IMPORTANT SAFETY INFORMATION
- TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is contraindicated in patients with severe hypersensitivity to milk proteins or who have hypersensitivity to aclidinium bromide or any of the excipients
- TUDORZA PRESSAIR is not indicated for the initial treatment of acute episodes of bronchospasm (ie, rescue therapy)
- Immediate hypersensitivity reactions, including anaphylaxis, angioedema (swelling of lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have occurred after administration of TUDORZA PRESSAIR. Additionally, inhaled medicines, including TUDORZA PRESSAIR, may cause paradoxical bronchospasm. If any of these occurs, treatment with TUDORZA PRESSAIR should be stopped and other treatments considered
- TUDORZA PRESSAIR should be used with caution in patients with 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 greater than placebo) were headache (6.6% vs 5.0%), nasopharyngitis (5.5% vs 3.9%), and cough (3.0% vs 2.2%), for TUDORZA PRESSAIR vs placebo, respectively
INDICATIONS AND USAGE
TUDORZA PRESSAIR is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Please also see the full Prescribing Information.