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Tudorza Pressair

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Tudorza Pressair

INDICATIONS

TUDORZA™ PRESSAIR™ (aclidinium bromide inhalation powder) is indicated for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Dosage Forms and Strengths

Inhalation Powder. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide per actuation. Each actuation delivers 375 mcg of aclidinium bromide from the mouthpiece.

TUDORZA™ PRESSAIR™ (aclidinium bromide inhalation powder) 400 mcg is supplied in a sealed labeled aluminum pouch and is available in 60 metered doses (NDC 0456-0800-60).

The active ingredient is administered using a multi-dose dry powder inhaler, PRESSAIR™, which delivers 60 doses of aclidinium bromide powder for oral inhalation. The PRESSAIR inhaler is a white and green colored device and is comprised of an assembled plastic dosing mechanism with a dose indicator, a drug-product storage unit containing the drug-product formulation, and a mouthpiece covered by a green protective cap. The inhaler should be discarded when the marking "0" with a red background shows in the middle of the dose indicator or when the device locks out, whichever comes first.

Storage and Handling

Store TUDORZA PRESSAIR in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

The PRESSAIR inhaler should be stored inside the sealed pouch and only be opened immediately before use.

Discard the PRESSAIR inhaler 45 days after opening the pouch, after the marking "0" with a red background shows in the middle of the dose indicator, or when the device locks out, whichever comes first.

Keep out of reach of children.

Distributed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045. Revised: 07/2012

Last reviewed on RxList: 8/6/2012
This monograph has been modified to include the generic and brand name in many instances.

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Additional Tudorza Pressair Information

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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