Mycin Warnings

Gentamicin sulfate 40 mg/mL inj. contains sodium metabisulfite 0.32%, a sulfite that may cause serious allergic type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite toxicity in the general population is unknown and probably low. Sulfite sensitivity is been more in asthmatic than in non-asthmatic people. Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use. Nephrotoxicity, manifested by ototoxicity, both vestibular and auditory, can occur particularly in patients with existing renal damage. Renal and eighth cranial nerve function should be closely monitored. Urine should be examined for decreased specific gravity, increased excretion of protein and presence of cells or casts. BUN, serum creatinine or creatinine clearance should be monitored. Evidence of ototoxicity requires dosage adjustment or discontinuation of use for the drug. Serum concentrations should be monitored and the dosage adjusted so that prolonged levels above 12 mcg/mL are avoided. In the event of overdosage or toxic reactions, hemodialysis may aid in removal of the drug. Concurrent and/or sequential use of potentially neurotoxic/nephrotoxic drugs such as cisplatin, cephaloridine, kanamycin, amikacin, neomycin, polymixin B, colistin, paromomycin, streptomycin, tobramycin, vancomycin and viomycin should be avoided. Concurrent use with potent diuretics such as furosemide and ethacrynic acid should be avoided. When administered intravenously, diuretics may enhance aminoglycoside toxicity by altering the antibiotic concentration in serum and tissue.
Aminoglycosides can cause fetal harm when administered to a pregnant woman. Animal reproduction studies conducted on rats and rabbits did not reveal evidence of impaired fertility or harm to the fetus due to gentamicin sulfate. It is not known whether gentamicin sulfate can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity. If gentamicin is used during pregnancy or if the patient becomes pregnant while taking gentamicin, she should be aprised of the potential hazard to the fetus.