Symbicort (budesonide/formoterol)

SYMBICORT (budesonide and formoterol fumarate dihydrate inhalation) – a metered dose beta agonist-corticosteroid inhaler commonly used to treat asthma or chronic obstructive pulmonary disease . Inflammation is an important component in the development of COPD and asthma. Budesonide is a compound of the corticosteroid classes, members of which possess a wide range of inhibitory activities against multiple cell types and mediators involved in allergic and non-allergic mediated inflammation. These anti-inflammatory effects of corticosteroids (including budesonide) may contribute to their efficacy in COPD and asthma. Formoterol is a long-acting selective beta-2 adrenergic agonist. Beta-2 agonists are thought to produce their effects in asthma and COPD by relaxing bronchial smooth muscle and inhibiting the release of allergic mediators from cells, especially mast cells.

FDA approved uses: Symbicort is indicated for the treatment of asthma in patients 12 years of age and older; maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. Important limitations – Not indicated for relief of acute bronchospasms.

Available dosage forms: Aerosol inhalers 80 mg budesonide and 4.5 mg formoterol fumarate dihydrate; 160 mg budesonide and 4.5 mg formoterol fumarate dihydrate.
Usual dosage: Asthma in patients aged 12 years or more – 2 inhalations twice daily of Symbicort 80/4.5 or 160/4.5. Starting dose dependent on asthma severity. Maintenance treatment of airflow obstruction in COPD – 2 inhalations of Symbicort 160/4.5 twice daily.

Contraindications: Symbicort (budesonide and formoterol fumarate dihydrate inhalation hydrochloride) is contraindicated in – Primary treatment of status asthmaticus or acute asthma or COPD. Patients with known hypersensitivity to budesonide and formoterol fumarate dihydrate inhalation hydrochloride or to any excipients used in the formulation.

Special warnings: Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of 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 increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When treating patients with asthma, only prescribe SYMBICORT 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 SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids

Adverse reactions (side effects) of these medications: The most common side effects of Symbicort in the treatment of asthma include headache, upper respiratory infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis. The most common adverse events reported in the treatment of COPD include nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infections.

Common drug interactions: Strong cytochrome P450 3A4 inhibitors – Use with caution. May cause increased systemic corticosteroid effects. Monoamine oxidase inhibitors and tricyclic antidepressants – Use with extreme caution. May potentiate effects of formoterol on the vascular system. Beta blockers – may block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Diuretics – Use with caution. EKG changes and/or hypokalemia associated with non-potassium sparing diuretics may worsen with concomitant beta agonist use.

Special instructions for patients: Use this medication exactly as directed by physician. Not for acute symptoms. Symbicort is not meant to relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose. Consult official Medication Guide before starting Symbicort and when you receive additional refills.

Full prescribing information may be found at the manufacturer‘s official website Symbicort.com or at the U.S. Food and Drug Administration’s website at Symbicort Info at Drugs@FDA

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