How Is TUDORZA Taken?

TUDORZA is taken by breathing the medication in through an inhaler called PRESSAIR.
The important parts of the PRESSAIR inhaler are labeled in the picture below.

How Is the PRESSAIR Inhaler Used?

Taking a dose from the PRESSAIR inhaler requires you to press and release the green button, and then inhale. For a complete description of how to use TUDORZA PRESSAIR, see the step-by-step Instructions for Use within the full Prescribing Information. For how to prepare and use the inhaler, see the instructions below or view the PRESSAIR Inhaler Video.

How to prepare and use your
TUDORZA PRESSAIR Inhaler

STEP 1

Remove the protective cap by lightly squeezing the arrows marked on each side of the cap and pulling outwards. (See Figure B)

Look to see that nothing is blocking the mouthpiece.

STEP 2

Hold the TUDORZA PRESSAIR inhaler with the mouthpiece facing you, but not inside your mouth. The green button should be facing straight up. (See Figure C)

STEP 3

Before you put the inhaler into your mouth, press the green button all the way down.
(See Figure D)

Then release the green button.
(See Figure E)
Do not continue to hold the green button down.

STEP 4

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 (See Figure F) to green (See Figure G)

The green control window tells you that your medicine is ready for inhalation.
(See Figure G)
If the control window stays red (See Figure F), repeat the Press and Release actions in Step 3 until the control window is green.

Now the dose is ready to be inhaled.

STEP 5

Before you put the inhaler into your mouth, breathe out completely. Do not breathe out into the inhaler.

Put your lips tightly around the mouthpiece of the TUDORZA PRESSAIR inhaler. Breathe in quickly and deeply through your mouth. (See Figure H). 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.
Do not hold down the green button while you are breathing in. (See Figure I)

STEP 6

Remove the TUDORZA PRESSAIR inhaler from your mouth and hold your breath for as long as is comfortable (See Figure J), 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.

STEP 7

Stop and Check the Control Window. Make sure you have used your TUDORZA PRESSAIR inhaler correctly.

Look at the control window to see if it has turned to red (See Figure K) from green (See Figure L). If the window is red you have inhaled your full dose of medicine correctly.

If the colored control window is still green, repeat Step 5.

If the window still 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 5 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.

STEP 8

Once the window has turned red, place the protective cap back onto the inhaler by pressing it back onto the mouthpiece. (See Figure M)

Return to Beginning

When should I get a new
PRESSAIR Inhaler?

A red band will begin to appear within the dose indicator when you are nearing your last dose, which means you should obtain a new PRESSAIR inhaler. You should discard the inhaler and start a new one when:

The marking "0" with the red background shows in the middle of the dose indicator (See Figure O), or
The device locks out (See Figure P), or
45 days have passed since you took the inhaler out of the sealed pouch, whichever comes first

If your TUDORZA PRESSAIR inhaler appears to be damaged, or if you lose the cap, your inhaler should be replaced.

To see the PRESSAIR inhaler in action, view the Inhaler Video

INDICATIONS AND USAGE

TUDORZA™ PRESSAIR™ is a prescription medicine used long term, 2 times each day to treat symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

TUDORZA is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

IMPORTANT RISK INFORMATION

What important information should I know about TUDORZA?

TUDORZA is not a rescue medication and does not relieve sudden breathing problems. Always have a rescue inhaler medicine with you to treat sudden symptoms.

What should I tell my doctor before using TUDORZA?

Before you use TUDORZA, tell your doctor about all your medical conditions, including if you have eye problems (especially glaucoma), prostate or bladder problems, or problems passing urine. TUDORZA may make these problems worse. You should also let your doctor know if you have a severe allergy to milk proteins.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines and eyedrops. Especially tell your doctor if you take anticholinergics (including tiotropium, ipratropium) and atropine.

Do not use TUDORZA more often than prescribed or take more medicine than prescribed for you.

Seek immediate medical help if your breathing problems worsen with TUDORZA, you need to use your rescue inhaler more often than usual, or your rescue inhaler does not work as well for you.

What are the possible side effects of TUDORZA?

TUDORZA can cause serious side effects. Stop taking TUDORZA and seek medical help right away if you experience:

Sudden shortness of breath immediately after use of TUDORZA
New or worsened symptoms of increased pressure in your eyes (acute narrow-angle glaucoma), which may include eye pain, nausea or vomiting, blurred vision, seeing halos or bright colors around lights, or red eyes. Using only eyedrops to treat these symptoms may not work and if not treated, this could lead to permanent loss of vision
Symptoms of new or worsened urinary retention (difficult, painful, or frequent urination, or urination in a weak stream or drips)
Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems

What are the most common side effects of TUDORZA?

The most common side effects of TUDORZA include headache, common cold symptoms, and cough. These are not all the possible side effects with TUDORZA.

Please also see the full Prescribing Information, including Patient Information.

TUDORZA PRESSAIR (aclidinium bromide inhalation powder) Prescribing Information. Forest Pharmaceuticals, Inc. St. Louis, MO

Data on file. Forest Laboratories, Inc.

Kerwin EM, D’Urzo AD, Gelb AF, et al, on behalf of the ACCORD 1 study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012;9:90-101.