:: What should I know about the safety of TOBI? ::
TOBI is generally safe. Please read the Important Safety Information below for people taking TOBI.
Information for Patients and Caregivers
TOBI® (Tobramycin Inhalation Solution, USP)
is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria
called Pseudomonas aeruginosa
. TOBI has not been studied in patients under 6 years of age, in those with a lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia. Ask your doctor if TOBI is right for you.
IMPORTANT SAFETY INFORMATION
If you are allergic to antibiotics in the same family as TOBI (ie, aminoglycosides), you should not take TOBI. Tell your doctor before starting treatment if you have any history of hearing, kidney, balance, or muscle problems.
Patients taking TOBI may have temporary side effects like coughing or difficulty breathing. Some people taking TOBI experienced ringing in the ears, hearing loss, or changes in voice (hoarseness)
. Ringing in the ears may be a warning sign for hearing loss. If you have ringing in the ears, changes in hearing, or dizziness, you should tell your doctor.
In studies, kidney damage was not seen in patients taking TOBI. However, antibiotics in the same family as TOBI have been linked to kidney damage.
If you are pregnant, plan to become pregnant, or if you are breast-feeding, talk with your doctor before taking TOBI.
Some drugs may interact with TOBI. Discuss all medications you are taking with your doctor.
Patients with cystic fibrosis can have many symptoms. Some of these may be related to your medications. You should tell your doctor if you have new or worsening symptoms.
Information for Patients and Caregivers
TOBI® (Tobramycin Inhalation Solution, USP) is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. TOBI has not been studied in patients under 6 years of age, in those with a lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia. Ask your doctor if TOBI is right for you.
IMPORTANT SAFETY INFORMATION
If you are allergic to antibiotics in the same family as TOBI (ie, aminoglycosides), you should not take TOBI. Tell your doctor before starting treatment if you have any history of hearing, kidney, balance, or muscle problems.
Patients taking TOBI may have temporary side effects like coughing or difficulty breathing.
Some people taking TOBI experienced ringing in the ears, hearing loss, or changes in
voice (hoarseness)
.
Ringing in the ears may be a warning sign for hearing loss. If you
have ringing in the ears, changes in hearing, or dizziness, you should tell your doctor.
In studies, kidney damage was not seen in patients taking TOBI. However, antibiotics in the same family as TOBI have been linked to kidney damage.
If you are pregnant, plan to become pregnant, or if you are breast-feeding, talk with your doctor before taking TOBI.
Some drugs may interact with TOBI. Discuss all medications you are taking with your doctor.
Patients with cystic fibrosis can have many symptoms. Some of these may be related to your medications. You should tell your doctor if you have new or worsening symptoms.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
