Generic Name: aclidinium bromide inhalation powder
Date of Approval: July 23, 2012
Company: Forest Laboratories, Inc. and Almirall, S.A.
Treatment for: Chronic Obstructive Pulmonary Disease (COPD)
FDA Approves Tudorza Pressair
The U.S. Food and Drug Administration (FDA) has approved Tudorza Pressair (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Tudorza is a twice-daily inhaled long-acting anticholinergic, also referred to as a long-acting muscarinic antagonist (LAMA). When given by inhalation, aclidinium produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Aclidinium is rapidly hydrolyzed in human plasma into two major inactive metabolites.
Tudorza is administered using a multiple-dose dry powder inhaler, Pressair, which delivers 60 doses of aclidinium bromide powder for inhalation. The Pressair inhaler has a colored control window and audible “click” which confirm successful inhalation of the dose and a dose indicator to let patients know how many doses remain in the inhaler.
Important Safety Information
Tudorza Pressair is not indicated for the initial treatment of acute episodes of bronchospasm (i.e., rescue therapy).
Inhaled medicines, including Tudorza, may cause paradoxical bronchospasm. If this occurs, treatment with Tudorza should be stopped and other treatments considered.
Tudorza should be used with caution in patients with narrow-angle glaucoma or urinary retention. Instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma or prostatic hyperplasia or bladder-neck obstruction develop.
Immediate hypersensitivity reactions may occur after administration of Tudorza. If such a reaction occurs, therapy with Tudorza should be stopped at once and alternative treatments considered. Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to Tudorza. Use with caution in patients with severe hypersensitivity to milk proteins.
Tudorza Pressair Patient Information
Read the Patient Information that comes with Tudorza Pressair before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your doctor about your medical condition or your treatment.
What is Tudorza Pressair?
Tudorza Pressair is a prescription medicine used long term, two times each day to treat symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. You may start to feel like it is easier to breathe on the first day, but it may take longer for you to feel the full effects of the medicine. Tudorza Pressair works best and may help make it easier to breathe when you use it every day.
Tudorza Pressair 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.
It is not known if Tudorza Pressair is safe and effective in children. What should I tell my doctor before using Tudorza Pressair?
Before you use Tudorza Pressair, tell your doctor about all your medical conditions, including if you:
- have eye problems, especially glaucoma. Tudorza Pressair may make your glaucoma worse.
- have prostate or bladder problems, or problems passing urine. Tudorza Pressair may make these problems worse.
- have a severe allergy to milk proteins. Ask your doctor if you are not sure.
- are pregnant or plan to become pregnant. It is not known if Tudorza Pressair can harm your unborn baby.
- are breastfeeding or plan to breastfeed. Tudorza Pressair may pass into your breast milk. You and your doctor should decide if you will take Tudorza Pressair.
Tell your doctor about all the medicines you take, including prescription and non prescription medicines and eye drops, vitamins, and herbal supplements.
Tudorza Pressair and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your doctor if you take:
- anticholinergics (including tiotropium, ipratropium)
Ask your doctor or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist each time you get a new medicine.
How should I use Tudorza Pressair?
See the Tudorza Pressair package insert for step-by-step instructions for use.
- Use Tudorza Pressair exactly as prescribed.
- The usual dose of Tudorza Pressair is one oral inhalation two times a day. Each dose should be about 12 hours apart.
- If you miss a dose, just skip the dose. Take your next dose at your usual time. Do not take two doses at one time. Tudorza Pressair does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your doctor to have one prescribed for you. Do not use Tudorza Pressair more often than prescribed or take more medicine than prescribed for you.
- Call your doctor or get emergency medical care right away if:
- your breathing problems worsen with Tudorza Pressair
- you need to use your rescue inhaler medicine more often than usual
- your rescue inhaler medicine does not work as well for you at relieving symptoms
Tudorza Pressair side effects
Tudorza Pressair can cause serious side effects including:
- sudden shortness of breath immediately after use of Tudorza Pressair. If you have this symptom, stop taking Tudorza Pressair and call your doctor right away or go to the nearest hospital emergency room.
- new or worsened increased pressure in your eyes (acute narrow-angle glaucoma). Acute narrow-angle glaucoma can lead to permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
- eye pain or discomfort
- nausea or vomiting
- blurred vision
- seeing halos or bright colors around lights
- red eyes
- new or worsened urinary retention. 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
- serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your doctor or get emergency medical care if you get any symptoms of a serious allergic reaction.
The most common side effects of Tudorza Pressair include:
- common cold symptoms
If your COPD symptoms worsen over time do not increase your dose of Tudorza Pressair, instead call your doctor.
Tell your doctor if you get any side effect that bothers you or does not go away.
These are not all the possible side effects with Tudorza Pressair. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Tudorza Pressair side effects (in more detail)
How should I store Tudorza Pressair?
Store Tudorza Pressair at room temperature between 68°F to 77°F (20° to 25°C) in the protective pouch. Do not open the sealed pouch until you are ready to use a dose of Tudorza Pressair. Once a sealed pouch is opened, start using your Tudorza Pressair. 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 Tudorza Pressair in a dry place.
- Do not store the inhaler on a vibrating surface.
Keep Tudorza Pressair and all medicines out of the reach of children.
General information about the safe and effective use of Tudorza Pressair
Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Tudorza Pressair for a condition for which it was not prescribed. Do not give Tudorza Pressair to other people even if they have the same symptoms that you have. It may harm them.
This patient leaflet summarizes the most important information about Tudorza Pressair. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Tudorza Pressair that is written for health professionals.
For more information, go to www.tudorza.com, or a call 1-800-678-1605.
What are the ingredients in Tudorza Pressair?
Active ingredient: aclidinium bromide
Inactive ingredient: lactose monohydrate