Description
Fluticasone and vilanterol combination is used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.
Fluticasone and vilanterol combination used to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is used long term to improve breathing problems and to reduce the number of COPD flare-ups (worsening of your COPD symptoms for several days). This medicine will not relieve a COPD attack that has already started.
Inhaled fluticasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause COPD and asthma symptoms.
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
Appropriate studies have not been performed on the relationship of age to the effects of fluticasone and vilanterol combination to treat asthma in children younger than 5 years of age and to treat chronic obstructive pulmonary disease (COPD) 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 fluticasone 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
- Desmopressin
- Dronedarone
- Fluconazole
- Levoketoconazole
- Mesoridazine
- Mifepristone
- Pimozide
- Piperaquine
- Posaconazole
- 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
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Anagrelide
- Apalutamide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arotinolol
- Arsenic Trioxide
- Asenapine
- Aspirin
- Astemizole
- Atazanavir
- Atenolol
- Avacopan
- Azithromycin
- Bedaquiline
- Befunolol
- Bemiparin
- Betaxolol
- Bevantolol
- Bisoprolol
- Boceprevir
- Bopindolol
- Bucindolol
- Bupranolol
- Buprenorphine
- Bupropion
- Buserelin
- Carbamazepine
- Carteolol
- Carvedilol
- Celiprolol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Auranofin
- Rotavirus Vaccine, Live
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, severe or
- Asthma attack, acute or
- Bronchospasm (difficulty with breathing), acute—Should not be used in patients with these conditions.
- Bone problems (eg, osteoporosis) or
- Cataracts, history of or
- Diabetes 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
- Hyperthyroidism (overactive thyroid) or
- Hypokalemia (low potassium in the blood) or
- Ketoacidosis (high ketones in the blood) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Chickenpox (including recent exposure) or
- Herpes simplex (virus) infection of the eye or
- Infections (eg, virus, bacteria, or fungus) or
- Measles (including recent exposure) or
- Tuberculosis, active or history of—Inhaled fluticasone can reduce the body's ability to fight off these infections.
- Infection or
- Stress or
- Surgery or
- Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.
- Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Inhaled fluticasone and vilanterol combination is used to prevent asthma attacks and treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma 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.
Inhaled fluticasone 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.
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.
Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.
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 treatment of asthma:
- Adults—One inhalation once a day. Each inhalation contains 100 or 200 micrograms (mcg) of fluticasone and 25 mcg of vilanterol.
- Children 12 to 17 years of age—One inhalation once a day. Each inhalation contains 100 mcg of fluticasone and 25 mcg of vilanterol.
- Children 5 to 11 years of age—One inhalation once a day. Each inhalation contains 50 mcg of fluticasone and 25 mcg of vilanterol.
- Children younger than 5 years of age—Use and dose must be determined by your doctor.
- For treatment and prevention of worsening attacks of COPD:
- Adults—One inhalation once a day. Each inhalation contains 100 micrograms (mcg) of fluticasone and 25 mcg of vilanterol.
- Children—Use is not recommended.
- For treatment of asthma:
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.
Do not take more than 1 inhalation per day.
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 away this medicine 6 weeks after it has been opened or when the counter reads 0.
Precautions
If you will be using this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for any unwanted effects. You may need to have your eyes checked at regular visits. Be sure to keep all appointments.
Tell your doctor what other medicines you are using for your asthma or COPD. Follow your doctor's instructions on how you should take these medicine.
This medicine should not be used if you are having an asthma or COPD attack, or if symptoms of an asthma or 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 may increase the chance of asthma-related problems. Be sure to read about these risks in the patient information leaflet and talk to your doctor or pharmacist about any questions or concerns that you have.
This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma. Talk to your doctor if you have concerns about this.
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 be working as well as usual and you need to use it more often (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 significant 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 weaken your immune system and increase your risk for infection. Tell your doctor about any immune system problems or infections, including herpes in your eye or tuberculosis. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.
This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.
This medicine may increase your risk of having pneumonia. Check with your doctor right away if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or increased breathing problems.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, lightheadedness, dizziness, or fainting, loss of appetite, mental depression, muscle pain or weakness, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Your doctor may want you to carry a medical identification (ID) card stating that you are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.
This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, or shortness of breath 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
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.
This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.
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 affect blood sugar and potassium levels. If you have heart disease or are diabetic and notice a change in the results of your blood or urine sugar or potassium tests, check with your doctor.
This medicine may cause a slowed growth in children. Talk with your doctor if you have any concerns about this.
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 with breathing
- ear congestion
- fever
- headache
- loss of voice
- muscle aches
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest pain or tightness
- diarrhea
- dizziness
- general feeling of discomfort or illness
- joint or muscle pain
- loss of appetite
- nausea
- nervousness
- pain or tenderness around the eyes and cheekbones
- pounding in the ears
- slow or fast heartbeat
- sweating
- tingling of the hands or feet
- trouble sleeping
- trouble breathing
- unusual weight gain or loss
- vomiting
Incidence not known
- Fast, irregular, pounding, or racing heartbeat or pulse
- muscle spasms
- noisy breathing
- tremor
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Arm, back, or jaw pain
- chest discomfort
- chest heaviness
- confusion
- decreased urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- fruit-like breath odor
- increased hunger or thirst
- increased urination
- loss of appetite
- muscle cramps
- numbness or tingling in the hands, feet, or lips
- rapid, deep breathing
- restlessness
- seizures
- shakiness in the legs, arms, hands, or feet
- stomach cramp or pain
- unexplained weight loss
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
- Creamy white, curd-like patches in the mouth or throat
- difficulty with moving
- muscle stiffness
- pain when eating or swallowing
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.
DRG-20061007
