Efficacy for TUDORZA was established in 3 confirmatory clinical trials.
TUDORZA PRESSAIR INHALER
A preloaded, multiple-dose, dry powder inhaler. See complete step-by-step Instructions for Use in the full Prescribing Information.
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Dosing and administration
The recommended dose of TUDORZA PRESSAIR is one oral inhalation of 400 mcg,
No dosage adjustment is necessary for older patients1
No dosage adjustment is needed for patients with impaired renal function1
TUDORZA PRESSAIR should be used during pregnancy and labor and delivery only if the potential benefit to the patient
justifies the potential risk to the fetus1
Caution should be exercised when TUDORZA PRESSAIR is administered to nursing women. Excretion in human milk is
The PRESSAIR inhaler delivers the target dose at flow rates as low as 35 L/min. Based on a study in patients with moderate
and severe COPD (n=24 for each), mean peak inspiratory flow rates were 95.3 L/min (54.6 L/min to 129.4 L/min)
and 88.7 L/min (72.0 L/min to 106.4 L/min), respectively1
On average, patients achieved 2 times the inspiratory flow needed to reliably inhale
the full dose
The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory
flow rate and inspiratory time
TUDORZA™ PRESSAIR™ (aclidinium bromide inhalation powder) is an anticholinergic indicated for the
long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD),
including chronic bronchitis and emphysema.
IMPORTANT SAFETY INFORMATION
TUDORZA PRESSAIR is not indicated for the initial treatment of acute episodes of bronchospasm (ie, rescue therapy).
Inhaled medicines, including TUDORZA, may cause paradoxical bronchospasm. In addition, immediate hypersensitivity reactions may occur after administration of TUDORZA. If either of these occurs, treatment with TUDORZA should be stopped and other treatments considered.
TUDORZA 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 narrow-angle glaucoma or prostatic hyperplasia or bladder-neck obstruction develop.
Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to TUDORZA. Use with caution in patients with severe hypersensitivity to milk proteins.
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 vs placebo, respectively.
call Forest Pharmaceuticals toll-free at 1-800-678-1605.
017-13000235 12/12TUDORZA™ and PRESSAIR™ are trademarks of ALMIRALL, S.A.
TUDORZA PRESSAIR (aclidinium bromide inhalation powder)
Prescribing Information. Forest Pharmaceuticals, Inc. St. Louis, MO.
Data on file. Forest Laboratories, Inc.
Kerwin EM, D’Urzo AD, Gelb AF, et al, on behalf of the ACCORD 1 study investigators.
Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in
COPD patients (ACCORD COPD I). COPD. 2012;9:90-101.
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