Aminoglycosides can cause fetal harm (e.g., congenital deafness) when administered to a pregnant woman. No adequate and well-controlled studies of TOBI Podhaler in pregnant women have been conducted. If TOBI Podhaler is used during pregnancy, or if the patient becomes pregnant while taking TOBI Podhaler, the patient should be apprised of the potential hazard to the fetus.

8.3 Nursing Mothers
The amount of tobramycin excreted in human breast milk after administration by inhalation is not known. Because of the potential for ototoxicity and nephrotoxicity in infants, a decision should be made whether to terminate nursing or discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use
Patients 6 years and older were included in the Phase 3 studies with TOBI Podhaler; 206 patients below 20 years of age received TOBI Podhaler. No dosage adjustments are needed based on age. The overall pattern of adverse events in pediatric patients was similar to the adults. Dysgeusia (taste disturbance) was more commonly reported in younger patients six to 19 years of age than in patients 20 years and older, 7.4% vs 2.7%, respectively. Safety and effectiveness in pediatric patients below the age of 6 years have not been established.

8.5 Geriatric Use
Clinical studies of TOBI Podhaler did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see Warnings and Precautions (5.2, 5.5)].

8.6 Renal Impairment
Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin. The risk of adverse reactions to this drug may be greater in patients with impaired renal function. Patients with serum creatinine > 2 mg/dL and blood urea nitrogen (BUN) > 40 mg/dL have not been included in clinical studies and there are no data in this population to support a recommendation regarding dose adjustment with TOBI Podhaler [see Warnings and Precautions (5.2, 5.5)].

8.7 Hepatic Impairment
No studies have been performed in patients with hepatic impairment. As tobramycin is not metabolized, an effect of hepatic impairment on the exposure to tobramycin is not expected.

8.8 Organ Transplantation
Adequate data do not exist for the use of TOBI Podhaler in patients after organ transplantation.

10 OVERDOSAGE
The maximum tolerated daily dose of TOBI Podhaler has not been established.

In the event of accidental oral ingestion of TOBI Podhaler capsules, systemic toxicity is unlikely as tobramycin is poorly absorbed. Tobramycin serum concentrations may be helpful in monitoring overdosage.

Acute toxicity should be treated with immediate withdrawal of TOBI Podhaler, and baseline tests of renal function should be undertaken.

Hemodialysis may be helpful in removing tobramycin from the body.

In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. In the case of any overdosage, the