Tobramycin (Systemic)

Warning

Neurotoxicity and Ototoxicity

• Neurotoxicity (manifested as both auditory and vestibular ototoxicity) can occur. Other neurotoxicity manifestations include numbness, skin tingling, muscle twitching, and seizures.

• Eighth-cranial nerve impairment develops principally in patients with preexisting renal damage and in those with normal renal function who receive doses higher or treatment longer than recommended.

• Aminoglycoside-induced ototoxicity is irreversible, usually bilateral, and may be partial or total.

• Risk of hearing loss increases with degree of exposure to either high peak or high trough serum concentrations.

• Patients developing cochlear damage may not have symptoms during aminoglycoside treatment to warn them of eighth-cranial nerve toxicity and total or partial, irreversible, bilateral deafness may occur after drug discontinued.

Nephrotoxicity

• Potentially nephrotoxic.

• Aminoglycoside-induced nephrotoxicity usually is reversible.

• Nephrotoxicity develops principally in patients with preexisting renal damage and in those with normal renal function who receive doses higher or treatment longer than recommended.

• Rarely, nephrotoxicity may become apparent several days after discontinuance.

Patient Monitoring

• Patients should be under close clinical observation because of potential ototoxicity and nephrotoxicity.

• Closely monitor renal and eighth-cranial nerve function, especially in patients with known or suspected renal impairment at start of treatment and also in those whose renal function is initially normal but who develop renal dysfunction during treatment.

• Monitor serum tobramycin concentrations periodically to ensure adequate concentrations and avoid potentially toxic and prolonged peak concentrations (>12 mcg/mL).