Classes
DEA Class; Rx
Common Brand Names; Arcapta Neohaler
- Beta2 Agonists
Description
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
Indications
Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) (e.g., chronic bronchitis or emphysema).
Contraindications
Hypersensitivity
Use of a long-acting beta2-adrenergic agonists (LABAs) without an inhaled corticosteroid in patients with asthma
Adverse Effects
- 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
Warnings
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.
Pregnancy and Lactation
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
Maximum Dosage
75 mcg/day by inhalation.
75 mcg/day by inhalation.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Indacaterol, inhaled
capsule, powder for inhalation
- 75mcg/capsule
