Dosing and administration

The recommended dose of TUDORZA PRESSAIR is one oral inhalation of 400 mcg, twice daily1

  • 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 probable1

TUDORZA PRESSAIR prescription

Dose Delivery

  • 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

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INDICATIONS AND USAGE

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.

Please also see the full Prescribing Information.