Important Safety Information
- TUDORZA PRESSAIR 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 prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any worsening of glaucoma or worsening of urinary retention 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. In a long-term cardiovascular safety trial of up to 3 years, the adverse reactions (occurring at a rate of ≥2% and more common than placebo) were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease
INDICATIONS AND USAGE
Tudorza® Pressair® (aclidinium bromide inhalation powder) is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
TUDORZA is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.
Please also see the full Prescribing Information, including Patient Information.
You are encouraged to report any TUDORZA adverse events by calling 1-833-614-9269. If you prefer to report these to the FDA, either visit www.fda.gov/medwatch or call 1-800-FDA-1088.