Name | Budesonide + Formoterol Fumarate |
Classes |
Respiratory Agent Antiasthmatic Antiasthmatic combination |
Diseases |
Asthma Chronic Obstructive Pulmonary Disease (COPD) Respiratory Disease |
English
Budesonide + Formoterol Fumarate
Budesonide + Formoterol Fumarate is a combination medication that contains an inhaled corticosteroid, budesonide, and a long-acting beta2-agonist bronchodilator, formoterol fumarate. Budesonide is a synthetic corticosteroid that reduces inflammation in the airways, while formoterol fumarate relaxes and opens the airways by stimulating beta2-adrenergic receptors.
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.
- 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
- 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.
Contraindication
Contraindicated in patients with hypersensitivity to any of the ingredients in Budesonide + Formoterol Fumarate.
None known.
Budesonide + Formoterol Fumarate is contraindicated in the primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures.