BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE (Budesonide and Formoterol Fumarate Dihydrate) Nursing Considerations

What is the generic name?

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE

What is the Trade Name for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE?

Budesonide and Formoterol Fumarate Dihydrate

What are the Indications for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE?

• 1 INDICATIONS AND USAGE BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: Treatment of asthma in patients 6 years of age and older. ( 1.1 ) Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. ( 1.2 ) Important limitations: Not indicated for the relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is indicated for the treatment of asthma in patients 6 years of age and older. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA). Important Limitations of Use: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is also indicated to reduce exacerbations of COPD. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is the only strength indicated for the treatment of COPD. Important Limitations of Use: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is NOT indicated for the relief of acute bronchospasm.

References: https://open.fda.gov/