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    Breo Ellipta

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    mohammad
    Breo Ellipta is a combination inhaler containing fluticasone furoate and vilanterol indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and to reduce COPD exacerbations in patients with exacerbation history. It should be taken once daily using the Ellipta inhaler. Common side effects include nasopharyngitis, upper respiratory tract infection, headache, and oral candidiasis. Both drugs in Breo Ellipta are metabolized in the liver by CYP3A4 enzymes and have drug interactions with CYP3A4 inhibitors and other drug classes.

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    Breo Ellipta

    Uploaded by

    mohammad
    196 views11 pages
    Breo Ellipta is a combination inhaler containing fluticasone furoate and vilanterol indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and to reduce COPD exacerbations in patients with exacerbation history. It should be taken once daily using the Ellipta inhaler. Common side effects include nasopharyngitis, upper respiratory tract infection, headache, and oral candidiasis. Both drugs in Breo Ellipta are metabolized in the liver by CYP3A4 enzymes and have drug interactions with CYP3A4 inhibitors and other drug classes.

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    Breo Ellipta

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    Breo Ellipta is a combination inhaler containing fluticasone furoate and vilanterol indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and to reduce COPD exacerbations in patients with exacerbation history. It should be taken once daily using the Ellipta inhaler. Common side effects include nasopharyngitis, upper respiratory tract infection, headache, and oral candidiasis. Both drugs in Breo Ellipta are metabolized in the liver by CYP3A4 enzymes and have drug interactions with CYP3A4 inhibitors and other drug classes.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    196 views11 pages

    Breo Ellipta

    Uploaded by

    mohammad
    Breo Ellipta is a combination inhaler containing fluticasone furoate and vilanterol indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and to reduce COPD exacerbations in patients with exacerbation history. It should be taken once daily using the Ellipta inhaler. Common side effects include nasopharyngitis, upper respiratory tract infection, headache, and oral candidiasis. Both drugs in Breo Ellipta are metabolized in the liver by CYP3A4 enzymes and have drug interactions with CYP3A4 inhibitors and other drug classes.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 11

    Breo Ellipta

    Supervised by
    Dr. Adham Abu Taha
    Prepared by
    Mohammad Al-Shouli

    Trade name : Breo Ellipta


    Generic name : (fluticasone furoate and vilanterol
    inhalation powder)

    Company: GlaxoSmithKline
    Approval Status: Approved May 2013
    Treatment Area: chronic obstructive pulmonary
    disease

    About COPD
    Chronic obstructive pulmonary
    disease (COPD) is a term
    referring to two lung diseases
    1. chronic bronchitis
    2. and emphysema,
    characterised by obstruction
    to airflow that interferes with
    normal breathing

    Mechanism of Action
    a combination of
    1. fluticasone furoate, an inhaled corticosteroid (ICS)
    2. and vilanterol, a long-acting beta2-adrenergic agonist
    (LABA).

    Indications
    BreoEllipta is
    1. the only drug specifically indicated for the long-term, oncedaily, maintenance treatment of airflow obstruction in patients
    with chronic obstructive pulmonary disease (COPD), including
    chronic bronchitis and/or emphysema.
    2. Breo Ellipta is also indicated to reduce exacerbations of
    COPD in patients with a history of exacerbations.
    Important Limitations of Use:
    BREO ELLIPTA is NOT indicated for the relief of acute
    bronchospasm or for the treatment of asthma.

    WARNING: ASTHMA-RELATED DEATH


    placebo-controlled, trial comparing the safety of LABA (salmeterol) with placebo, each added to usual
    asthma therapy, showed an increase in asthma-related
    deaths in subjects receiving salmeterol

    increased risk of asthma-related death is considered a class effect of LABA, including


    vilanterol, one of the active ingredients in BREO ELLIPTA.
    No study adequate to determine whether the rate of asthma-related death is increased in
    subjects treated with BREO ELLIPTA has been conducted.
    The safety and efficacy of BREO ELLIPTA in patients with asthma have not been established. BREO
    ELLIPTA is not indicated for the treatment of asthma.

    DOSAGE AND ADMINISTRATION


    Breo Ellipta is supplied as a powder for inhalation.
    The recommended dose is 100 mcg fluticasone
    furoate /25 mcg vilanterol administered as 1
    inhalation once daily by the orally inhaled route only.
    After inhalation, the patient should rinse his/her mouth
    with water without swallowing to help reduce the risk of
    oropharyngeal candidiasis.
    Breo Ellipta should be taken at the same time every
    day.
    Do not use more than 1 time every 24 hours.

    Side Effects
    may include, but are not limited to, the following:
    1.
    2.
    3.
    4.

    Nasopharyngitis (common cold)


    upper respiratory tract infection
    headache
    oral candidiasis

    Pharmacokinetics
    plasma concentrations was achieved after 6 days, and the

    Absorption
    Distribution ( after IV )
    Metabolism
    Elimination

    fluticasone furoate

    vilanterol

    15.2%

    27.3%

    661 L
    hepatic metabolism via CYP3A4
    primarily in the feces 99 %
    Urine 1%

    165 L
    hepatic metabolism via CYP3A4
    Feces 30%
    Urine 70%

    Important safety information

    1. Contraindicated in patients with severe


    hypersensitivity to milk proteins or who have
    demonstrated hypersensitivity to either fluticasone
    furoate, vilanterol, or any of the excipients

    2. Inhaled medicines can produce paradoxical


    bronchospasm

    DRUG INTERACTIONS
    1. Strong CYP450 3A4 inhibitors (e.g., ketoconazole):
    May cause systemic cardiovascular effects.
    2. MAOIs and tricyclic antidepressants:
    May potentiate effect of vilanterol on vascular system.
    3. Beta-blockers:
    May block bronchodilatory effects of beta-agonists and
    produce severe bronchospasm.

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