Pharmacia & Upjohn


Action And Clinical Pharmacology: Bacitracin, an antibiotic substance derived from cultures of B. subtilis (Tracey), exerts pronounced antibacterial action in vitro against a variety of gram-positive and a few gram-negative organisms.

However, among systemic diseases, only staphylococcal infections qualify for consideration of bacitracin therapy. Bacitracin is assayed against a standard and its activity is expressed in units, 1 mg having a potency of not less than 50 units.

Susceptibility Plate Testing: If the Kirby-Bauer method of disc susceptibility is used, a 10-unit bacitracin disc should give a zone over 13 mm when tested against a bacitracin-susceptible strain of S. aureus. Absorption of bacitracin following i.m. injection is rapid and complete. A dose of 200 or 300 units/kg every 6 hours gives serum levels of 0.2 to 2 µg/mL in individuals with normal renal function. The drug is excreted slowly by glomerular filtration. It is widely distributed in all body organs and is demonstrable in ascitic and pleural fluids after i.m. injection.

Indications And Clinical Uses: The use of i.m. bacitracin is indicated in the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.

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.

Contra-Indications: In those individuals with a history of previous hypersensitivity or toxic reaction to it.

Manufacturers’ Warnings In Clinical States: I.M.: Nephrotoxicity: Bacitracin in parenteral (i.m.) therapy may cause renal failure due to tubular and glomerular necrosis. Its use should be restricted to infants with staphylococcal pneumonia and empyema when due to organisms shown to be susceptible to bacitracin. It should be used only where adequate laboratory facilities are available and when constant supervision of the patient is possible.

Renal function should be carefully determined prior to and daily during therapy. The recommended daily dose should not be exceeded and fluid intake and urinary output maintained at proper levels to avoid kidney toxicity. If renal toxicity occurs the drug should be discontinued. The concurrent use of other nephrotoxic drugs, particularly streptomycin, kanamycin, polymyxin B, polymyxin E (colistin), neomycin, and viomycin, should be avoided.

Precautions: See Warnings for precautions in regard to kidney toxicity associated with i.m. 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.

Adverse Reactions: Nephrotoxic: albuminuria, cylindruria, azotemia, rising blood levels without any increase in dosage.

Others: nausea and vomiting. Pain at site of injection. Skin rashes.

Dosage And Administration: To be administered i.m.

Infants: For infants under 2 500 g: 900 units/kg/24 hours in 2 or 3 divided doses. For infants over 2 500 g: 1 000 units/kg/24 hours in 2 or 3 divided doses. I.M. 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% procaine. The concentration of the antibiotic in the solution should not be less than 5 000 units/mL nor more than 10 000 units/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/mL.

To be administered topically.

Preparation of Solution: Solutions for topical application are prepared by dissolving bacitracin in Sterile Water for Injection or Sodium Chloride Injection in amounts to give the following concentrations: skin, 500 units/mL; ophthalmic solutions, 500 to 1 000 units/mL; intranasal therapy, 250 units/mL; aerosol, 500 to 1 000 units/mL.

Availability And Storage: Each vial contains: bacitracin 50 000 units. Store unreconstituted bacitracin in a refrigerator 2 to 8°C. Solutions are rapidly inactivated at room temperature but are stable for 1 week when stored in a refrigerator 2 to 8°C.

BACITRACIN Pharmacia & Upjohn Antibiotic

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