WARNING Nephrotoxicity Bacitracin in parenteral (intramuscular) 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), and neomycin should be avoided.
ADVERSE REACTIONS 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. To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals USA, LLC at safety@xellia.com or 1-855-642-2594, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.