Budesonide / Formoterol Fumarate

What it is and how it works

Mechanism of Action BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL contains both budesonide and formoterol; therefore, the mechanisms of action described below for the individual components apply to BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. These drugs represent two classes of medications (a synthetic corticosteroid and a long-acting selective beta 2 -adrenoceptor agonist) that have different effects on clinical, physiological, and inflammatory indices of COPD and asthma.

Mechanism class: Corticosteroid Hormone Receptor Agonists

Indications

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. • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. Important limitations: • Not indicated for the relief of acute bronchospasm. ( 1.1 , 1.2 ) 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.

Dosage and administration (summary)

For oral inhalation only. • Treatment of asthma in patients 12 years and older: 2 inhalations of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 or 160/4.5 twice daily. Starting dosage is based on asthma severity. • Treatment of asthma in patients aged 6 to less than 12 years: 2 inhalations of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 twice daily. • Maintenance treatment in COPD: 2 inhalations of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 twice daily.

Contraindications

The use of budesonide and formoterol fumarate dihydrate 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 BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures.

Warnings and precautions

• Serious asthma-related events: Long-acting beta2-adrenergic agonists as monotherapy increase the risk. • Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or COPD or to treat acute symptoms. • Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose. • Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity.

Pregnancy

Pregnancy Risk Summary There are no adequate and well-controlled studies of budesonide and formoterol fumarate dihydrate or one of its individual components, formoterol fumarate, in pregnant women; however studies are available for the other component budesonide.

Storage and supply

Product: 50090-6327 NDC: 50090-6327-0 1 AEROSOL in a POUCH / 1 in a CARTON

Source: Budesonide And Formoterol Fumarate Dihydrate (Budesonide And Formoterol Fumarate Dihydrate) — US FDA prescribing information, 2023-02-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.