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Mometasone Inhaled/Formoterol

    Brands

    DEA Class;  Rx

    Common Brand Names; Dulera

    • Respiratory Inhalant Combos

    Orally inhaled combination of a corticosteroid (ICS, mometasone) and long-acting beta-2 agonist (LABA, formoterol)
    Used for maintenance treatment of asthma in adult and pediatric patients 5 years and older
    Used off-label for maintenance treatment of COPD in adults

    Indicated for asthma maintenance treatment.
    For the maintenance treatment of chronic obstructive pulmonary disease (COPD) (e.g., chronic bronchitis or emphysema).

    Hypersensitivity

    Primary treatment for acute bronchospasm, status asthmaticus, or exercise-induced bronchospasm

    • Nasopharyngitis (4.7%)
    • Headache (2-4.5%)
    • Sinusitis (2-3.3%)
    • Oral candidiasis
    • Cardiac: Angina pectoris, cardiac arrhythmias (eg, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), QT prolongation, elevated blood pressure (including hypertension)
    • Metabolic, nutritional: Hypokalemia, hyperglycemia
    • Respiratory, thoracic, mediastinal: Asthma aggravation (potentially including cough, dyspnea, wheezing, bronchospasm)
    • Vision blurred

    Use of LABAs as monotherapy (without inhaled corticosteroids) for asthma is associated with an increased risk of asthma-related death

    Data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patient

    Localized infections of the mouth and pharynx with Candida albicans reported; if oropharyngeal candidiasis develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment; at times therapy may need to be interrupted

    To reduce risk of oropharyngeal candidiasis, after dosing, advise patients to rinse their mouth with water and spit out the contents without swallowing

    Pregnancy: There are no randomized clinical studies in pregnant women; there are clinical considerations with use in pregnant women In women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate

    Lactation: There are no available data on the presence of mometasone furoate, or formoterol fumarate in human milk; the effects on the breastfed child, or the effects on milk production

    Adults

    800 mcg of mometasone and 20 mcg of formoterol via oral inhalation/day; the maximum number of inhalations = 4/day regardless of product strength.

    Geriatric

    800 mcg of mometasone and 20 mcg of formoterol via oral inhalation/day; the maximum number of inhalations = 4/day regardless of product strength.

    Adolescents

    800 mcg of mometasone and 20 mcg of formoterol via oral inhalation/day; the maximum number of inhalations = 4/day regardless of product strength.

    Children

    12 years: 800 mcg of mometasone and 20 mcg of formoterol via oral inhalation/day; the maximum number of inhalations = 4/day regardless of product strength.
    5 to 11 years: 200 mcg of mometasone and 20 mcg of formoterol via oral inhalation/day; the maximum number of inhalations = 4/day.
    1 to 4 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Formoterol fumarate

    Mometasone/formoterol

    aerosol

    • (50mcg/5mcg)/actuation
    • (100mcg/5mcg)/actuation
    • (200mcg/5mcg)/actuation