Chronic Obstructive Pulmonary Disease
Duaklir Pressair (aclidinium bromide and formoterol fumarate) is a long-acting muscarinic antagonist (LAMA) and long-acting beta2 agonist (LABA) fixed dose combination maintenance bronchodilator for the treatment of COPD. DUAKLIR PRESSAIR 400 mcg/12 mcg (aclidinium bromide and formoterol fumarate inhalation powder) is supplied in a sealed bag with a desiccant sachet and is available in 60 metered doses (NDC 72124-001-01) and 30 metered doses (NDC 72124-001-02).
The active ingredients are administered using a multi-dose dry powder inhaler, PRESSAIR�, which delivers 60 doses or 30 doses of aclidinium bromide and formoterol fumarate powder for oral inhalation. The PRESSAIR inhaler is a white and orange colored device and is comprised of an assembled plastic dosing mechanism with a dose indicator, a drug-product storage unit containing the drug-product formulation, and a mouthpiece covered by an orange protective cap.
Store DUAKLIR PRESSAIR in a dry place at 20�C-25�C (68�F-77�F); excursions permitted to 15-30�C (59-86�F) [see USP Controlled Room Temperature]. Do not store the inhaler on a vibrating surface.
The PRESSAIR inhaler should be stored inside the sealed bag and only be opened immediately before use. Throw away the bag and the desiccant sachet.
Throw away (dispose of) the PRESSAIR inhaler after the marking �0" with a red background shows in the middle of the dose indicator, when the device is empty and locks out, or 2 months after the date you opened the sealed bag that the inhaler comes in, whichever comes first.
Keep out of reach of children. These highlights do not include all the information needed to use DUAKLIR PRESSAIR safely and effectively. See full prescribing information for DUAKLIR PRESSAIR.
DUAKLIR� PRESSAIR� (aclidinium bromide and formoterol fumarate) inhalation powder, for oral inhalation
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
DUAKLIR PRESSAIR is a combination of aclidinium bromide an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1)
Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. (1,5.4).
DOSAGE AND ADMINISTRATION
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For oral inhalation only. (2)
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400 mcg/12 mcg, twice daily (once in the morning and once in the evening). (2)
DOSAGE FORMS AND STRENGTHS
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Inhalation Powder. (3)
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Breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide and 12 mcg of formoterol fumarate per actuation. (3)
CONTRAINDICATIONS
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Use of a long-acting beta2-adrenergic agonist (LABA), including formoterol fumarate, one of the active ingredients in DUAKLIR PRESSAIR, without an inhaled corticosteroid is contraindicated in patients with asthma. (1,4)
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Hypersensitivity to aclidinium bromide or formoterol fumarate or to any component of this product. (4,5.5)
WARNINGS AND PRECAUTIONS
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Asthma-related death: Long-acting beta2-adrenergic agonists as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of serious asthma-related events. (5.1)
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Do not initiate in acutely deteriorating COPD or to treat acute symptoms. (5.2)
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Do not use in combination with an additional medicine containing a LABA because of risk of overdose. (5.3)
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If paradoxical bronchospasm occurs, discontinue DUAKLIR PRESSAIR and institute alternative therapy. (5.4)
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Use with caution in patients with cardiovascular disorders. (5.6)
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Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus and ketoacidosis. (5.7)
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Be alert to hypokalemia and hyperglycemia. (5.8)
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Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a physician immediately if symptoms occur. (5.9)
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Worsening urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if symptoms occur. (5.10)
ADVERSE REACTIONS
Most common adverse reactions (incidence ? 3% and more common than with placebo) include: upper respiratory tract infection, headache and, back pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Use of other adrenergic by any route may potentiate the effect of DUAKLIR PRESSAIR. Use with caution. (5.3,7.1)
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Xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. (7.2,7.3)
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Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non-potassium sparing diuretics may worsen with concomitant beta2-agonists. (7.3)
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Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system. (7.4)
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Beta-blockers: Use with caution and only when medically necessary. (7.5)
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Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations of DUAKLIR PRESSAIR with other anticholinergic-containing drugs. (7.6)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 3/2019
