Indacaterol and mometasone and glycopyrronium inhalation
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Inhalation powder capsules containing indacaterol acetate, mometasone furoate and glycopyrronium bromide.
Maintenance treatment of asthma which is not adequately controlled with inhaled corticosteroids and inhaled short-acting beta-2-agonists in adults.
Inhalation of one capsule once daily (at the same time of day) using the inhalation device provided. Patients should be advised not to take more than one dose in a day.
Additional Dosage Information
If a dose is missed, it should be taken as soon as possible on the same day.
Children under 18 years
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Uncontrolled systemic infection
End stage renal disease
Glucose-galactose malabsorption syndrome
History of seizures
History of torsade de pointes
Ischaemic heart disease
Narrow angle glaucoma
New York Heart Association class III failure
Severe hepatic impairment
Severe renal impairment
Correct electrolyte disorders before treatment
Not suitable for acute treatment of asthma
Check patient is using correct inhaler technique
Consider monitoring ECG in patients at risk of QT prolongation
If visual disturbances occur, perform ophthalmic evaluation
Monitor blood glucose closely in patients with diabetes mellitus
Monitor serum electrolytes
Advise pt to seek medical attention if diff. swallowing or breathing occurs
May reduce serum potassium levels
Systemic effects possible with any inhaled corticosteroid
Avoid abrupt withdrawal
Discontinue if allergic reaction occurs
Discontinue if paradoxical bronchospasm occurs
Maintain treatment at the lowest effective dose
Advise patient not to exceed stated dose
Advise patient not to use for relief of acute attacks
Advise patient to rinse mouth with water after each inhaled dose
Advise patient to seek medical advice if treatment is ineffective
Pregnancy and Lactation
Indacaterol and mometasone and glycopyrronium is contraindicated during pregnancy.
The manufacturer does not recommend the use of indacaterol and mometasone and glycopyrronium during pregnancy, and states that indacaterol and mometasone and glycopyrronium should only be used during pregnancy if the potential benefits outweigh the potential risks.
At the time of writing there is limited published information regarding the use of indacaterol and mometasone and glycopyrronium during pregnancy. Potential risks are unknown.
Indacaterol may inhibit labour by effecting uterine contractility. It is unknown if indacaterol crosses the human placenta.
It is unknown if glycopyrronium crosses the human placenta.
Animal studies have shown developmental toxicity with mometasone (Briggs, 2015). It is unknown if mometasone crosses the human placenta.
Indacaterol and mometasone and glycopyrronium is contraindicated during breastfeeding.
The manufacturer does not recommend the use of indacaterol and mometasone and glycopyrronium during breastfeeding, and states that a decision must be made whether to discontinue indacaterol and mometasone and glycopyrronium, or to discontinue breastfeeding.
The presence of indacaterol and mometasone and glycopyrronium in human breast milk is unknown. Effects on exposed infants are unknown.
Exacerbation of pre-existing asthma
Upper respiratory tract infection
Urinary tract infections
Last Full Review Date: 11 March 2021
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Enerzair Breezhaler. Novartis Pharmaceuticals UK Ltd. Revised July 2020.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Indacaterol Last revised: 03 December 2018
Mometasone Last revised: 20 April 2020
Last accessed: 24 February 2021.
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