TOBI is clear and slightly yellow, and may change in color.
With age, TOBI® (Tobramycin Inhalation Solution, USP)
may slightly change color, from light yellow to a darker yellow. This is normal as TOBI ages or as changes in temperature or exposure to light occur. TOBI should not be exposed to intense light. If TOBI is exposed to intense light, it will change color from light to dark yellow at a faster rate, and may eventually become brown with age.
A color change may not mean that there's any change in the quality of the product as long as it has been stored properly. TOBI is safe to use as it changes color as long as:
There are no particles floating in the solution
It is not cloudy
It has not been out of the refrigerator or at room temperature for more than 28 days
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.
