Aclidinium (Inhalation route)
- Tudorza Pressair
- Aerosol Powder
Uses of This Medicine:
Aclidinium 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).
Aclidinium 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.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of inhaled aclidinium in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled aclidinium in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to atropine, or history of or
- Difficult urination or
- Enlarged prostate or
- Glaucoma, narrow angle or
- Urinary bladder blockage—Use with caution. May make these conditions worse.
- Allergy to milk proteins, or history of—Should not be used in patients with this condition.
Proper Use of This Medicine:
Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may cause your lung condition to become worse.
This medicine usually comes with patient instructions. Read them carefully before using the medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you how to use it.
To use the Pressair®:
- This medicine comes in sealed pouch. Do not open the sealed pouch until you are ready to use a dose of this medicine.
- Once opened, remove the inhaler from the pouch.
- Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear.
- Press the green button all the way down and release it.
- Check the control window to make sure your dose is ready for inhalation. Look if the colored control window changed from red to green.
- To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Put your lips tightly around the mouthpiece and breathe in quickly and deeply until you hear a "click" sound. Keep breathing in, even after you hear the "click" sound to be sure you get the full dose.
- Do not hold the green button while you are breathing in.
- Remove the inhaler from your mouth and hold your breath for as long as is comfortable, and then breathe out slowly through your nose.
- Stop and check the colored control window if it has turned to red. This means you have inhaled full dose of this medicine.
- If the control window is still colored green, repeat the steps above. If you are unable to inhale correctly after several attempts, call your doctor.
- Once the window has turned red, place the cap back by pressing it back into the mouthpiece.
- If you want to clean the inhaler, wipe the mouthpiece with a dry tissue or towel. Do not use water to clean the inhaler, as this may damage the medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For inhalation aerosol dosage form (used with an inhaler):
- For bronchospasm caused by COPD:
- Adults—One puff two times a day (spaced 12 hours apart). Each puff contains 400 micrograms (mcg) of aclidinium bromide.
- Children—Use and dose must be determined by your doctor.
- For bronchospasm caused by COPD:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.
Do not store this medicine in a vibrating surface.
Throw away the inhaler 45 days after opening the pouch, after a "0" with a red background shows, or when the device locks out.
Precautions While Using This Medicine:
It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to help reduce any unwanted effects.
Check with your doctor at once if your symptoms do not improve or if your condition gets worse.
This medicine will not stop bronchospasm that has already started. Your doctor may prescribe another medicine for you to use in case of an acute attack.
This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.
Check with your doctor right away if you have any changes to your eyes, such as eye pain or discomfort, blurred vision, visual halos, or colored images with red eyes while you are using this medicine. Your doctor may want your eyes to be checked by an eye doctor. These could be symptoms of acute narrow-angle glaucoma.
This medicine may cause serious allergic reactions. These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
Call your doctor right away if you use other medicines for your lung condition and they do not seem to be working as well as usual. Do not change your doses or stop using your medicines before you talk to your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.
Side Effects of This Medicine:
- Incidence not known
- Decrease in the frequency of urination
- decrease in urine volume
- difficulty in passing urine (dribbling)
- eye pain and blurred vision
- painful urination
- More common
- muscle aches
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- Less common
- pain or tenderness around the eyes and cheekbones
- troubled breathing
- Chest pain or discomfort
- difficulty with moving
- dilated neck veins
- dry mouth
- extreme fatigue
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- loss of consciousness
- muscle pain or stiffness
- pain, swelling, or redness in the joints
- slow or irregular heartbeat
- swelling of the face, fingers, feet, or lower legs
- unexplained weight loss
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017