Fluticasone and vilanterol

Fluticasone/vilanterol is a prescription medicine that is used to improve symptoms of COPD, a group of diseases that includes chronic bronchitis and emphysema. Fluticasone/vilanterol is used long-term to control wheezing, shortness of breath, coughing, and chest tightness caused by COPD. This medication is also used to treat asthma. 

This medication combines two active ingredients, fluticasone, a steroid that is effective at reducing airway swelling, and vilanterol, a long-acting beta agonist (LABA) which works by relaxing air passages, making it easier to breathe.

Fluticasone/vilanterol comes as an inhalation powder to inhale by mouth using a special inhaler. It is inhaled once daily, at the same time each day. 

Common side effects include runny nose, sore throat, upper respiratory tract infection, headache, and thrush.

Fluticasone/vilanterol is a prescription medication used to treat COPD, a chronic lung disease that includes chronic bronchitis, emphysema, or both. Fluticasone/vilanterol is used long-term to help improve symptoms of COPD for better breathing and to reduce the number of flare-ups. This medication is also used to treat asthma.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of another LABA (salmeterol) with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including vilanterol, an active ingredient.

You should not use this medicine if you are allergic to fluticasone, vilanterol, or milk proteins.

Fluticasone and vilanterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Fluticasone and vilanterol is a powder that comes with a special inhaler device preloaded with blister packs containing measured doses of the medicine. The device opens and loads a blister of fluticasone and vilanterol each time you use the inhaler. Follow the patient instructions provided with the inhaler device.

Fluticasone and vilanterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack. Use only a fast acting inhalation medicine for an asthma attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your symptoms.

The usual dose of this medicine is 1 inhalation per day. Use the medicine at the same time each day, and not more than once in a 24-hour period.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using your inhaler. Do not swallow.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

While using this medicine, you may need frequent blood tests. Your vision and your bone mineral density may also need to be checked.

Your doctor will need to check your lung function on a regular basis. Once your asthma is under control, your doctor may want you to stop using fluticasone and vilanterol. Keep all follow-up appointments and do not stop using the medicine unless your doctor tells you to.

Store at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

Throw the inhaler device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid such as fluticasone.

Do not use a second inhaled bronchodilator similar to vilanterol, such as salmeterol (Advair, Serevent), formoterol or arformoterol (Foradil, Perforomist, Symbicort, Brovana) unless your doctor has told you to.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

Fluticasone 100 mcg-vilanterol 25 mcg (1 inhalation) orally once a day
Maximum dose: 1 inhalation in 24 hours

Comments:
-This drug is not indicated for the relief of acute bronchospasm.
-Only fluticasone 100 mcg-vilanterol 25 mcg is indicated for the treatment of COPD.
-If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.

Uses: Long term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema; to reduce exacerbations in patients with COPD

Usual Adult Dose for Chronic Obstructive Pulmonary Disease:

Fluticasone 100 mcg-vilanterol 25 mcg (1 inhalation) orally once a day
Maximum dose: 1 inhalation in 24 hours

Comments:
-This drug is not indicated for the relief of acute bronchospasm.
-Only fluticasone 100 mcg-vilanterol 25 mcg is indicated for the treatment of COPD.
-If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.

Uses: Long term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema; to reduce exacerbations in patients with COPD

Usual Adult Dose for Asthma -- Maintenance:

Initial dose: 1 inhalation of fluticasone 100 mcg-vilanterol 25 mcg or fluticasone 200 mcg-vilanterol 25 mcg orally once a day
Maximum dose: 1 inhalation of fluticasone 200 mcg-vilanterol 25 mcg in 24 hours

Comments:
-This drug should not be used in asthma patients adequately controlled on low or medium dose inhaled corticosteroids.
-If asthma symptoms arise in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.
-The starting dosage is based on patients' asthma severity: For patients previously treated with low to mid dose corticosteroid, fluticasone 100 mcg-vilanterol 25 mcg should be considered; for patients previously treated with mid to high dose corticosteroid, fluticasone 200 mcg-vilanterol 25 mcg should be considered.

Use: In patients not adequately controlled on a long-term asthma medication, such as an inhaled corticosteroid, or when the severity of the disease clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA

• Breo Ellipta

Hypersensitivity to fluticasone, vilanterol, or any component of the formulation; severe hypersensitivity to milk proteins; primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required

Applies to fluticasone / vilanterol: inhalation powder

Along with its needed effects, fluticasone / vilanterol 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 while taking fluticasone / vilanterol:

• Body aches or pain
• chills, fever
• cough
• difficulty with breathing
• ear congestion
• headache
• loss of voice
• muscle aches
• sneezing
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• chest pain
• diarrhea
• dizziness
• general feeling of discomfort or illness
• joint or muscle pain
• loss of appetite
• nausea or vomiting
• nervousness
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• slow or fast heartbeat
• sweating
• tightness of the chest
• tingling of the hands or feet
• trouble sleeping
• troubled breathing
• unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur while taking fluticasone / vilanterol:

• Abdominal or stomach pain
• arm, back, or jaw pain
• chest discomfort
• chest tightness or heaviness
• confusion
• convulsions
• decreased urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• fast, irregular, pounding, or racing heartbeat or pulse
• fruit-like breath odor
• general feeling of discomfort or illness
• increased hunger or thirst
• increased urination
• loss of appetite
• muscle cramps
• numbness or tingling in the hands, feet, or lips
• rapid, deep breathing
• restlessness
• shakiness in the legs, arms, hands, or feet
• stomach cramps
• unexplained weight loss

Some side effects of fluticasone / vilanterol 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:

• Creamy white, curd-like patches in the mouth or throat
• difficulty with moving
• muscle stiffness
• pain when eating or swallowing

Initial dose: 1 inhalation of fluticasone 100 mcg-vilanterol 25 mcg or fluticasone 200 mcg-vilanterol 25 mcg orally once a day
Maximum dose: 1 inhalation of fluticasone 200 mcg-vilanterol 25 mcg in 24 hours

Comments:
-This drug should not be used in asthma patients adequately controlled on low or medium dose inhaled corticosteroids.
-If asthma symptoms arise in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.
-The starting dosage is based on patients' asthma severity: For patients previously treated with low to mid dose corticosteroid, fluticasone 100 mcg-vilanterol 25 mcg should be considered; for patients previously treated with mid to high dose corticosteroid, fluticasone 200 mcg-vilanterol 25 mcg should be considered.

Use: In patients not adequately controlled on a long-term asthma medication, such as an inhaled corticosteroid, or when the severity of the disease clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA