"The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease ("...
DOSAGE AND ADMINISTRATION
The recommended dose of TUDORZA PRESSAIR is one oral inhalation of 400 mcg, twice daily.
Dosage Forms And Strengths
TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide per actuation.
TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) 400 mcg is supplied in a sealed labeled aluminum pouch and is available in 60 metered doses (NDC 0310-0800-60) and 30 metered doses (NDC 0310-0800-39).
The active ingredient is administered using a multi-dose dry powder inhaler, PRESSAIR®, which delivers 60 doses or 30 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: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 Under license of ALMIRALL, S.A. Revised: Mar 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/29/2016
Additional Tudorza Pressair Information
- Tudorza Pressair Drug Interactions Center: aclidinium bromide inhl
- Tudorza Pressair Side Effects Center
- Tudorza Pressair FDA Approved Prescribing Information including Dosage
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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