Indication and Usage
DUAKLIR PRESSAIR (aclidinium bromide/formoterol fumarate inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Important Safety Information
- DUAKLIR PRESSAIR (aclidinium bromide/formoterol fumarate inhalation powder) is only indicated for use in COPD and is not indicated for use in asthma. Use of a long-acting beta2-adrenergic agonist (LABA) as monotherapy, including formoterol fumarate, one of the active ingredients in DUAKLIR PRESSAIR, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma and increases the risk of asthma-related death. When LABA are used in fixed-dose combinations with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone.
- DUAKLIR PRESSAIR is contraindicated in patients with severe hypersensitivity to milk proteins or who have hypersensitivity to aclidinium bromide or formoterol fumarate or any component of the product
- DUAKLIR PRESSAIR is not indicated for the treatment of acute episodes of bronchospasm (i.e. rescue therapy)
- Do not initiate DUAKLIR PRESSAIR with an additional medicine containing a LABA because of risk of overdose or in acutely deteriorating COPD
- Immediate hypersensitivity reactions, including anaphylaxis, angioedema (swelling of lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have occurred after administration of DUAKLIR PRESSAIR. Additionally, inhaled medicines, including DUAKLIR PRESSAIR, may cause paradoxical bronchospasm which may be life threatening. If any of these occurs, immediate treatment with a short acting bronchodilator should be initiated and treatment with DUAKLIR PRESSAIR should be stopped and alternative therapy initiated
- DUAKLIR PRESSAIR should be used with caution in patients with cardiovascular and convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, hypokalemia, hyperglycemia, narrow-angle glaucoma or urinary retention. Instruct patients to consult a physician immediately should any signs or symptoms of acute narrow-angle glaucoma or prostatic hyperplasia or bladder-neck obstruction develop
- The most common adverse reactions (≥3% incidence and more common than placebo) were upper respiratory tract infection (8.9% vs 6.3%), headache (6.3% vs 5.1%), and back pain (3.8% vs 3.4%) for DUAKLIR PRESSAIR vs placebo, respectively. Other adverse reactions reported in clinical studies (>1% but less than 3% and more common than placebo) with DUAKLIR PRESSAIR were cough, sinusitis, influenza, tooth abscess, insomnia, dizziness, dry mouth, oropharyngeal pain, muscle spasm, musculoskeletal pain, arthralgia, pain in extremity, urinary tract infection, and increased blood creatine phosphokinase
For answers to your medical questions about DUAKLIR PRESSAIR, please contact Circassia Medical Information at firstname.lastname@example.org.
Please also see the full Prescribing Information, including Patient Information.