Tudorza Pressair

Tudorza Pressair Overview

Serious side effects have been reported with Tudorza Pressair including the following:

Sudden shortness of breath. Although rare, a sudden shortness of breath due to closing of the airways has been reported with medications similar to Tudorza Pressair. If this occurs, discontinue use immediately and get medical attention. Other treatments may need to be considered 

Worsening of glaucoma. If you have narrow-angle glaucoma, Tudorza Pressair may cause a worsening of symptoms.  This is a serious side effect that can lead to permanent loss of vision if not treated. Consult with your physician immediately if you experience any symptoms of worsening glaucoma. Symptoms of worsening acute narrow-angle glaucoma may include:

• eye pain 
• eye discomfort
• upset stomach or vomiting
• blurred vision
• seeing halos or bright colors around lights
• red eyes

Urinary retention (inability to urinate). This medication should be used with caution if you have existing urinary problems. Urinary retention can be caused by blockage in your bladder or, if you are a male, a larger than normal prostate. Symptoms of urinary retention may include:

• difficulty urinating
• painful urination
• urinating frequently
• urination in a weak stream or drips

If you experience any of these symptoms of urinary retention, stop taking Tudorza Pressair and tell your doctor right away.

• sudden difficulty breathing
• sudden and abnormal swelling of the lips, mouth, and/or tongue
• sudden onset of a red blister-like skin rash (hives)
• sudden drop in blood pressure

• your breathing problems worsen with Tudorza Pressair
• you need to use your rescue inhaler medicine more often that usual
• your rescue inhaler medicine does not work as well for you at relieving your symptoms 

Before taking Tudorza Pressair, tell your doctor about all your medical conditions, especially tell your doctor if you:

• are allergic to Tudorza Pressair or to any of its ingredients
• have eye problems, especially glaucoma
• have prostate problems 
• have bladder problems, or problems passing urine
• have a severe allergy to milk proteins
• you are pregnant or plan to become pregnant
• you are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines and eye drops, vitamins, and herbal supplements.

Use Tudorza Pressair exactly as prescribed.

• Tudorza Pressair comes in a dry powder inhaler form and is typically inhaled into the lungs twice daily. The usual dose of Tudorza Pressair is one inhalation by mouth, two times a day, about 12 hours apart. 
• Tudorza Pressair will not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine for a bronchospasm attack.  
• Tudorza Pressair inhaler has a dose indicator to show you how many doses are left in your inhaler. Each Tudorza Pressair inhaler has 60 doses of medicine. When you start using the inhaler for the first time you will see the number 60 in the dose indicator.You will see the number of doses count down in the dose indicator as you use the inhaler. The dose indicator moves down slowly, displaying intervals of 10 (60, 50, 40, 30, 20, 10, 0). When a red band begins to appear in the dose indicator, this means you are nearing your last dose and should obtain a new Tudorza Pressair inhaler.
• If your Tudorza Pressair inhaler appears to be damaged or if you lose the cap, your inhaler should be replaced.
• You do not need to clean your Tudorza Pressair 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 Tudorza Pressair inhaler, as this may damage your medicine. 
• Always follow your healthcare provider's instructions on use exactly. You may refer to the following section for additional information on appropriate use of Tudorza Pressair.

Preparing for use

1. When you are ready to use Tudorza Pressair for the first time, remove the Tudorza Pressair inhaler from the pouch. To remove the inhaler from the pouch, tear along the “notch.” The pouch may then be discarded.
2. Remove the protective cap by lightly squeezing the arrows marked on each side of the cap and pulling outwards. Look to see that nothing is blocking the mouthpiece.
3. Hold the Tudorza Pressair inhaler with the mouthpiece facing you, but not inside your mouth. The green button should be facing straight up
4. Before you put the inhaler into your mouth, press the green button all the way down. Then release the green button. Do not continue to hold the green button down.
5. Stop and check the control window to make sure your dose is ready for inhalation. Look to see if the colored control window has changed from red to green. The green control window tells you that your medicine is ready for inhalation. If the control window stays red, repeat the press and release actions until the control window is green. Now the dose is ready to be inhaled.

Administration

1. Before you put the inhaler into your mouth, breathe out completely. Do not breathe out into the inhaler.
2. Put your lips tightly around the mouthpiece of the Tudorza Pressair inhaler. Breathe in quickly and deeply through your mouth. This quick, deep breath makes sure that you get enough of the medication from the inhaler into your lungs. Breathe in until you hear a “click” sound. Keep breathing in, even after you have heard the inhaler “click” to be sure you get the full dose. (DON'T HOLD the green button down while you are inhaling)
3. Remove the Tudorza Pressair inhaler from your mouth and hold your breath for as long as is comfortable, then breathe out slowly through your nose. Some people may taste the medicine during their inhalation. Do not take an extra dose even if you do not taste anything after inhaling.
4. Stop and check the control window. Look at the control window to see if it has turned to red from green. If the window is red you have inhaled your full dose of medicine correctly. If the window does not change to red, you may have forgotten to release the green button before inhaling or may not have inhaled correctly. If that happens repeat Step 2 again. Make sure you have released the green button and take a quick and deep breath in through the mouthpiece. If you are unable to inhale correctly after several attempts, call your doctor.
5. Once the window has turned red, place the protective cap back onto the inhaler by pressing it back onto the mouthpiece. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Tudorza Pressair at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Tudorza Pressair for the long-term maintenance treatment of symptoms of chronic obstructive pulmonary disease (COPD) is 400 mcg (one inhalation) inhaled by mouth, typically twice per day.