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Glycopyrronium and formoterol inhalation

Presentation

Inhalation formulation of glycopyrronium and formoterol.

Drugs List

  • BEVESPI AEROSPHERE 7.2microgram+5microgram pressurised inhaler
  • glycopyrronium and formoterol 7.2microgram + 5microgram/ dose inhaler cfc-free
  • Therapeutic Indications

    Uses

    Chronic obstructive pulmonary disease

    Maintenance treatment of symptomatic relief of chronic obstructive pulmonary disease in adults.

    Dosage

    Adults

    Two inhalations twice daily (two inhalations in the morning, and two inhalations in the evening), using the inhalation device provided.

    Additional Dosage Information

    If a dose is missed, the dose should be taken as soon as possible, and the next dose should be taken at the usual time. A double dose should not be taken in order to make up a missed dose.

    Contraindications

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

    Precautions and Warnings

    Family history of long QT syndrome
    Benign prostatic hyperplasia
    Diabetes mellitus
    Electrolyte imbalance
    End stage renal disease
    History of torsade de pointes
    Hypoxia
    Ischaemic heart disease
    Narrow angle glaucoma
    Severe cardiac failure
    Severe cardiovascular disorder
    Severe hepatic impairment
    Severe renal impairment
    Tachyarrhythmia
    Thyrotoxicosis
    Urinary retention

    Correct electrolyte disorders before treatment
    Not suitable for acute treatment of bronchospasm
    Advise ability to drive/operate machinery may be affected by side effects
    Check patient is using correct inhaler technique
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor patients with hepatic impairment for adverse effects
    Monitor serum electrolytes
    Discontinue if paradoxical bronchospasm occurs

    Glycopyrronium and formoterol should not be used in patients with severe renal impairment or end-stage renal disease requiring dialysis unless the expected benefit outweighs the potential risk.

    Pregnancy and Lactation

    Pregnancy

    Glycopyrronium and formoterol is contraindicated during pregnancy.

    The manufacturer advises caution if glycopyrronium and formoterol is used during pregnancy, and states that glycopyrronium and formoterol 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 glycopyrronium and formoterol during pregnancy. Potential risks are unknown.

    Glycopyrronium has been shown to cross the human placenta.

    It is unknown if formoterol crosses the human placenta.

    Lactation

    Glycopyrronium and formoterol is contraindicated during breastfeeding.

    The manufacturer advises caution if glycopyrronium and formoterol is used during breastfeeding, and states that a decision must be made whether to discontinue glycopyrronium and formoterol, or to discontinue breastfeeding.

    The presence of glycopyrronium and formoterol in human breast milk is unknown. Effects on exposed infants are unknown. LactMed (2018) states that the use of inhaled bronchodilators during breastfeeding is acceptable due to the predicted low bioavailability and maternal serum levels.

    Side Effects

    Agitation
    Anxiety
    Atrial fibrillation
    Cardiac arrhythmias
    Chest pain
    Dizziness
    Dry mouth
    Extrasystoles
    Headache
    Hyperglycaemia
    Hypersensitivity reactions
    Insomnia
    Muscle spasm
    Nausea
    Palpitations
    Pruritus
    Rash
    Restlessness
    Supraventricular arrhythmias
    Tachycardia
    Tremor
    Urinary retention
    Urinary tract infections

    Further Information

    Last Full Review Date: March 2021

    Reference Sources

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 March 2021.

    Summary of Product Characteristics: Bevespi Aerosphere 7.2micrograms/5micrograms pressurised inhalation suspension. AztraZeneca UK Limited. Revised September 2020.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
    Formoterol Last revised: 31 October 2018.
    Last accessed: 17 March 2021.

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