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 BRAND NAMES
- Brazil: Vannair
- Denmark: Rilast
- India: Foracort
- International: Symbicort
- Italy: Assieme, Sinestic, Symbicort
- Spain: Rilast
- U.S.: Symbicort PI
 MECHANISM OF ACTION
Budesonide is an inhaled glucocorticoid, it works in the air passages of the lungs by reducing inflammation and keeping the airways open, making it easier to breathe. Glucocorticoids have multiple antiinflammatory effects, inhibiting both inflammatory cells and release of inflammatory mediators.
Formoterol is a long acting Beta2 agonist with a fast onset of action. Beta2 receptors are the predominant adrenergic receptors in bronchial smooth muscle. The binding of Formoterol to Beta2 adrenergic receptors in bronchial smooth muscle, activates the intracellular adenylate cyclase, an enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic adenosine monophosphate (cAMP). The increase of cAMP determines:
- Inhibition of the release of mast cell mediators
- Increased mucociliary clearance
- Treatment of asthma in patients aged 12 years and older.
- Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD)
Budesonide/Formoterol (inhaler) combination is not indicated for the relief of acute bronchospasm
- ASTHMA: Adults and children over 12 years: 2 inhalations of Budesonide/Formoterol 80/4,5 or 160/4,5 , twice daily, based on asthma severity
- Maintenance treatment of COPD: 2 inhalations of Budesonide/Formoterol 160/4,5 , twice daily.
- Acute episodes of asthma or COPD requiring intensive measures
- Hypersensitivity to any of the ingredients
 WARNINGS AND PRECAUTIONS
- Long-acting beta2-adrenergic agonists (LABA), such as formoterol, increase the risk of asthma-related death. A placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABAs, including formoterol. Currently available data are inadequate to determine whether concurrent use of an inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. .
- When treating patients with asthma, Budesonide/Formoterol combination should be prescribed only for patients not adequately controlled on a long-term asthma-control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue Budesonide/Formoterol (Inhaler)) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhalded corticosteroid. Do not use Budesonide/Formoterol (Inhaler) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
- Deterioration of Disease and Acute Episodes: Budesonide/Formoterol (Inhaler) should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. An inhaled, short-acting beta2-agonist (e.g. Salbutamol), should be used to relieve acute symptoms such as shortness of breath.
- Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
- Candida albicans infection of the mouth and pharynx. Monitor patients periodically for signs of adverse effects in the mouth and pharynx. Advise patients to rinse mouth after inhalation.
- 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.
- Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids
- Glaucoma, increased intraocular pressure, and cataracts have been reported following the long-term administration of inhaled corticosteroids.
- Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients
- Paradoxical bronchospasm may occur. Treat bronchospasm immediately with a fast-acting inhaled bronchodilator (Salbutamol) and discontinue Budesonide/Formoterol (Inhaler).
- 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
- Patients using Budesonide/Formoterol (Inhaler) should not use an additional LABA (e.g., salmeterol, formoterol , arformoterol) for any reason. (Because of overdose risk and significant cardiovascular effects and fatalities)
- The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Budesonide/Formoterol (Inhaler) is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur.
- Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Use of a cardioselective beta-receptor blocker must be considered.
- Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of Formoterol on vascular system.
 PREGNANCY AND LACTATION
- Pregnancy Category C (US), Budesonide/Formoterol (Inhaler) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Since there are no data from controlled trials on the use of Budesonide/Formoterol (Inhaler) by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account its importance to the mother.
 SIDE EFFECTS
Most common adverse reactions are: nasopharyngitis, headache, upper respiratory tract infection, pharygolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.