Description
Aclidinium and formoterol combination is used as maintenance treatment in patients with chronic obstructive pulmonary disease (COPD). It will not relieve a COPD attack that has already started or an asthma attack.
Inhaled aclidinium and formoterol are long-acting bronchodilators. These are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Aerosol Powder
Before Using
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:
Allergies
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.
Pediatric
Use of aclidinium and formoterol combination is not recommended in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aclidinium and formoterol combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Isocarboxazid
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Potassium Chloride
- Potassium Citrate
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
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.
- Acebutolol
- Adagrasib
- Alfuzosin
- Amantadine
- Amifampridine
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atenolol
- Azithromycin
- Bedaquiline
- Bemetizide
- Bendroflumethiazide
- Benzhydrocodone
- Benzthiazide
- Betaxolol
- Bisoprolol
- Bumetanide
- Buprenorphine
- Bupropion
- Buserelin
- Carteolol
- Carvedilol
- Celiprolol
- Ceritinib
- Chloroquine
- Chlorothiazide
- Chlorpromazine
Other Interactions
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 milk proteins, severe or
- Asthma or
- Bronchospasm (difficulty with breathing), acute—Should not be used in patients with these conditions.
- Bladder blockage or
- Diabetes or
- Enlarged prostate or
- Glaucoma, history of or
- Heart or blood vessel disease (eg, coronary insufficiency) or
- Heart rhythm problems (eg, arrhythmia, prolonged QT interval) or
- Hypertension (high blood pressure) or
- Hypokalemia (low potassium in the blood) or
- Ketoacidosis (high ketones in the blood) or
- Problems passing urine or
- Seizures or
- Thyrotoxicosis (excess thyroid hormone in the body)—Use with caution. May make these conditions worse.
Proper Use
Inhaled aclidinium and formoterol combination is used to treat chronic obstructive pulmonary disease (COPD). It is not used to relieve a COPD attack that has already started. For relief of an COPD attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.
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 increase the chance of side effects.
This medicine is used with a special inhaler that comes with a patient information leaflet and patient instructions. Read the directions 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 what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.
Use this medicine at the same time each day.
Do not stop using this medicine or other breathing medicines that your doctor has prescribed for you unless you have discussed this with your doctor.
To use the inhaler:
- This medicine comes in a sealed bag. Do not open the bag until you are ready to use the inhaler. Do not press the orange button until you are ready to take a dose.
- Remove the cap by squeezing and pulling it off the mouthpiece. Check the mouthpiece to make sure it is clear.
- Hold the inhaler with the mouthpiece facing you and the orange button is on top. Press the orange button all the way down and release it. Do not tilt the inhaler.
- Check the control window to make sure your dose is ready for inhalation. Look if the colored control window changed from red to green. If it is still red, repeat the steps to prepare your dose.
- 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 orange 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. You may have a grainy feeling or a slightly sweet or bitter taste in your mouth after inhalation. Do not take an extra dose if you do not taste or feel anything after inhaling.
- Check the colored control window if it has turned to red. This means you have inhaled the full dose of this medicine. If it 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.
- To clean the inhaler, wipe the mouthpiece with a dry tissue or towel. Do not use water to clean it, as this may damage the medicine.
- The inhaler has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. A red band will appear in the window to remind you to refill your prescription.
Dosing
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 (powder):
- For maintenance treatment of COPD:
- Adults—One inhalation 2 times a day, in the morning and evening. Each inhalation contains 400 micrograms (mcg) of aclidinium bromide and 12 mcg of formoterol fumarate.
- Children—Use and dose must be determined by your doctor.
- For maintenance treatment of COPD:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
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 on a vibrating surface.
Throw away the inhaler 2 months after opening the bag, after a "0" with a red background shows, or when the device is empty and locks out.
Precautions
It is very important that your doctor check your progress at regular visits to see if this medicine is working properly and to check for any unwanted effects.
Tell your doctor about other medicines you are using for COPD. Follow your doctor's instructions on how you should take your medicine.
This medicine should not be used if you are having a COPD attack, or if symptoms of a COPD attack has already started. Your doctor will prescribe another medicine for you to use in case of an acute attack. If the other medicine does not work as well, tell your doctor right away.
This medicine should not be used together with similar inhaled medicines, such as arformoterol (Brovana®), formoterol (Foradil®, Perforomist®), glycopyrrolate (Robinul®), indacaterol (Onbrez®), ipratropium (Atrovent, Apovent®, Ipraxa®, Rinatec®), olodaterol (Striverdi® Respimat®), salmeterol (Serevent®), tiotropium (Spiriva®, Braltus®), umeclidinium (Incruse™ Ellipta®), or vilanterol.
This medicine may increase the chance of asthma-related problems. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.
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.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
This medicine may increase your risk for heart and blood vessel problems, including changes in heart rhythm. Check with your doctor right away if you have dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or fast or irregular heartbeat.
Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
This medicine may affect blood sugar and potassium levels. If you have heart disease or diabetes and notice a change in the results of your blood or urine sugar or potassium tests, check with 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 and herbal or vitamin supplements.
Side Effects
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:
More common
- Body aches or pain
- chills
- cough
- difficulty in breathing
- ear congestion
- fever
- headache
- loss of voice
- runny or stuffy nose
- sneezing
- sore throat
- unusual tiredness or weakness
Less common
- Bladder pain
- bloody or cloudy urine
- diarrhea
- difficult, burning, or painful urination
- frequent urge to urinate
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- lower back or side pain
- muscle aches and pains
- nausea
- pain or tenderness around the eyes and cheekbones
- shivering
- sweating
- tightness of the chest
- trouble sleeping
- vomiting
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred vision
- dizziness
- fast, pounding, or irregular heartbeat or pulse
- headache
- muscle spasms
- nervousness
- pounding in the ears
- slow heartbeat
- tremor
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:
Less common
- Back, arm, or leg pain
- bone pain
- difficulty in moving
- dry mouth
- mouth or throat pain
- muscle stiffness
- toothache
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.
CON-XXXXXXXX
