WARNING: ASTHMA RELATED DEATH
Long-acting beta
2
-adrenergic agonists (LABA), such as formoterol the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol (see WARNINGS). 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.
Because of this risk, use of FORADIL AEROLIZER for the treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use FORADIL AEROLIZER only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue FORADIL AEROLIZER) 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 FORADIL AEROLIZER for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
Pediatric and Adolescent Patients
Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be considered to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g. inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.
|
| |
FORADIL SUMMARY
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.
Each clear, hard gelatin capsule contains a dry powder blend of 12 mcg of formoterol fumarate and 25 mg of lactose (which contains trace levels of milk proteins) as a carrier.
The active component of FORADIL is formoterol fumarate, a racemate. Formoterol fumarate is a selective beta2-adrenergic bronchodilator.
Asthma
FORADIL AEROLIZER is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma.
Long-acting beta2-adrenergic agonists (LABA), such as formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death (see WARNINGS). Use of FORADIL AEROLIZER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use FORADIL AEROLIZER only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue FORADIL AEROLIZER) 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 FORADIL AEROLIZER for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
Pediatric and Adolescent Patients
Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients (see WARNINGS). For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g. inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.
Exercise-Induced Bronchospasm
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. Use of FORADIL AEROLIZER as a single agent for the prevention of exercise-induced bronchospasm may be clinically indicated in patients who do not have persistent asthma. In patients with persistent asthma, use of FORADIL AEROLIZER for the prevention of exercise-induced bronchospasm may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.
Chronic Obstructive Pulmonary Disease
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.
|
|
NEWS HIGHLIGHTS
Published Studies Related to Foradil (Formoterol Inhalation)
Combined therapy with tiotropium and formoterol in chronic obstructive pulmonary
disease: effect on the 6-minute walk test. [2013]
Combined therapy with tiotropium and long-acting beta 2 agonists confers
additional improvement in symptoms, lung function and aspects of health-related
quality of life (QOL) compared with each drug alone in patients with COPD. However, the efficacy of combined therapy on walking distance, a surrogate
measure of daily functional activity and morbidity remains unclear.
Safety and Tolerability of High-Dose Budesonide/Formoterol via Turbuhaler(R) in Japanese Patients with Asthma: A Randomized, Double-Blind, Crossover, Active Comparator-Controlled, Phase III Study. [2012.01.01]
Background: The use of budesonide/formoterol as both maintenance and reliever therapy in asthma is recommended in many countries; however, there are limited data available for the Asian patient population. Objective: This study aimed to evaluate the short-term safety and tolerability of a fixed high-dose combination of the inhaled corticosteroid budesonide and the long-acting beta(2)-adrenoceptor agonist formoterol with that of the beta(2)-agonist terbutaline for acute symptom relief in Japanese adults with persistent asthma who were already receiving a combination of budesonide/formoterol maintenance therapy...
AZD9668, a neutrophil elastase inhibitor, plus ongoing budesonide/formoterol in
patients with COPD. [2012]
well tolerated at doses of 60 mg bid during Phase I/IIa development... CONCLUSIONS: Three months' treatment with AZD9668 did not improve lung function,
Budesonide/Formoterol Pressurized Metered-Dose Inhaler versus Budesonide: A Randomized Controlled Trial in Black Patients with Asthma. [2011.12.01]
Objective.In this population of black asthma patients, BUD/FM pMDI resulted in greater improvements in pulmonary function and asthma control versus BUD DPI, with similar safety profiles.
A comparison of budesonide/formoterol maintenance and reliever therapy versus conventional best practice in asthma management in Spain. [2011.10]
OBJECTIVE: To study the effectiveness and safety in a real-life setting of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy(R) (Symbicort SMART(R)), a simplified management approach with one inhaler, compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma... CONCLUSIONS: A simplified regimen using budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and lower drug costs.
Clinical Trials Related to Foradil (Formoterol Inhalation)
Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT) [Withdrawn]
The purpose of this study is to compare the effects of nebulized formoterol fumarate
(Perforomist) to dry-powder inhaler formoterol fumarate (Foradil). Perforomist is a
solution that is made into very fine spray (using a nebulizer) that is then breathed in over
10-15 minutes. Foradil is taken in a single quick, deep inhalation.
Study of Arformoterol Tartrate Inhalation Solution and Racemic Formoterol in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) [Completed]
The purpose of this study is to compare the blood levels of arformoterol tartrate inhalation
solution to racemic formoterol in male and female subjects with mild to moderate Chronic
Obstructive Pulmonary Disease (COPD).
A Dose Ranging Study of Arformoterol Given Once Daily Compared to Arformoterol Given Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD) [Completed]
A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol
(given once or twice a day) in subjects with COPD.
PT005 MDI Dose Ranging Versus Foradil Aerolizer Study [Completed]
The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI
compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic
obstructive pulmonary disease (COPD).
Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma [Completed]
The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol
fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to
moderate asthma.
This study will include a screening visit followed by a 4 month treatment period.
Reports of Suspected Foradil (Formoterol Inhalation) Side Effects
Dyspnoea (24),
Malaise (21),
Death (19),
Fatigue (16),
Asthma (8),
Pruritus (8),
Tachycardia (8),
Cough (7),
Blood Pressure Increased (7),
Urticaria (6), more >>
|
|
|
|
Page last updated: 2014-11-30
|
