Classes
DEA Class; Rx
Common Brand Names; Utibron Neohaler
- Anticholinergics, Respiratory;
- Beta2 Agonists;
- Respiratory Inhalant Combos;
- COPD Agents
Description
Inhaled combination of a long-acting beta-2 adrenergic agonist (LABA), (indacaterol) and a long-acting muscarinic antagonist (LAMA), (glycopyrrolate)
Used in adults for the treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Not indicated for the treatment of acute bronchospasm and is not to be used 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
All LABAs are contraindicated in patients with asthma without use of an inhaled corticosteroid; indacaterol/glycopyrrolate is not indicated for the treatment of asthma
Adverse Effects
- Cough (4%)
- Urinary tract infection (2.6%)
- Arthralgia (<2%)
- Chest pain (<2%)
- Tooth abscess (<2%)
- Muscle spasms (<2%)
- Headache (<2%)
- Oropharyngeal pain (<2%)
- Vomiting (<2%)
- Pain in extremity (<2%)
- Dizziness (<2%)
- Anxiety (<2%)
- Dry mouth (<2%)
- Fall (<2%)
- Influenza (<2%)
- Fatigue (<2%)
- Acute sinusitis (<2%)
- Contusion (<2%)
Warnings
Safety and efficacy in patients with asthma not established; not indicated for asthma; monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death (see Black Box Warnings)
Available data do not suggest an increased risk of death with use of LABA in patients with COPD
Should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD; also do not use for the relief of acute symptoms (ie, as rescue therapy) for treating acute episodes of bronchospasm
Do not use more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABAs, as an overdose may result; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs; patients receiving therapy should not use another medicine containing a LABA for any reason
Can produce paradoxical bronchospasm that may be life-threatening Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrrolate; if signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of tongue, lips, and face), anaphylaxis, urticaria, or skin rash, therapy should be discontinued immediately and alternative therapy instituted; drug should be used with caution in patients with severe hypersensitivity to milk proteins
Pregnancy and Lactation
There are no adequate and well-controlled studies with drug combination or its individual components, indacaterol and glycopyrrolate, in pregnant women; women should be advised to contact their healthcare provider if they become pregnant while receiving therapy
There is no data on presence of indacaterol or glycopyrrolate or their metabolites in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
Contents of 2 capsules/day (total of 55 mcg indacaterol and 31.2 mcg glycopyrrolate) by inhalation.
Contents of 2 capsules/day (total of 55 mcg indacaterol and 31.2 mcg glycopyrrolate) by inhalation.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
