Budesonidedosage

For oral inhalation only.

Prime BREZTRI AEROSPHERE before first time use and re-prime if not used for more than 7 days.

Maintenance treatment of COPD: 2 inhalations of BREZTRI AEROSPHERE 160 mcg/9 mcg/4.8 mcg twice daily administered by oral inhalation.

Maintenance treatment of asthma: 2 inhalations of BREZTRI AEROSPHERE 160 mcg/18 mcg/4.8 mcg twice daily administered by oral inhalation.

2.1 Preparation and

Administration Information BREZTRI AEROSPHERE should be administered as 2 inhalations 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. Priming Before Use Priming BREZTRI AEROSPHERE is essential to ensure appropriate drug content in each actuation. Prime BREZTRI AEROSPHERE before using for the first time. Prime BREZTRI AEROSPHERE by releasing 4 sprays into the air away from the face, shaking well before each spray. Re-prime BREZTRI AEROSPHERE if the inhaler has not been used for more than 7 days, is dropped, or after weekly rinsing. Prime BREZTRI AEROSPHERE 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 in the red zone of the dose indicator.

2.2 Recommended

Dosage for Maintenance Treatment of Chronic Obstructive Pulmonary Disease The recommended dosage of BREZTRI AEROSPHERE for treatment of COPD is budesonide 320 mcg, glycopyrrolate 18 mcg, and formoterol fumarate 9.6 mcg (administered as 2 inhalations of BREZTRI AEROSPHERE 160 mcg/9 mcg/4.8 mcg [budesonide 160 mcg, glycopyrrolate 9 mcg, and formoterol fumarate 4.8 mcg]) twice daily, in the morning and in the evening, by oral inhalation.

2.3 Recommended

Dosage for Maintenance Treatment of Asthma The recommended dosage of BREZTRI AEROSPHERE for maintenance treatment of asthma is budesonide 320 mcg, glycopyrrolate 36 mcg, and formoterol fumarate 9.6 mcg (administered as 2 inhalations of BREZTRI AEROSPHERE 160 mcg/18 mcg/4.8 mcg [budesonide 160 mcg, glycopyrrolate 18 mcg, and formoterol fumarate 4.8 mcg]) twice daily, in the morning and in the evening, by oral inhalation.

2.1 Preparation and

Administration Information BREZTRI AEROSPHERE should be administered as 2 inhalations 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. Priming Before Use Priming BREZTRI AEROSPHERE is essential to ensure appropriate drug content in each actuation. Prime BREZTRI AEROSPHERE before using for the first time. Prime BREZTRI AEROSPHERE by releasing 4 sprays into the air away from the face, shaking well before each spray. Re-prime BREZTRI AEROSPHERE if the inhaler has not been used for more than 7 days, is dropped, or after weekly rinsing. Prime BREZTRI AEROSPHERE 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 in the red zone of the dose indicator.

2.2 Recommended

Dosage for Maintenance Treatment of Chronic Obstructive Pulmonary Disease The recommended dosage of BREZTRI AEROSPHERE for treatment of COPD is budesonide 320 mcg, glycopyrrolate 18 mcg, and formoterol fumarate 9.6 mcg (administered as 2 inhalations of BREZTRI AEROSPHERE 160 mcg/9 mcg/4.8 mcg [budesonide 160 mcg, glycopyrrolate 9 mcg, and formoterol fumarate 4.8 mcg]) twice daily, in the morning and in the evening, by oral inhalation.

2.3 Recommended

Dosage for Maintenance Treatment of Asthma The recommended dosage of BREZTRI AEROSPHERE for maintenance treatment of asthma is budesonide 320 mcg, glycopyrrolate 36 mcg, and formoterol fumarate 9.6 mcg (administered as 2 inhalations of BREZTRI AEROSPHERE 160 mcg/18 mcg/4.8 mcg [budesonide 160 mcg, glycopyrrolate 18 mcg, and formoterol fumarate 4.8 mcg]) twice daily, in the morning and in the evening, by oral inhalation.