Pronunciation:

floo-TIK-a-sone

Brand Names:

• Armonair Digihaler with eModule
• Armonair Respiclick
• Arnuity Ellipta
• Flovent
• Flovent Diskus
• Flovent HFA
• Flovent Rotadisk

Dosage Forms:

• Powder
• Aerosol Powder

Classifications:

Therapeutic—

Anti-Inflammatory

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

Fluticasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It is used to help prevent the symptoms of asthma. When used regularly (every day), inhaled fluticasone decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

This medicine must be used with a short-acting medicine (eg, albuterol) for an asthma attack or asthma symptoms that need attention right away.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Corticosteroids taken by mouth or injection have been shown to slow or stop growth in children and cause reduced adrenal gland function. If enough fluticasone is absorbed following inhalation, it is possible it also could cause these effects. Your doctor will want you to use the lowest possible dose of fluticasone that controls asthma. This will lessen the chance of an effect on growth or adrenal gland function. It is also important that children taking fluticasone visit their doctors regularly so that their growth rates may be monitored. Children who are taking this medicine may be more susceptible to infections, such as chickenpox or measles. Care should be taken to avoid exposure to chickenpox or measles. If the child is exposed or the disease develops, the doctor should be contacted and his or her directions should be followed carefully. Before this medicine is given to a child, you and your child's doctor should talk about the good this medicine will do as well as the risks of using it.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ArmonAir® Digihaler™ and Flovent® HFA in children 4 years of age and older as maintenance treatment for asthma. However, safety and efficacy have not been established for ArmonAir® Digihaler™ and Flovent® HFA in children younger than 4 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone in the elderly. However, elderly patients are more sensitive to the effects of Arnuity® Ellipta®, Flovent® Diskus®, or Flovent® HFA than younger adults. Elderly patients are also more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving Armonair® or Arnuity® Ellipta®. .

Breast-feeding—

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.

Other medicines—

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.

• Desmopressin
• Levoketoconazole

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.

• Adagrasib
• Aspirin
• Atazanavir
• Belzutifan
• Bemiparin
• Boceprevir
• Bupropion
• Ceritinib
• Clarithromycin
• Cobicistat
• Conivaptan
• Dabrafenib
• Darunavir
• Dasabuvir
• Duvelisib
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Idelalisib
• Indinavir
• Itraconazole
• Ivosidenib
• Josamycin
• Ketoconazole
• Larotrectinib
• Lefamulin
• Lenacapavir
• Lonafarnib
• Lopinavir
• Lorlatinib
• Lumacaftor
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Mibefradil
• Mifepristone
• Nadroparin
• Nefazodone
• Nelfinavir
• Netupitant
• Nirmatrelvir
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Phenobarbital
• Pirtobrutinib
• Posaconazole
• Primidone
• Ribociclib
• Ritlecitinib
• Ritonavir
• Saquinavir
• Sargramostim
• Somatrogon-ghla
• Telaprevir
• Telithromycin
• Tipranavir
• Tocilizumab
• Trofinetide
• Troleandomycin
• Tucatinib
• Voriconazole

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

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:

• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute or
• Milk protein allergy, severe—Should not be used in patients with these conditions.

• Blood vessel disease (eg, Churg-Strauss syndrome) or
• Bone problems (eg, osteoporosis) or
• Cataracts or
• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, or fungus) or
• Measles 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 of This Medicine:

Inhaled fluticasone is used to prevent asthma attacks. It is not used to relieve an 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. The full benefit of this medicine may take 1 to 2 weeks or longer to achieve.

This medicine comes with a patient information leaflet and patient instructions. Read these instructions 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.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Gargling and 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.

To use the ArmonAir™ RespiClick® or ArmonAir® Digihaler™:

• Take the inhaler out of the pouch before you use it for the first time.
• Do not use the inhaler for this medicine with any other medicine.
• This medicine does not require priming. Do not use it with a spacer or volume holding chamber.
• Hold the inhaler upright and open the green cap all the way until it clicks. Do not open the green cap until you are ready to take a dose of this medicine.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue. Do not block the vent above the mouthpiece with your lips or fingers.
• Breathe in through your mouth quickly and deeply as you can until you have taken a full deep breath. Hold your breath for about 10 seconds.
• Close the green cap after each inhalation. Rinse your mouth with water without swallowing after each inhalation.
• Keep the inhaler dry and clean at all times. Gently wipe the mouthpiece with a dry cloth or tissue as needed.
• The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the dose counter displays 0, 30 days after opening the pouch.

To use the Arnuity® Ellipta®:

• This medicine comes in foil tray. Peel back the lid to open.
• Before you use this medicine, the counter should show the number 30. The counter counts down by 1 each time you open the cover.
• Open the cover of the inhaler until you hear a clicking sound. The inhaler is now ready to use.
• Do not close the cover until you have taken your dose. If you open and close the cover without inhaling the dose, you will lose the medicine.
• Hold the inhaler away from your mouth and breathe out fully. Do not breathe out into the mouthpiece.
• Close your lips around the mouthpiece. Do not cover the air holes on the side of the mouthpiece.
• Breathe in through your mouth as steadily and as deeply as you can until you have taken a full deep breath. Do not breathe in 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 to 4 seconds before breathing out. This gives the medicine time to settle in your airways and lungs.
• Hold the inhaler well away from your mouth and breathe out slowly and gently.
• You may clean the mouthpiece with a dry tissue before you close the cover.
• When the dose counter reaches "10", call your doctor or pharmacist if refill is needed. Throw away the inhaler when the dose counter is at "0".

To use the Flovent® Diskus®:

• Take the inhaler out of the pouch before you use it for the first time.
• To open it, push the thumb grip away from you as far as it will go. You will hear a click and feel a snap. When open, the mouthpiece will appear.
• Slide the mouthpiece lever away from you as far as it will go until it clicks. The inhaler is now ready to use. Do not close, tilt, or move the lever.
• Turn your head away from the inhaler, and breathe out to the end of a normal breath. Do not breathe into the inhaler.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.
• Remove the mouthpiece from your mouth and hold your breath for about 10 seconds or for as long as you can, before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• If your doctor has told you to take more than one inhalation of medicine at each dose, take the second inhalation using exactly the same steps you used for your first dose.
• The inhaler will deliver your medicine as a very fine powder. Do not take another dose even if you cannot taste or feel it.
• When you are finished, close the inhaler. Place your thumb on the thumb grip, and slide it back towards you as far as it will go. You will hear it click shut.
• Rinse your mouth with water after breathing in the medicine. Do not swallow.
• The inhaler has a window that shows the number of doses left. This tells you when you are getting low on medicine. When the inhaler has 5 doses left, the numbers from 5 to 0 will show up in red to remind you to refill your prescription.
• Do not wash the inhaler. Always keep it dry. Do not use it with a spacer device.

To use the Flovent® HFA:

• When you use the inhaler for the first time, or if you have not used it for 7 days or longer, it may not deliver the right amount of medicine with the first puff. Test or prime it first by spraying the medicine into the air 4 times, away from your face. Avoid spraying in your eyes. Spray the inhaler once into the air if it has not been used in 7 days. The inhaler will now be ready to give the right amount of medicine when you use it.
• Shake the inhaler well for 5 seconds immediately before each use.
• Take the cap off the mouthpiece (the strap will stay attached to the actuator). Inspect the mouthpiece for the presence of foreign objects and make sure that the canister is fully and firmly inserted into the actuator.
• Breathe out fully through your mouth, expelling as much air from your lungs as possible. Place the mouthpiece fully into your mouth, holding the inhaler in the mouthpiece-down position and closing your lips around it.
• While breathing in deeply and slowly through your mouth, fully depress the top of the metal canister with your finger. Immediately after the puff is delivered, release your finger from the canister and remove the inhaler from your mouth.
• Hold your breath for about 10 seconds or for as long as you can, before breathing out slowly. This gives the medicine time to settle in your airway and lungs.
• If your doctor has told you to inhale more than one puff or inhalation , wait about 30 seconds, then gently shake the inhaler for 5 seconds. Take the second inhalation using exactly the same steps you used for your first dose.
• Rinse your mouth with water after breathing in the medicine. Do not swallow.
• Replace the cap on the mouthpiece after each use.
• Clean the actuator or mouthpiece at least once a week. Gently wipe the small circular opening where the medicine is sprayed out with a clean cotton swab dampened with water. Wipe the inside of the mouthpiece with a clean tissue dampened with water. Let it air dry overnight.
• The inhaler has a dose counter that keeps track of how many more times you can use it before you need to open a new one. When the dose counter reaches "020", call your doctor or pharmacist if refill is needed.
• If the dose counter is not working correctly, do not use the inhaler and return it to your pharmacy or doctor. Do not change the numbers or remove the counter from the canister. .

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 maintenance treatment of asthma:
  • For inhalation dosage form (ArmonAir® Digihaler™):
    • Adults and children 12 years of age and older—At first, 113 or 232 micrograms (mcg) 2 times a day (about 12 hours apart). Some patients may start on 55 mcg 2 times a day. Your doctor may adjust your dose as needed.
    • Children 4 to 11 years of age—30 mcg 2 times a day (about 12 hours apart). Some patients may start on 55 mcg 2 times a day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
• For preventing an asthma attack:
  • For inhalation dosage form (aerosol):
    • Adults and children 12 years of age and older—At first, 88 micrograms (mcg) 2 times a day (about 12 hours apart). Your doctor may adjust your dose as needed. However, the dose is usually not more than 880 mcg 2 times a day.
    • Children 4 to 11 years of age—88 mcg 2 times a day (about 12 hours apart).
    • Children younger than 4 years of age—Use and dose must be determined by your doctor. .
  • For inhalation dosage form (ArmonAir™ RespiClick® inhalation powder):
    • Adults and children 12 years of age and older—At first, 55 mcg two times a day (about 12 hours apart). Your doctor may adjust your dose as needed. Do not use this medicine more than 2 times every 24 hours.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For inhalation dosage form (Arnuity® Ellipta® inhalation powder):
    • Adults and children 12 years of age and older— At first, 100 micrograms (mcg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mcg per day.
    • Children 5 to 11 years of age—50 mcg once a day.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For inhalation dosage form (Flovent® Diskus® inhalation powder):
    • Adults and children 12 years of age and older—At first, 100 mcg two times a day (about 12 hours apart). Your doctor may adjust your dose as needed. However, the dose is usually not more than 1000 mcg two times per day.
    • Children 4 to 11 years of age—At first, 50 mcg two times a day (about 12 hours apart). Your doctor may increase your dose as needed. However, the dose is usually not more than 100 mcg two times per day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

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.

If you miss a dose of ArmonAir™ Respiclick®, Flovent® Diskus®, or Flovent® HFA, 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.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Store the Flovent® HFA inhaler with the mouthpiece down.

Precautions While Using This Medicine:

If you will be using this medicine for a long time, it is very important that your doctor check your or you child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Although this medicine decreases the number of asthma episodes, it may increase the chance of a severe asthma attack when they do occur. 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.

You should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.

Talk with your doctor or get medical care right away if:

• Your or your child's symptoms do not improve after using this medicine for 2 weeks or if they become worse.
• Your short-acting inhaler does not seem to work as well as it used to and you or your child 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 or your child have a big decrease in your peak flow when measured as directed by your doctor.

This medicine may cause a 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.

Do not change your dose or stop using your medicine without first asking your doctor.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

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 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.

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, or wheezing after using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with 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 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 your or your child's eyes be checked by an ophthalmologist (eye doctor).

This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

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 of This Medicine:

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

White patches in the mouth and throat

Less common

Bone pain

diarrhea

ear ache

fever

lower abdominal or stomach pain

nausea

pain on passing urine

redness or discharge of the eye, eyelid, or lining of the eye

sore throat

trouble swallowing

vaginal discharge (creamy white) and itching

vomiting

Rare

Blindness, blurred vision, eye pain

bone fractures

chest tightness

excess facial hair in women

fullness or roundness of the face, neck, and trunk

growth reduction in children or teenagers

heart problems

high blood pressure

hives, skin rash

impotence in males

increased hunger, thirst, or urination

lack of menstrual periods

muscle wasting

numbness and weakness of the hands and feet

swelling of the face, lips, or eyelids

trouble breathing

weakness

Incidence not known

Dizziness

fast heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Darkening of the skin

fainting

loss of appetite

mental depression

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:

More common

Cough

general aches and pains or general feeling of illness

greenish-yellow mucus in the nose

headache

hoarseness or other voice changes

runny, sore, or stuffy nose

Less common

Bloody mucus or unexplained nosebleeds

eye irritation

headache, severe and throbbing

irregular or painful menstrual periods

joint pain

mouth irritation

muscle soreness, sprain, or strain

sneezing

stomach pain

Rare

Aggression

agitation

bruising

itching

restlessness

weight gain

Incidence not known

Decrease in height

dry mouth

flushed, dry skin

fruit-like breath odor

loss of voice

pain in the back, ribs, arms or legs

sweating

trouble sitting still

unexplained weight loss

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.