Symbicort (Budesonide Inhalation) - Summary

SYMBICORT SUMMARY

SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only.

SYMBICORT is indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.

Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. SYMBICORT is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta₂-agonists.

SYMBICORT is NOT indicated for the relief of acute bronchospasm.

SYMBICORT NEWS HIGHLIGHTS

Published Studies Related to Symbicort (Budesonide Inhalation)

Early bronchodilatory effects of budesonide/formoterol pMDI compared with fluticasone/salmeterol DPI and albuterol pMDI: 2 randomized controlled trials in adults with persistent asthma previously treated with inhaled corticosteroids. [2008.05]

Relative systemic availability of budesonide in patients with asthma after inhalation from two dry powder inhalers. [2008.05]

The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up: effectiveness of early intervention with budesonide in mild persistent asthma. [2008.05]

Long-term effects of budesonide on inflammatory status in COPD. [2008.04]

Bronchodilation of formoterol administered with budesonide: Device and formulation effects. [2008.03]

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Clinical Trials Related to Symbicort (Budesonide Inhalation)

Symbicort Rapihaler Therapeutic Equivalence Study [Completed]

Long-Term Safety of Symbicort in Asthmatic Children - SAPLING [Completed]

Atlantis Symbicort [Completed]

Gemini Symbicort pMDI [Completed]

A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler® [Completed]

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