Budesonide + Formoterol Fumarate is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) and to reduce exacerbations in patients with a history of exacerbations. It is also indicated for the treatment of asthma in patients aged 12 years and older who require both an inhaled corticosteroid and a long-acting beta2-agonist.

Asthma

Chronic Obstructive Pulmonary Disease (COPD)

• For COPD: The recommended dose is one inhalation of Budesonide + Formoterol Fumarate 160/4.5 mcg twice daily.
• For asthma: The recommended dose is based on the patient's asthma severity, previous asthma therapy, and current control of asthma symptoms. The usual starting dose is one inhalation of Budesonide + Formoterol Fumarate 80/4.5 mcg or 160/4.5 mcg twice daily.

The following side effects have been reported with the use of Budesonide + Formoterol Fumarate

• Headache
• Nasopharyngitis
• Upper respiratory tract infection
• Back pain
• Oral candidiasis
• Congestion
• Nausea
• Dyspnea
• Sinusitis
• Throat irritation

Headache	Nasopharyngitis	URTI (Upper Respiratory Tract Infection)
Back Pain	Oropharyngeal candidiasis	Congestion

• Asthma-related death: Long-acting beta2-adrenergic agonists increase the risk. Prescribe only for recommended patient populations.
• Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or to treat acute symptoms. 
• Use with additional long-acting beta2-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. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
• Pneumonia: Increased risk in patients with COPD. Monitor patients for signs and symptoms of pneumonia and other potential lung infections. 
• Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
• Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to Budesonide + Formoterol Fumarate.
• Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Budesonide + Formoterol Fumarate slowly. 
• Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid effects. Exercise caution when used with Budesonide + Formoterol Fumarate. 
• Paradoxical bronchospasm: Discontinue Budesonide + Formoterol Fumarate and institute alternative therapy if paradoxical bronchospasm occurs.
• Patients with cardiovascular or central nervous system disorders: Use with caution because of beta-adrenergic stimulation. 
• Decreases in bone mineral density: Assess bone mineral density initially and periodically thereafter.
• Effects on growth: Monitor growth of pediatric patients.
• Glaucoma and cataracts: Close monitoring is warranted. 
• Metabolic effects: Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. 
• Coexisting conditions: Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.