Fluticasone and Salmeterol

Fluticasone/salmeterol is a prescription medication used to treat asthma and COPD. It is a single product containing 2 medications: fluticasone and salmeterol. Fluticasone belongs to a class of medications called steroids. These work by reducing swelling in the airways. Salmeterol belongs to a class of drugs called long-acting beta-agonists (LABAs). These work by relaxing and opening air passages in the lungs, making it easier to breathe.

This medication comes in an inhaler form and is typically used twice a day, in the morning and evening, about 12 hours apart.

Common side effects of fluticasone/salmeterol include upper respiratory tract infection, throat irritation, hoarseness and voice changes, and thrush in the mouth or throat.

Fluticasone/salmeterol can also cause drowsiness. Do not drive or operate heavy machinery until you know how fluticasone/salmeterol affects you.

Fluticasone/salmeterol is a prescription medication used to treat asthma and chronic obstructive pulmonary disease (COPD). The condition COPD is a group of lung diseases that includes chronic bronchitis and emphysema.

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

Fluticasone and Salmeterol may be found in some form under the following brand names:

• Advair Diskus

• Advair HFA

• AirDuo Digihaler

• AirDuo RespiClick

• Wixela Inhub

Serious side effects have been reported with fluticasone/salmeterol.  See the "Drug Precautions" section.

Common side effects of fluticasone/salmeterol include the following:

• upper respiratory tract infection
• throat irritation
• hoarseness and voice changes
• thrush in your mouth or throat
• bronchitis
• cough
• headache
• nausea
• vomiting
• viral respiratory infections
• muscle and bone pain

This is not a complete list of fluticasone/salmeterol side effects.  Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.  Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• non-potassium-sparing diuretics such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex)

This is not a complete list of fluticasone/salmeterol drug interactions.  Ask your doctor or pharmacist for more information.

Serious side effects have been reported with fluticasone/salmeterol including the following:

• increased risk of death from asthma problems. People with asthma who take long-acting beta2 adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in fluticasone/salmeterol), have an increased risk of death from asthma problems.
• pneumonia. People with COPD have a higher chance of getting pneumonia. Fluticasone/salmeterol may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: increase in mucus production, change in mucus color, fever, chills, increased cough, and increased breathing problems.
• immunosuppression. Fluticasone/salmeterol may increase the chance of getting infections.
• adrenal insufficiency. Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones.  This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as fluticasone/salmeterol). When your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.  Symptoms of adrenal insufficiency include the following: feeling tired, lack of energy, weakness, nausea and vomiting, and low blood pressure.
• thrush. Fluticasone/salmeterol can cause a fungal infection in your mouth or throat.  It is important to rinse your mouth with water without swallowing after using fluticasone/salmeterol to help reduce your chance of getting thrush.
• sudden breathing problems immediately after inhaling your medicine. Call your healthcare provider if breathing problems worsen over time while using fluticasone/salmeterol.
• serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash, hives, swelling of your face, mouth, and tongue, and breathing problems.
• effects on the heart. fluticasone/salmeterol can cause increased blood pressure, a fast or irregular heartbeat, and chest pain.
• effects on the nervous system. Fluticasone/salmeterol can cause a tremor and nervousness.
• osteoporosis. Fluticasone/salmeterol can cause bone thinning or weakness.
• slowed growth in children. A child's growth should be checked often.
• glaucoma and cataracts. Fluticasone/salmeterol can cause eye problems. It is important to have regular eye exams while using fluticasone/salmeterol.
• changes in laboratory blood values. Fluticasone/salmeterol can cause changes in your sugar, potassium, and certain types of white blood cells.

Fluticasone/salmeterol can cause drowsiness. Do not drive or operate heavy machinery until you know how fluticasone/salmeterol affects you.

Do not take fluticasone/salmeterol in the following situations:

• are allergic to fluticasone/salmeterol or to any of its ingredients
• have a severe allergy to milk proteins
• treatment of a sudden attack of asthma or COPD

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of fluticasone/salmeterol, there are no specific foods that you must exclude from your diet when receiving this medication.

You should not use fluticasone/salmeterol if you have a severe allergy to milk proteins. See the "Drug Precautions" section.

Before taking fluticasone/salmeterol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to fluticasone/salmeterol or to any of its ingredients
• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have osteoporosis (weak bones)
• have an immune system problem
• have eye problems such as glaucoma or cataracts
• have any type of viral, bacterial, or fungal infection
• are exposed to chickenpox or measles
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fluticasone/salmeterol falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if fluticasone/salmeterol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using fluticasone/salmeterol.

Take fluticasone/salmeterol exactly as prescribed.

Fluticasone/salmeterol comes in two different types of inhalers and is typically used twice a day, in the morning and evening, about 12 hours apart.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluticasone/salmeterol at the same time.

Fluticasone/salmeterol Diskus Instructions:

• Write the date you opened the foil pouch in the first blank line on the label.
• Write the "use by" date in the second blank line on the label, which is 1 month after the date you wrote on the first line.
• The counter should read 60. If you have a sample or institutional pack, then the counter should read 14.

Follow these instructions each time you use your inhaler:

• Open your fluticasone/salmeterol Diskus by holding it in your left hand and placing the thumb of your right hand in the thumb grip. Push the thumb grip away from you as far as it will go until the mouthpiece shows and snaps into place.
• Slide the lever until you hear it click. Hold the inhaler in a level, flat position with the mouthpiece towards you. Slide the lever away from the mouthpiece as far as it will go until it clicks. The number on the counter will count down by 1, and it is now ready to use.
• Do not close the inhaler, do not tilt the inhaler, and do not move the lever on the inhaler so that you do not accidentally waste a dose.
• Before you breathe in your dose from the inhaler, breathe out (exhale) as long as you can while you hold the inhaler level and away from your mouth. Do not breathe into the mouthpiece.
• Put the mouthpiece to your lips, and breathe in quickly and deeply through the inhaler. Do not breathe in through your nose.
• Remove the inhaler from your mouth and hold your breathe for about 10 seconds, or for as long as is comfortable for you. Breathe out slowly as long as you can.
• The inhaler delivers your dose of medicine as a very fine powder that you may or may not taste or feel. Do not take an extra dose from the inhaler even if you do not taste or feel the medicine.
• Close the inhaler by placing your thumb in the thumb grip and slide it back towards you as far as it will go. Make sure the inhaler clicks shut, and you cannot see the mouthpiece.
• Rinse your mouth with water after breathing in the medicine, and spit out the water. Do not swallow the water.
• After you have taken 55 doses (9 doses from the sample or institutional pack), it is time to get a refill from your pharmacy.

Fluticasone/salmeterol HFA Inhaler Instructions:

• Take fluticasone/salmeterol HFA out of the foil pouch just before you use it for the first time.
• The counter should read 124 or 064 depending on which size inhaler you have.
• Safely throw away the pouch and the drying packet that comes inside the pouch.
• The inhaler should be at room temperature before you use it.

Follow these instructions each time you use your inhaler:

1) Before you use fluticasone/salmeterol HFA for the first time, you must prime the inhaler so that you will get the right amount of medicine when you use it.

• To prime the inhaler, take the cap off the mouthpiece and shake the inhaler well for 5 seconds.
• Then spray the inhaler 1 time into the air away from your face.
• Shake and spray the inhaler like this 3 more times to finish priming it.
• The counter should now read 120 or 060, depending on which size inhaler you have.
• You must prime your inhaler again if you have not used it in more than 4 weeks or if you drop it. Take the cap off the mouthpiece and shake the inhaler well for 5 seconds. Then spray it 1 time into the air away from your face. Shake and spray the inhaler like this 1 more time to finish priming it.

2) Before each use:

• Shake the inhaler well for 5 seconds before each spray.
• Take the cap off the mouthpiece of the actuator. Look inside the mouthpiece for foreign objects, and take out any you see.
• Hold the inhaler with the mouthpiece down.
• Breathe out through your mouth and push as much air from your lungs as you can. Put the mouthpiece in your mouth and close your lips around it
• Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth.
• After the spray comes out, take your finger off the canister. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth.
• Hold your breath for about 10 seconds, or for as long as is comfortable. Breathe out slowly as long as you can.
• Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it
• Put the cap back on the mouthpiece after every time you use the inhaler. Make sure it snaps firmly into place.

3) Cleaning your fluticasone/salmeterol HFA inhaler:

• Clean your inhaler at least 1 time each week after your evening dose. You may not see any medicine build-up on the inhaler, but it is important to keep it clean so medicine build-up will not block the spray.
• Take the cap off the mouthpiece. The strap on the cap will stay attached to the actuator. Do not take the canister out of the plastic actuator.
• Use a dry cotton swab to clean the small circular opening where the medicine sprays out of the canister. Carefully twist the swab in a circular motion to take off any medicine.
• Wipe the inside of the mouthpiece with a clean tissue dampened with water. Let the actuator air-dry overnight.
• Put the cap back on the mouthpiece after the actuator has dried.

When the counter reads 020, you should refill your prescription or ask your healthcare provider if you need another prescription for fluticasone/salmeterol HFA.

When the counter reads 000, throw the inhaler away. You should not keep using the inhaler when the counter reads 000 because you may not receive the right amount of medicine.

Do not use the inhaler after the expiration date, which is on the packaging it comes in.

Take this medication exactly as prescribed by your doctor.  Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of fluticasone/salmeterol Diskus for the treatment of asthma in people 4 years of age and older is 1 inhalation twice a day, in the morning and evening, about 12 hours apart.

The recommended dose of fluticasone/salmeterol Diskus for the treatment of COPD in adults is 1 inhalation twice a day, in the morning and evening, about 12 hours apart.

The recommended dose of fluticasone/salmeterol HFA for the treatment of asthma in people 12 years of age and older is 2 inhalation twice a day, in the morning and evening, about 12 hours apart.

If you take too much fluticasone/salmeterol, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If fluticasone/salmeterol is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Fluticasone/salmeterol Diskus:

• Store fluticasone/salmeterol Diskus at room temperature.
• Keep fluticasone/salmeterol Diskus in a dry place away from heat and sunlight.
• Store fluticasone/salmeterol Diskus in the unopened foil pouch and only open when ready for use.
• Safely throw away fluticasone/salmeterol Diskus in the trash 1 month after you open the foil pouch or when the counter reads 0, whichever comes first.

Fluticasone/salmeterol HFA:

• Store fluticasone/salmeterol HFA at room temperature.
• The contents of your fluticasone/salmeterol HFA are under pressure: Do not puncture. Do not use or store near heat or open flame. Temperatures above 120°F may cause the canister to burst. 
• Safely throw away fluticasone/salmeterol HFA in the trash when the counter reads 000. 

Keep this and all medicines out of reach of children.

Keep all appointments with your doctor.

Black Box Warning: Asthma-related death

Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in fluticasone/salmeterol, increase the risk of asthma-related death. A US trial showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 out of 13,179 subjects on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. 

When treating patients with asthma, only prescribe fluticasone/salmeterol for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue fluticasone/salmeterol) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use fluticasone/salmeterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.