Tudorza Pressair powder

Tudorza Pressair powder is an anticholinergic for the long-term management of chronic obstructive pulmonary disease (COPD). It has a much higher propensity to bind to muscarinic receptors than nicotinic receptors. FDA approved on July 24, 2012.

Tudorza Pressair powder 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. (Chronic obstructive pulmonary disease;)

Tudorza Pressair powder is used to treat bronchospasm caused by chronic obstructive pulmonary disease (COPD). COPD is a lung disease that also includes chronic bronchitis (swelling of the tubes leading to the lungs) and emphysema (damage to the air sacs in the lungs).

Tudorza Pressair powder is a bronchodilator. Bronchodilators are breathed in through the mouth to help open up the bronchial tubes (air passages) in the lungs. It is taken by inhalation (an inhaler) and will increase the flow of air to the lungs.

Tudorza Pressair powder is available only with your doctor's prescription.

The recommended dose of Tudorza Pressair powder is one oral inhalation of 400 mcg, twice daily.

How supplied

Dosage Forms And Strengths

Inhalation Powder

Tudorza Pressair powder is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of Tudorza Pressair powder bromide per actuation.

TUDORZA® PRESSAIR® (Tudorza Pressair powder 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 Tudorza Pressair powder 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 powder in a dry place at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F).

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 2016

See also:
What is the most important information I should know about Tudorza Pressair powder?

​The use of Tudorza Pressair powder is contraindicated in the following conditions:

Use Tudorza Pressair powder powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet with detailed instructions for use is available with Tudorza Pressair powder powder. Talk to your pharmacist if you have questions about this information.
• When you are ready to use Tudorza Pressair powder powder for the first time, remove it from the pouch. To do so, tear along the "notch," remove the inhaler, and discard the pouch.
• Remove the protective cap from the inhaler. Look to see that nothing is blocking the mouthpiece. Hold the inhaler with the green button facing straight up and with the mouthpiece facing you but not inside your mouth. Before you put the inhaler in your mouth, press the green button all the way down, then release it. Check the control window to make sure that it has changed from red to green. A green control window means that your inhaler is ready to use. If the control window stays red, repeat the above steps until it changes to green.
• Before putting the inhaler in your mouth, breathe out completely. Do not breathe out into the inhaler. Put your lips tightly around the mouthpiece and breathe in quickly and deeply through your mouth. Continue breathing in until you hear a "click" sound. Keep breathing in, even after you have heard this sound, to get your full dose. Do not hold down the green button while you breathe in. Remove the inhaler from your mouth, hold your breath for as long as comfortable, then breathe out slowly through your nose.
• Make sure you have used the inhaler correctly. If the control window is red, you have used it correctly. If it is still green, repeat the inhalation process. Replace the protective cap onto the inhaler after you have used your dose.
• You may taste Tudorza Pressair powder powder while you inhale it. If you do not taste Tudorza Pressair powder powder, do not take an extra dose.
• If your inhaler appears to be damaged or if you lose the cap, replace your inhaler.
• You do not need to clean your inhaler. If you wish to clean it, wipe the outside of the mouthpiece with a dry tissue or paper towel. Do NOT use water to clean your inhaler; this may damage your medicine.
• Avoid contact with the eyes. Flush with water immediately if eye contact occurs. Blurring of vision, pupil dilation, worsening of narrow-angle glaucoma, or eye pain or discomfort may result if Tudorza Pressair powder powder comes into direct contact with the eyes. Contact your doctor if you notice these symptoms.
• This inhaler contains 60 doses. Throw away this inhaler after 60 doses have been used (when a "0" with a red background appears in the middle of the dose indicator on the inhaler or when the device locks) or 45 days after opening the pouch, whichever occurs first.
• If you miss a dose of Tudorza Pressair powder powder, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tudorza Pressair powder powder.

Use: Labeled Indications

Chronic obstructive pulmonary disease: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

See also:
What other drugs will affect Tudorza Pressair powder?

In vitro studies suggest limited potential for CYP450-related metabolic drug interactions, thus no formal drug interaction studies have been performed with Tudorza Pressair powder.

Sympathomimetics, Methylxanthines, Steroids

In clinical studies, concurrent administration of Tudorza Pressair powder bromide and other drugs commonly used in the treatment of COPD including sympathomimetics (short-acting beta2 agonists), methylxanthines, and oral and inhaled steroids showed no increases in adverse drug reactions.

Anticholinergics

There is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of Tudorza Pressair powder with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic effects.

See also:
What are the possible side effects of Tudorza Pressair powder?

The following adverse reactions are described in greater detail in other sections:

• Paradoxical bronchospasm
• Worsening of narrow-angle glaucoma
• Worsening of urinary retention
• Immediate hypersensitivity reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

3-Month And 6-Month Trials

Tudorza Pressair powder was studied in two 3-month (Trials B and C) and one 6-month (Trial D) placebo-controlled trials in patients with COPD. In these trials, 636 patients were treated with Tudorza Pressair powder at the recommended dose of 400 mcg twice daily.

The population had a mean age of 64 years (ranging from 40 to 89 years), with 58% males, 94% Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV) percent predicted of 48%. Patients with unstable cardiac disease, narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these trials.

Table 1 shows all adverse reactions that occurred with a frequency of greater than or equal to 1% in the Tudorza Pressair powder group in the two 3-month and one 6-month placebo-controlled trials where the rates in the Tudorza Pressair powder group exceeded placebo.

Table 1: Adverse Reactions (% Patients) in Placebo-Controlled Clinical Trials

In addition, among the adverse reactions observed in the clinical trials with an incidence of less than 1% were diabetes mellitus, dry mouth, 1 degree AV block, osteoarthritis, cardiac failure, and cardio-respiratory arrest.

Long-term Safety Trials

Tudorza Pressair powder was studied in three long term safety trials, two double blind and one open label, ranging from 40 to 52 weeks in patients with moderate to severe COPD. Two of these trials were extensions of the 3-month trials, and one was a dedicated long term safety trial. In these trials, 891 patients were treated with Tudorza Pressair powder at the recommended dose of 400 mcg twice daily. The demographic and baseline characteristics of the long term safety trials were similar to those of the placebo-controlled trials. The adverse events reported in the long term safety trials were similar to those occurring in the placebo-controlled trials of 3 to 6 months. No new safety findings were reported compared to the placebo controlled trials.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of drug Tudorza Pressair powder. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In postmarketing experience with Tudorza Pressair powder, immediate hypersensitivity reactions, including anaphylaxis, angioedema (including swelling of the lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have been reported. Additionally, nausea, dysphonia, blurred vision, urinary retention, tachycardia and stomatitis have been observed.