BREYNA

Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol

AbsorptionBudesonide Healthy Subjects: Orally inhaled budesonide is rapidly absorbed in the lungs and peak concentration is typically reached within 20 minutes. After oral administration of budesonide peak plasma concentration was achieved in about 1 to 2 hours and the absolute systemic availability was 6%-13% due to extensive first pass metabolism. In contrast, most of the budesonide delivered to the lungs was systemically absorbe...

14.1 Asthma Patients with Asthma 12 Years of Age and Older In two clinical studies comparing budesonide and formoterol fumarate dihydrate inhalation aerosol with the individual components, improvements in most efficacy end points were greater with budesonide and formoterol fumarate dihydrate inhalation aerosol than with the use of either budesonide or formoterol alone. In addition, one clinical study showed similar results between budesonide and formoterol fumarate dihydrate inhalation aerosol and the concurrent use of budesonide and formoterol at corresponding doses from separate inhalers. Th...

LABA use may result in the following:

• Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1) ] .
• Cardiovascular and central nervous system effects [see Warnings and Precautions (5.12) ] . Systemic and inhaled corticosteroid use may result in the following:
• Candida albicans infection [see Warnings and Precautions (5.4) ]
• Pneumonia or lower respiratory tract infections in patients with COPD [see Warnings and Precautions (5.5) ]
• Immunosupp...

The use of BREYNA is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
• Hypersensitivity to any of the ingredients in BREYNA.
• Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures ( 4 )
• Hypersensitivity to any of the ingredien...

• Serious asthma-related events: Long-acting beta 2 -adrenergic agonists as monotherapy increase the risk. ( 5.1 )
• Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or COPD or to treat acute symptoms. ( 5.2 )
• Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose. ( 5.3 )
• Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adv...

7 DRUG INTERACTIONS In clinical studies, concurrent administration of budesonide and formoterol fumarate dihydrate inhalation aerosol and other drugs, such as short-acting beta 2 -agonists, intranasal corticosteroids, and antihistamines/decongestants has not resulted in an increased frequency of adverse reactions. No formal drug interaction studies have been performed with budesonide and formotero...