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Drug Notebook

Generic Name: tobramycin

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An aminoglycoside - treats Shunt Infection, Bacteremia, Skin or Soft Tissue Infection, Cystic Fibros... more

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, S_cr, and Cl_cr.
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?

Notify your doctor immediately if you develop ringing in the ears, dizziness, or changes in hearing during treatment with tobramycin.

To reduce the risk of illness, infection, or injury from contamination, you must thoroughly clean all parts of the nebulizer as directed after each treatment.

What is tobramycin?

Tobramycin is an antibiotic. It fights bacteria in the body.

Tobramycin inhalation is inhaled into the lungs using a nebulizer. Tobramycin inhalation is used to treat lung infections in patients with cystic fibrosis.

Tobramycin may also be used for purposes other than those listed here.

What should I discuss with my healthcare provider before using tobramycin?

Do not use tobramycin without first talking to your doctor if you have had an allergic reaction to an aminoglycoside antibiotic such as tobramycin (Nebcin, Tobi), gentamicin (Garamycin, others), amikacin (Amikin), kanamycin (Kantrex), streptomycin, paromomycin, or neomycin.

Talk to your doctor before using tobramycin if you have

hearing problems;
a neuromuscular disease such as myasthenia gravis or Parkinson's disease; or
kidney disease.

You may not be able to use tobramycin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Tobramycin is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Tobramycin is known to cause deafness in the baby when taken during pregnancy. Do not use tobramycin without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether tobramycin passes into breast milk. Do not use tobramycin without first talking to your doctor if you are breast-feeding a baby.

How should I use tobramycin?

Use tobramycin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Tobramycin is inhaled into the lungs with the use of a nebulizer. Do not swallow the solution by mouth.

Wash your hands with soap and water before preparing each treatment.

To use tobramycin inhalation:

Set up the nebulizer as directed.
Open one ampule of tobramycin solution for inhalation and squeeze the contents of the ampule into the nebulizer cup. Replace the nebulizer top.
Turn on the compressor. Check for a steady mist from the mouthpiece. If there is no mist, check all tubing connections and make sure the compressor is working.
Sit or stand in a position that will allow you to breathe normally. Place the mouthpiece of the nebulizer between your teeth and above your tongue and breathe normally only through your mouth. A noseclip may help you to breathe only through your mouth during a treatment. Continue breathing through the mouthpiece until all of the medicine is gone and no more mist is being produced. You may hear a sputtering sound when the nebulizer cup is empty. The entire treatment should take approximately 15 minutes to complete.
If you are interrupted or need to cough or rest during a treatment, turn the compressor off to save the medication. Turn the compressor back on when you are ready to resume treatment.

To reduce the risk of illness, infection, or injury from contamination, you must thoroughly clean all parts of the nebulizer as directed after each treatment.

If you are using several respiratory medications, the recommended order is bronchodilator first, followed by chest physiotherapy, then other inhaled medications, followed by tobramycin.

Do not use tobramycin that is cloudy or that has particles in it. Tobramycin stored at room temperature may become a darker color of yellow. This does not indicate any change in quality of the medication. Do not mix tobramycin with dornase alfa (Pulmozyme) or any other medications in the nebulizer.

Do not use tobramycin in bigger doses or more often than prescribed.

Use all of the tobramycin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. Store tobramycin in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius). If refrigeration is not available (e.g., when traveling), tobramycin may be stored at room temperature (77 degrees Fahrenheit/25 degrees Celsius) for up to 28 days. Avoid exposing ampules of tobramycin to direct light. Do not use tobramycin beyond the expiration date printed on the ampule.

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