Amikacide Special Precautions

This product contains metabisulfite which may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Safety for treatment periods longer than 14 days has not been established.
Patients treated with parenteral aminoglycosides should be under close clinical observation. Amikacin sulfate injection is potentially nephrotoxic, ototoxic and neurotoxic. Avoid concurrent use of other ototoxic or nephrotoxic agents because of the potential additive effects.
Patients with preexisting tinnitus, vertigo, subclinical high-frequency hearing loss, or renal impairment and patients who are receiving high doses and/or prolonged therapy with aminoglycosides or who have received prior ototoxic drugs are especially susceptible to ototoxicity and should be carefully observed for signs of eighth cranial nerve damage during aminoglycoside therapy.
Assess kidney function by the usual methods prior to starting therapy and daily during the course of treatment. If signs of renal irritation appear, increase hydration. A reduction in dosage may be recommended if other evidence or renal dysfunction occurs such as decreased creatinine clearance, decreased urine specific gravity, and increased BUN, creatinine or oliguria. Stop the treatment if azotemia increases or if a progressive decrease in urinary output occurs.
Amikacin should be used with caution in patients with neuromuscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular function.
Use of amikacin may result in overgrowth of nonsusceptible organisms. If this occurs, appropriate therapy should be instituted.
General: Prescribing amikacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patients and increases the risk of the development of drug-resistant bacteria.
Use in Children: Use amikacin with caution and in reduced dose in premature and full-term neonates because of the renal immaturity of these patients and resulting prolongation of serum half-life of the drug.
Use in Elderly: Special care is required when using amikacin in the elderly in whom renal function may be impaired, as old age appears to be an independent risk factor for ototoxicity and nephrotoxicity. Measure blood levels frequently and give the drug for no longer than is essential.