Description
Umeclidinium and vilanterol combination is used as maintenance treatment of air flow blockage in patients with chronic obstructive pulmonary disease (COPD). COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing).
Umeclidinium and vilanterol combination should not be used for acute breathing problems or in patients with asthma.
Inhaled umeclidinium is an anticholinergic. Inhaled vilanterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- 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
Umeclidinium and vilanterol combination is not for use in the pediatric population. 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 umeclidinium and vilanterol 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
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Nelfinavir
- Pimozide
- Piperaquine
- Posaconazole
- 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
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arotinolol
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atenolol
- Azithromycin
- Bedaquiline
- Befunolol
- Benzhydrocodone
- Betaxolol
- Bevantolol
- Bisoprolol
- Boceprevir
- Bopindolol
- Bucindolol
- Bupranolol
- Buprenorphine
- Bupropion
- Buserelin
- Carteolol
- Carvedilol
- Celiprolol
- Ceritinib
- Chloroquine
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
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—Should not be used in patients with these conditions.
- Bladder blockage or
- Diabetes or
- Enlarged prostate (BPH, prostatic hyperplasia) or
- Heart or blood vessel disease 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
- Narrow-angle glaucoma or
- Problems passing urine or
- Seizures or
- Thyroid problems (eg, thyrotoxicosis)—Use with caution. May make these conditions worse.
- Liver disease, severe—Use has not been studied in patients with this condition.
Proper Use
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.
Inhaled umeclidinium and vilanterol combination comes with a patient information leaflet and patient instructions. Read the directions carefully before using this 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 to prevent COPD attacks.
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 foil tray. Peel back the lid to open the tray.
- Slide the inhaler cover down until you hear a clicking sound. The inhaler is now ready to use. Do not open the cover of the inhaler until you are ready to use it. If you open and close the inhaler without inhaling the dose, you will lose the medicine.
- Turn your head away from the inhaler, and breathe out fully. Do not breathe into the inhaler.
- Put the mouthpiece between your lips, and close your lips around the mouthpiece. Do not block the air vent with your fingers.
- Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.
- Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 3 or 4 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
- When you are finished, you may clean the mouthpiece with a dry tissue, if needed, before closing the inhaler cover.
- The inhaler has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the inhaler has less than 10 doses left, the left half of the counter will show up in red 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 dosage form (powder):
- For maintenance treatment of COPD:
- Adults—One inhalation once a day. Do not take more than one inhalation every 24 hours.
- Children—Use is not recommended.
- For maintenance treatment of COPD:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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 this medicine in a dry place away from heat and sunlight. Throw it away 6 weeks after opening or when the counter reads "0".
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.
Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.
This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.
Talk with your doctor or get medical care right away if:
- Your symptoms do not improve after using this medicine for 1 week or if they become worse.
- Your short-acting inhaler does not seem to work as well as it used to and you need it more often than normal (eg, you use 1 whole canister of the short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of the short-acting inhaler for 2 or more days in a row).
- You have a big decrease in your peak flow when measured as directed by your doctor.
This medicine should not be used together with similar inhaled medicines, such as arformoterol (Brovana®), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist®), indacaterol (Onbrez®), or salmeterol (Serevent®).
This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.
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. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
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 you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain.
Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: decreased urine, dry mouth, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, uneven heartbeat, or unusual tiredness or weakness.
This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar 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:
Less common
- Body aches or pain
- chest pain
- congestion
- cough
- dryness or soreness of the throat
- fever
- headache
- hoarseness
- pain or tenderness around the eyes and cheekbones
- stuffy or runny nose
- tender, swollen glands in the neck
- tightness of the chest
- trouble breathing
- trouble swallowing
- voice changes
Rare
- Chest discomfort
- dizziness
- fainting
- fast or irregular heartbeat
- itching, skin rash
- nausea
- pain or discomfort in the arms, jaw, back, or neck
- sweating
- vomiting
Incidence not known
- Blindness
- blurred vision
- burning feeling while urinating
- change in vision
- decrease in frequency of urination
- decreased vision
- difficult or painful urination
- difficulty in passing urine (dribbling)
- eye pain
- fast, irregular, pounding, or racing heartbeat or pulse
- hives, itching, skin rash
- irritation
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- tearing
- tremor
- unusual tiredness or weakness
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
- Diarrhea
- difficulty having a bowel movement
- muscle spasms
Rare
- Belching
- burning, dry, or itching eyes
- discharge or excessive tearing
- dry mouth
- heartburn
- indigestion
- lack or loss of strength
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- stomach discomfort, upset, or pain
Incidence not known
- Anxiety
- change in or lack of taste
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.
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