Tobramycin warnings and precautions

# Warnings and Precautions

## Warnings
Caution should be exercised when prescribing TOBI to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant parenteral aminoglycoside therapy should be monitored as clinically appropriate.
Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use TOBI during pregnancy, or become pregnant while taking TOBI should be apprised of the potential hazard to the fetus.

### Ototoxicity
Ototoxicity, as measured by complaints of hearing loss or by audiometric evaluations, did not occur with TOBI therapy during clinical studies. However, transient tinnitus occurred in eight TOBI-treated patients versus no placebo patients in the clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution (see ADVERSE REACTIONS). Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.
In postmarketing experience, patients receiving TOBI have reported hearing loss. Some of these reports occurred in patients with previous or concomitant treatment with systemic aminoglycosides. Patients with hearing loss frequently reported tinnitus.

### Nephrotoxicity
Nephrotoxicity was not seen during TOBI clinical studies but has been associated with aminoglycosides as a class. If nephrotoxicity occurs in a patient receiving TOBI, tobramycin therapy should be discontinued until serum concentrations fall below 2 g/mL.

### Muscular Disorders
TOBI should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinsons disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.

### Bronchospasm
Bronchospasm can occur with inhalation of TOBI. In clinical studies of TOBI, changes in FEV1 measured after the inhaled dose were similar in the TOBI and placebo groups.
Bronchospasm should be treated as medically appropriate.

## Precautions

### Information for Patients
NOTE: In addition to information provided below, a Patient Medication Guide providing instructions for proper use of TOBI is contained inside the package.

### Safety Information
TOBI is in a class of antibiotics that have caused hearing loss, dizziness, kidney damage, and harm to a fetus. Ringing in the ears and hoarseness were two symptoms that were seen in more patients taking TOBI than placebo in research studies. Patients with cystic fibrosis can have many symptoms. Some of these symptoms may be related to your medications. If you have new or worsening symptoms, you should tell your doctor.
- Hearing: You should tell your doctor if you have ringing in the ears, dizziness, or any changes in hearing.
- Kidney Damage: Inform your doctor if you have any history of kidney problems.
- Pregnancy: If you want to become pregnant or are pregnant while on TOBI, you should talk with your doctor about the possibility of TOBI causing any harm.
- Nursing Mothers: If you are nursing a baby, you should talk with your doctor before using TOBI.