Indacaterol and mometasone inhalation
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Inhalation powder capsules containing indacaterol acetate and mometasone furoate.
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 and children over 12 years of age.
Dosage
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.
Children
Children aged 12 years of age and older
See Dosage; Adult
Additional Dosage Information
If a dose is missed, it should be taken as soon as possible on the same day.
Contraindications
Children under 12 years
Breastfeeding
Galactosaemia
Labour
Long QT syndrome
Pregnancy
Severe hepatic impairment
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
Epileptic disorder
Glucose-galactose malabsorption syndrome
History of long QT syndrome
History of torsade de pointes
Hypertension
Hypoxia
Ischaemic heart disease
Lactose intolerance
Myocardial infarction
New York Heart Association class III failure
Pulmonary tuberculosis
Thyrotoxicosis
Correct electrolyte disorders before treatment
Not suitable for acute treatment of asthma
Patients with diabetes may experience fluctuations in blood glucose
Contains lactose
Check patient is using correct inhaler technique
Consider monitoring ECG in patients at risk of QT prolongation
Diabetic control may need adjustment
If visual disturbances occur, perform ophthalmic evaluation
Monitor blood glucose closely in patients with diabetes mellitus
Monitor serum electrolytes
Advise patient to report any blurred vision or any other eye symptoms
Advise pt to seek medical attention if diff. swallowing or breathing occurs
May reduce serum potassium levels
Systemic effects possible with any inhaled corticosteroid
May cause changes to ECG
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 with mometasone is contraindicated during pregnancy.
The manufacturer does not recommend the use of indacaterol with mometasone during pregnancy, and states that indacaterol with mometasone 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 with mometasone during pregnancy. Potential risks are unknown.
Indacaterol may inhibit labour by effecting uterine contractility. It is unknown if indacaterol 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 with mometasone is contraindicated during breastfeeding.
The manufacturer does not recommend the use of indacaterol with mometasone during breastfeeding, and states that a decision must be made whether to discontinue indacaterol with mometasone, or to discontinue breastfeeding.
The presence of indacaterol with mometasone in human breast milk is unknown. Effects on exposed infants are unknown.
Side Effects
Adrenal suppression
Aggression
Angioedema
Anxiety
Blurred vision
Candidiasis
Cataracts
Central serous chorioretinopathy
Cushing's syndrome
Cushingoid facies
Decrease in bone mineral density
Depression
Dysphonia
Exacerbation of pre-existing asthma
Glaucoma
Headache
Hyperglycaemia
Hypersensitivity reactions
Muscle spasm
Musculoskeletal pain
Nasopharyngitis
Oropharyngeal pain
Pruritus
Psychomotor hyperactivity
Rash
Sleep disorders
Tachycardia
Upper respiratory tract infection
Visual disturbances
Further Information
Last Full Review Date: 24 February 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: Atectura Breezhaler. Novartis Pharmaceuticals UK Ltd. Revised May 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.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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