Foradil (Formoterol Fumarate Inhalation) - Summary

FORADIL SUMMARY

Foradil Aerolizer

FORADIL® AEROLIZER® consists of a capsule dosage form containing a dry powder formulation of FORADIL (formoterol fumarate) intended for oral inhalation only with the AEROLIZER® Inhaler.

FORADIL AEROLIZER is indicated for long-term, twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma, who require regular treatment with inhaled, short-acting, beta₂-agonists. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, shortacting, beta₂-agonists.

FORADIL AEROLIZER is also indicated for the acute prevention of exercise-induced bronchospasm (EIB) in adults and children 5 years of age and older, when administered on an occasional, as-needed basis.

FORADIL AEROLIZER can be used to treat asthma concomitantly with short-acting beta₂-agonists, inhaled or systemic corticosteroids, and theophylline therapy (see PRECAUTIONS, Drug Interactions). A satisfactory clinical response to FORADIL AEROLIZER does not eliminate the need for continued treatment with an anti-inflammatory agent.

FORADIL AEROLIZER is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease including chronic bronchitis and emphysema.

FORADIL NEWS HIGHLIGHTS

Published Studies Related to Foradil (Formoterol Inhalation)

Budesomide/ formoterol as maintenance and reliever treatment compared to fixed dose combination strategies - a Canadian economic evaluation. [2008.06]

Comparison of adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler and fixed-dose fluticasone propionate/salmeterol dry powder inhaler in asthma patients. [2008.06]

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]

Budesonide/formoterol maintenance and reliever therapy: impact on airway inflammation in asthma. [2008.05]

Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: A placebo-controlled trial. [2008.04]

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Clinical Trials Related to Foradil (Formoterol Inhalation)

Study of Arformoterol Tartrate Inhalation Solution and Racemic Formoterol in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) [Completed]

A Dose Ranging Study of Arformoterol Given Once Daily Compared to Arformoterol Given Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD) [Completed]

Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-Dose Inhaler (pMDI) or Oxis Turbuhaler [Completed]

A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) [Completed]

Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD [Completed]

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