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Indacaterol and mometasone inhalation


Inhalation powder capsules containing indacaterol acetate and mometasone furoate.

Drugs List

  • ATECTURA BREEZHALER 125microgram+127.5microgram inhalation powder capsules with device
  • ATECTURA BREEZHALER 125microgram+260microgram inhalation powder capsules with device
  • ATECTURA BREEZHALER 125microgram+62.5microgram inhalation powder capsules with device
  • indacaterol 125microgram and mometasone 127.5microgram inhalation powder capsules with device
  • indacaterol 125microgram and mometasone 260microgram inhalation powder capsules with device
  • indacaterol 125microgram and mometasone 62.5microgram inhalation powder capsules with device
  • Therapeutic Indications


    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.



    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 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.


    Children under 12 years
    Long QT syndrome
    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
    Ischaemic heart disease
    Lactose intolerance
    Myocardial infarction
    New York Heart Association class III failure
    Pulmonary tuberculosis

    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


    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.


    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
    Blurred vision
    Central serous chorioretinopathy
    Cushing's syndrome
    Cushingoid facies
    Decrease in bone mineral density
    Exacerbation of pre-existing asthma
    Hypersensitivity reactions
    Muscle spasm
    Musculoskeletal pain
    Oropharyngeal pain
    Psychomotor hyperactivity
    Sleep disorders
    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:
    Indacaterol Last revised: 03 December 2018
    Mometasone Last revised: 20 April 2020
    Last accessed: 24 February 2021.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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