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Arcapta Neohaler (Indacaterol Maleate) - Summary

 
 



WARNING: ASTHMA-RELATED DEATH

L ong-acting beta 2 -adrenergic agonist s   (LABA) increase the risk of asthma-related death.   Data from a large placebo-controlled US study that compared the safety of another long-acting beta 2 -adrenergic agonist (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 indacaterol, the active ingredient in ARCAPTA NEOHALER . The safety and efficacy of ARCAPTA NEOHALER in patients with asthma have not been established. A RCAPTA NEOHALER is not indicated for the treatment of asthma. [See C ontraindications (4),   W arnings and Precautions   (5.1) ] .

 

SUMMARY

ARCAPTA NEOHALER consists of a dry powder formulation of indacaterol maleate for oral inhalation only with the NEOHALER inhaler. The inhalation powder is packaged in clear gelatin capsules. Each clear, hard gelatin capsule contains a dry powder blend of 75 mcg of indacaterol (equivalent to 97 mcg of indacaterol maleate) with approximately 25 mg of lactose monohydrate (which contains trace levels of milk protein) as the carrier. The active component of ARCAPTA NEOHALER is indacaterol maleate, a (R) enantiomer. Indacaterol maleate is a selective beta2-adrenergic agonist.

Maintenance Treatment of COPD

ARCAPTA NEOHALER is a long-acting beta2-agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 

Important Limitations of Use

ARCAPTA NEOHALER is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see Warnings and Precautions].

ARCAPTA NEOHALER is not indicated to treat asthma. The safety and effectiveness of ARCAPTA NEOHALER in asthma have not been established.


See all Arcapta Neohaler indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Arcapta Neohaler (Indacaterol)

Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. [2011]
BACKGROUND: Indacaterol is an inhaled, once-daily long-acting beta(2)-agonist bronchodilator for regular use in patients with chronic obstructive pulmonary disease (COPD). As indacaterol is the first once-daily beta(2)-agonist to be developed, it is relevant to evaluate its bronchodilator efficacy, safety, and tolerability... CONCLUSION: Indacaterol was an effective bronchodilator and was well tolerated, with a good safety profile over 12 weeks of treatment. It should prove a useful treatment for patients with moderate-to-severe COPD.

Bronchodilator efficacy of single doses of indacaterol in Japanese patients with COPD: A randomised, double-blind, placebo-controlled trial. [2010]
and safety of indacaterol in Japanese patients with COPD... CONCLUSIONS: In the Japanese COPD population studied, single doses of indacaterol

Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. [2010]
twice-daily LABA formoterol and placebo over 1 year... CONCLUSIONS: Once-daily indacaterol is an effective 24 h bronchodilator that

Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design. [2010]
COPD (chronic obstructive pulmonary disease)... CONCLUSION: The adaptive seamless design is a novel and efficient way to combine

24-hour bronchodilator efficacy of single doses of indacaterol in patients with persistent asthma: comparison with placebo and formoterol. [2009]
indacaterol in asthma... CONCLUSIONS: Single doses of indacaterol provided effective 24-h bronchodilation

more studies >>


Page last updated: 2013-02-10

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