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Breyna Dosage

Generic name: budesonide 80ug, Formoterol Fumarate 4.5ug
Dosage form: aerosol, metered
Drug class: Bronchodilator combinations

Medically reviewed by Drugs.com. Last updated on Sep 14, 2023.

Administration Information

BREYNA should be administered as 2 inhalations twice daily (morning and evening, approximately 12 hours apart), every day by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing.

Prime BREYNA before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well before each spray and releasing two test sprays into the air away from the face.

More frequent administration or a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of BREYNA is not recommended as some patients are more likely to experience adverse effects with higher doses of formoterol. Patients using BREYNA should not use additional LABA for any reason [see Warnings and Precautions (5.3, 5.12)].

Asthma

If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Adult and Adolescent Patients 12 Years of Age and Older

For patients 12 years of age and older, the dosage is 2 inhalations of BREYNA 80 mcg/4.5 mcg or BREYNA 160 mcg/4.5 mcg twice daily.

The recommended starting dosages for BREYNA for patients 12 years of age and older are based upon patients’ asthma severity or level of control of asthma symptoms, and risk of exacerbations on current inhaled corticosteroids.

The maximum recommended dosage in adult and adolescent patients 12 years and older is BREYNA 160 mcg/4.5 mcg, two inhalations twice daily.

Improvement in asthma control following inhaled administration of BREYNA can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with BREYNA 80 mcg/4.5 mcg, replacement with BREYNA 160 mcg/4.5 mcg may provide additional asthma control.

If a previously effective dosage regimen of BREYNA fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, (e.g., replacing the lower strength of BREYNA with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.

Pediatric Patients Aged 6 to Less than 12 Years

For patients 6 to less than 12 years of age, the dosage is 2 inhalations of BREYNA 80 mcg/4.5 mcg twice daily.

Chronic Obstructive Pulmonary Disease

For patients with COPD the recommended dose is BREYNA 160 mcg/4.5 mcg, two inhalations twice daily.

If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Frequently asked questions

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