Drugs List

Therapeutic Indications

Uses

Asthma: Maintenance

Maintenance treatment of asthma which is not adequately controlled with inhaled corticosteroids and inhaled short-acting beta-2-agonists in adults.

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
Long QT syndrome
Pregnancy
Torsade de pointes

Precautions and Warnings

Chronic infection
Family history of long QT syndrome
Uncontrolled systemic infection
Cardiac arrhythmias
Cardiovascular disorder
Cerebrovascular disorder
Diabetes mellitus
Electrolyte imbalance
End stage renal disease
Glucose-galactose malabsorption syndrome
History of seizures
History of torsade de pointes
Hypertension
Ischaemic heart disease
Myocardial infarction
Narrow angle glaucoma
New York Heart Association class III failure
Pulmonary tuberculosis
Severe hepatic impairment
Severe renal impairment
Thyrotoxicosis
Urinary retention

Correct electrolyte disorders before treatment
Not suitable for acute treatment of asthma
Contains lactose
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

Pregnancy

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.

Lactation

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.

Side Effects

Candidiasis
Cataracts
Cough
Dry mouth
Dysphonia
Dysuria
Exacerbation of pre-existing asthma
Gastro-enteritis
Headache
Hyperglycaemia
Hypersensitivity reactions
Muscle spasm
Musculoskeletal pain
Nasopharyngitis
Oropharyngeal pain
Pruritus
Pyrexia
Rash
Tachycardia
Upper respiratory tract infection
Urinary tract infections

Presentation

Inhalation powder capsules containing indacaterol acetate, mometasone furoate and glycopyrronium bromide.

Drugs List

Therapeutic Indications

Uses

Asthma: Maintenance

Maintenance treatment of asthma which is not adequately controlled with inhaled corticosteroids and inhaled short-acting beta-2-agonists in adults.

Dosage

Adults

Additional Dosage Information

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
Long QT syndrome
Pregnancy
Torsade de pointes

Precautions and Warnings

Chronic infection
Family history of long QT syndrome
Uncontrolled systemic infection
Cardiac arrhythmias
Cardiovascular disorder
Cerebrovascular disorder
Diabetes mellitus
Electrolyte imbalance
End stage renal disease
Glucose-galactose malabsorption syndrome
History of seizures
History of torsade de pointes
Hypertension
Ischaemic heart disease
Myocardial infarction
Narrow angle glaucoma
New York Heart Association class III failure
Pulmonary tuberculosis
Severe hepatic impairment
Severe renal impairment
Thyrotoxicosis
Urinary retention

Correct electrolyte disorders before treatment
Not suitable for acute treatment of asthma
Contains lactose
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

Pregnancy

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.

Lactation

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.

Side Effects

Candidiasis
Cataracts
Cough
Dry mouth
Dysphonia
Dysuria
Exacerbation of pre-existing asthma
Gastro-enteritis
Headache
Hyperglycaemia
Hypersensitivity reactions
Muscle spasm
Musculoskeletal pain
Nasopharyngitis
Oropharyngeal pain
Pruritus
Pyrexia
Rash
Tachycardia
Upper respiratory tract infection
Urinary tract infections

Further Information

Last Full Review Date: 11 March 2021

Reference Sources

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.