Recommended Dosage and Administration

The recommended dosage of BREZTRI AEROSPHERE is budesonide 320 mcg, glycopyrrolate 18 mcg and formoterol fumarate 9.6 mcg (administered as 2 inhalations of BREZTRI AEROSPHERE [budesonide/glycopyrrolate/formoterol fumarate 160 mcg/9 mcg/4.8 mcg]) twice daily, in the morning and in the evening, by oral inhalation. Do not take more than two inhalations twice daily.

After inhalation, rinse mouth with water without swallowing.

Preparation

Prime BREZTRI AEROSPHERE before using for the first time. Priming BREZTRI AEROSPHERE is essential to ensure appropriate drug content in each actuation. Prime BREZTRI AEROSPHERE by releasing 4 sprays into the air away from the face, shaking well before each spray.

If the inhaler has not been used for more than 7 days, is dropped, or after weekly rinsing, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well before each spray.

Dose counter

BREZTRI AEROSPHERE canister has an attached dose indicator (also known as puff indicator), which indicates how many inhalations (puffs) remain. The dose indicator display has a pointer which will move after every actuation. When nearing the end of the usable inhalations, the pointer is in the yellow zone. BREZTRI AEROSPHERE should be discarded when the pointer is at zero which is in the red zone.