solution should be clear, pale yellow to light brown in colour and free of foreign particles.

4 Administration Bacitracin solutions, applied locally in the form of compresses or instillations, may be used once or twice daily in secondarily infected wounds, ulcers, pyodermas and other superficial skin infections and in superficial infections of the eye caused by bacitracin-susceptible organisms.

Bacitracin solutions may be instilled into the nasal cavities or administered by inhalation as an aerosol in the treatment of bacitracin- susceptible infections of the upper and lower respiratory tract. In severe or extensive infections, appropriate antibacterial therapy should be given in addition to local treatment with bacitracin.

1 Adverse Reaction Overview Nephrotoxic reactions: Albuminuria, Cylindruria Azotemia. Rising blood levels without any increase in dosage (see 7 WARNINGS AND PRECAUTIONS, Renal).

Other reactions:

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

, General; Renal). • Serious hypersensitivity and/or anaphylactic reactions have been reported in patients exposed to bacitracin (see 7 WARNINGS AND PRECAUTIONS, Immune). 1 Dosing Considerations Bacitracin should be used only where adequate laboratory facilities are available and when constant supervision of the patient is possible.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BaciJect and other antibacterial drugs, BaciJect should be used only to treat 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.

Renal function should be carefully determined prior to, and daily during therapy. Adequate fluid intake should be maintained orally, or if necessary, by parenteral method. 2 Recommended Dose and Dosage Adjustment. 2 Recommended Dose and Dosage Adjustment 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.

3 Reconstitution INTRAMUSCULAR Use 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. 8 mL of diluent will result in a concentration of 5,000 units per mL. Reconstituted solution should be clear, pale yellow to light brown in colour and free of foreign particles.