Drug Notebook

FDA Alerts

    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).
  • Rising trough concentrations (>2 mcg/mL) may indicate tissue accumulation.
  • Tissue accumulation, excessive peak concentrations, cumulative dose, advanced age, and dehydration may contribute to ototoxicity and nephrotoxicity.
  • Evaluate urine for decreased specific gravity and increased excretion of protein, cells, and casts; periodically determine BUN, Scr, and Clcr.
  • When feasible, perform serial audiograms in patients old enough to be tested, particularly high-risk patients.
  • Discontinue tobramycin or adjust dosage if there is evidence of impaired renal, vestibular, or auditory function.
  • Use with caution in neonates and premature infants because of their renal immaturity and prolonged tobramycin serum half-life.
    Interactions
  • Avoid concurrent and/or sequential use of other neurotoxic or nephrotoxic drugs, particularly other aminoglycosides, cephaloridine (no longer available in US), viomycin, polymyxin B, colistin, cisplatin, and vancomycin.
  • Avoid concurrent use of potent diuretics (e.g., ethacrynic acid, furosemide) since diuretics themselves may cause ototoxicity and IV diuretics enhance toxicity by altering serum and tissue aminoglycoside concentrations.
    Pregnancy
  • Aminoglycosides can cause fetal harm when administered to a pregnant woman.

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(toe bra MY sin)

What is the most important information I should know about tobramycin injection?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

There may be other drugs that can affect tobramycin injection. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Contact your doctor promptly if you have any hearing loss or ringing in your ears, even if these side effects occur long after you have stopped using tobramycin injection.

Other serious side effects include urinating less than usual or not at all, muscle stiffness or uncontrolled twitching, and wheezing, chest tightness, or trouble breathing.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Tobramycin injection will not treat a viral infection such as the common cold or flu. Tobramycin injection can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What is tobramycin injection?

Tobramycin is in a group of antibiotics called aminoglycosides (ah-meen-oh-GLY-ko-sides). Tobramycin fights infections that are caused by bacteria.

Tobramycin injection is used to treat bacterial infections of the skin, heart, stomach, brain and spinal cord, respiratory system, and urinary tract. It is also used in the treatment of cystic fibrosis. Tobramycin injection is sometimes used together with other antibiotics.

Tobramycin may also be used for other purposes not listed in this medication guide.

What should I discuss with my health care provider before using tobramycin injection?

Do not use this medication if you are allergic to tobramycin or other aminoglycosides such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), netilmicin (Netromycin), or streptomycin.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may need a dose adjustment or special tests to safely use tobramycin.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use tobramycin injection without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Tobramycin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.
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