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Indacaterol, inhaled

    Brands

    DEA Class;  Rx

    Common Brand Names; Arcapta Neohaler

    • Beta2 Agonists

    Inhaled long-acting beta-2 adrenergic agonist (LABA); given once-daily
    Used for the maintenance treatment of COPD in adults
    Not indicated for the relief of acute bronchospasm or for the treatment of asthma

    Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) (e.g., chronic bronchitis or emphysema).

    Hypersensitivity

    Use of a long-acting beta2-adrenergic agonists (LABAs) without an inhaled corticosteroid in patients with asthma

    • Post-inhalation cough (24% compared with 7% on placebo)
    • Cough (6.5%)
    • Nasopharyngitis (5.3%)
    • Headache (5.1%)
    • Nausea (2.4%)
    • Oropharyngeal pain (2.2%)

    Postmarketing Reports

    • Hypersensitivity reactions
    • Paradoxical bronchospasm
    • Tachycardia/heart rate increase/palpitations
    • Pruritus/rash
    • Dizziness
    • Pruritus

    Do not initiate in acutely deteriorating COPD patients

    Do not use for relief of acute symptoms; prescribe concomitant short-acting beta2-agonists for acute exacerbations

    Do not exceed recommended daily dose; excessive doses may result in cardiovascular effects and may be fatal

    Life-threatening paradoxical bronchospasm can occur; discontinue use immediately

    Immediate hypersensitivity reactions may occur after administration of therapy; if signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash, anaphylaxis) occur, discontinue therapy and institute alternative therapy

    Safety and efficacy in patients with asthma not established; not indicated for asthma

    Data from a large placebo-controlled study in asthma patients showed that long-acting beta2-adrenergic agonists may increase the risk of asthma-related death (see Black Box Warnings)

    Caution with CV disease, epilepsy, thyrotoxicosis, or sensitivity to sympathomimetics

    Contains trace levels of milk protein.

    There are no adequate and well-controlled studies in pregnant women; women should be advised to contact their physician if they become pregnant while receiving therapy

    There is no data on presence of indacaterol in human milk, effect on breastfed infant, or on milk production

    Adults

    75 mcg/day by inhalation.

    Geriatric

    75 mcg/day by inhalation.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Indacaterol, inhaled

    capsule, powder for inhalation

    • 75mcg/capsule