In the U.S.—

In Canada—

• Anti-inflammatory, inhalation
• antiasthmatic

Fluticasone (floo-TIK-a-sone) 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.

Inhaled fluticasone works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

This medicine may be used with other asthma medicines, such as bronchodilators (medicines that open up narrowed breathing passages) or other corticosteroids taken by mouth.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Inhalation
• Aerosol (U.S. and Canada)
• Powder for inhalation (U.S. and Canada)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For inhaled fluticasone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fluticasone. Also tell your health care professional if you are allergic to any other substances, such as foods, especially milk, preservatives, or dyes.

Pregnancy—Inhaled fluticasone has not been studied in pregnant women. However, in animal studies, fluticasone given by injection was shown to cause birth defects. Also, too much use of corticosteroids during pregnancy may cause other unwanted effects in the infant, such as slower growth and reduced adrenal gland function.

Breast-feeding—It is not known whether inhaled fluticasone passes into breast milk. However, in animals given fluticasone by injection, the medicine did pass into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

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.

Older adults—Inhaled fluticasone has been studied in elderly patients and has not been found to cause different side effects or other problems than it does in younger adults.

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. Tell your health care professional if you are taking any prescription or nonprescription (over-the-counter [OTC]) medicines.

• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, or fungus)—Inhaled fluticasone may make these infections worse

• Tuberculosis (active or history of)—Inhaled fluticasone may cause this infection to start up again

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 health care professional.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. 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.

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.

Inhaled fluticasone is used with a special inhaler and usually comes with patient directions. 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 health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

For patients using the inhalation aerosol:

• When you use the inhaler for the first time, or if you have not used it for 4 weeks or longer, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine into the air four times. (Spray the inhaler once into the air if it has not been used in 1 to 3 weeks.) The inhaler will now be ready to give the right amount of medicine when you use it.
• To use the inhaler:
  • Shake the inhaler well for 15 seconds immediately before each use.
  • Take the cap off the mouthpiece (the strap will stay attached to the actuator). Check the mouthpiece and remove any foreign objects. Make sure the canister is fully and firmly inserted into the actuator.
  • Hold the mouthpiece away from your mouth and breathe out slowly and completely.
  • Use the inhalation method recommended by your doctor.
    • Open-mouth method—Place the mouthpiece about 1 or 2 inches (two fingerwidths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so that the spray does not hit the roof of your mouth or your tongue.
    • Closed-mouth method—Place the mouthpiece in your mouth between your teeth and over your tongue, with your lips closed tightly around it. Do not block the mouthpiece with your teeth or tongue.
  • Tilt your head back a little. Start to breathe in slowly and deeply through your mouth and, at the same time, press the top of the canister one time to get one puff of the medicine. Continue to breathe in slowly for 5 to 10 seconds. Count the seconds while inhaling. It is important to press the top of the canister and breathe in slowly at the same time so the medicine is pulled into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly.
  • Hold your breath as long as you can up to 10 seconds. This gives the medicine time to settle in your airways and lungs.Take the mouthpiece away from your mouth and breathe out slowly.
  • If your doctor has told you to inhale more than one puff of medicine at each dose, wait about 30 seconds and then gently shake the inhaler again, and take the second puff following exactly the same steps you used for the first puff.
  • When you are finished, wipe off the mouthpiece and replace the cover to keep the mouthpiece clean and free of foreign objects.
• Clean the inhaler and mouthpiece at least once a day to prevent buildup of medicine and blockage of the mouthpiece.
  • To clean the inhaler:
    • Remove the metal canister from the inhaler and set it aside.
    • Rinse the mouthpiece and cover and plastic case in warm, running water.
    • Shake off the excess water and let the inhaler parts air dry completely before replacing the metal canister and cover.

For patients using the powder for inhalation:

• To load the inhaler:
  • Make sure your hands are clean and dry.
  • Do not insert the disk until just before you are ready to use the medicine.
  • Take off the mouthpiece cover and make sure that the mouthpiece is clean.
  • Hold the corners of the white tray and pull out gently until you can see all of the plastic ridges on the sides of the tray.
  • Put your finger and thumb on the ridges, squeeze inward, and gently pull the tray out of the body of the inhaler.
  • Place a disk on the wheel with the numbers facing up, and then slide the tray back into the inhaler.
  • Hold the corners of the tray and slide the tray out and in. This will rotate the disk.
  • Continue to turn the disk in this way until the number 4 appears in the small window. Each disk has four blisters containing the medicine. The window will display how many inhalations you have left after you use it each time. For example, when you see the number 1, you have one inhalation left.
  • To replace the empty disk with a full disk, follow the same steps you used to load the inhaler. Do not throw away the wheel when you discard the empty disk.
• To use the inhaler:
  • Hold the inhaler flat in your hand. Lift the rear edge of the lid until it is fully upright.
  • The plastic needle on the front of the lid will break the blister containing one inhalation of medicine. When the lid is raised as far as it will go, both the upper and the lower surfaces of the blister will be pierced. Do not lift the lid if the cartridge is not in the inhaler. Doing this will break the needle and you will need a new inhaler.
  • After the blister is broken open, close the lid. Keeping the inhaler flat and well away from your mouth, breathe out to the end of a normal breath.
  • Raise the inhaler to your mouth, and place the mouthpiece in your mouth.
  • Close your lips around the mouthpiece and tilt your head slightly back. Do not bite down on the mouthpiece. Do not block the mouthpiece with your teeth or tongue. 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.
  • Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 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 to the end of a normal breath.
  • Prepare the cartridge for your next inhalation. Pull the cartridge out once and push it in once. The disk will turn to the next numbered dose as seen in the indicator window. Do not pierce the blister until just before the inhalation.
  • If your doctor has told you to inhale more than one puff of medicine at each dose, take the second puff following exactly the same steps you used for the first puff.
  • When you are finished, wipe off the mouthpiece and replace the cover to keep the mouthpiece clean and free of foreign objects.
• To clean the inhaler:
  • Remove the tray from the body of the inhaler.
  • Hold the wheel between your forefinger and thumb and pull upward to separate it from the tray.
  • Use the brush that is stored in the rear of the body of the inhaler to brush away any powder left behind on the parts of the inhaler.
  • Replace the wheel and push it down firmly until it snaps back into place.
  • Replace the tray and mouthpiece cover.
  • Separate the parts of the inhaler using the steps outlined above.
  • Rinse the parts of the inhaler with warm water and let them air dry before reassembling them as described above.
  The inhaler should be cleaned once a week.

Dosing—

The dose of inhaled fluticasone 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 inhaled fluticasone. If your dose is different, do not change it unless your doctor tells you to do so.

The number of puffs that you take or disks that you use depends on the strength of the medicine.

• For bronchial asthma
  • For inhalation aerosol:
    • Adults and children 12 years of age and older—88 to 880 micrograms (mcg) two times a day, morning and evening. Canadian labeling recommends—For adults and children 16 and older: 100 to 1000 mcg two times a day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.Canadian labeling recommends—For children 4 to 16 years of age: 50 to 100 mcg two times a day; For children up to 4 years of age: Use and dose must be determined by your doctor.
  • For powder for inhalation:
    • Adults and children older than 11 years of age—100 to 1000 mcg two times a day.
    • Children 4 to 11 years of age—50 to 100 mcg two times a day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    Canadian labeling recommends—For children 4 to 16 years of age: 50 to 100 mcg two times a day.

Missed dose—

If you miss a dose of this medicine, use it as soon as you remember. Then use any remaining doses for that day at regularly spaced times. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the powder (disk) form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the aerosol form of this medicine from freezing. This medicine may be less effective if the container is cold when you use it.
• Do not puncture, break, or burn the aerosol container, even after it is empty.
• The blisters should be used within 2 months after opening the moisture-protective foil wrap or before the expiration date, whichever comes first.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Check with your doctor if:

• You go through a period of unusual stress to your body, such as surgery, injury, or infection.
• You have an asthma attack that does not improve after you take a bronchodilator medicine.
• Your asthma symptoms do not improve or your condition worsens.
• You are exposed to the chickenpox or measles.

Your doctor may want you to carry a medical identification 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.

Before you have any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using 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 mouth and throat 
  
  

• Less common
  • Diarrhea;  ear ache;  fever;  lower abdominal pain;  nausea;  pain on passing urine;  redness or discharge of the eye, eyelid, or lining of the eye;  shortness of breath;  sore throat;  trouble in swallowing;  vaginal discharge (creamy white) and itching;  vomiting 
  
  

• Rare
  • Blindness, blurred vision, eye pain;  large hives;  bone fractures;  diabetes mellitus [increased hunger, thirst, or urination];  excess facial hair in women;  fullness or roundness of face, neck, and trunk;  growth reduction in children or adolescents;  heart problems;  high blood pressure;  hives and skin rash;  impotence in males;  lack of menstrual periods;  muscle wasting;  numbness and weakness of hands and feet;  weakness ;  swelling of face, lips, or eyelids;  tightness in chest, troubled breathing, or wheezing 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Cough;  general aches and pains or general feeling of illness;  greenish-yellow mucus in nose ;  headache;  hoarseness or other voice changes;  loss of appetite;  runny, sore, or stuffy nose;  unusual tiredness;  weakness 
  
  

• Less common
  • Bloody mucus or unexplained nosebleeds;  dizziness;  eye irritation;  feeling 'faint';  giddiness;  irregular or painful menstrual periods;  irritation due to inhalant;  joint pain;  migraines;  mouth irritation;  muscle soreness, sprain, or strain;  sneezing;  stomach pain or burning 
  
  

• Rare
  • Aggression;  agitation;  bruising;  depression;  itching;  restlessness;  weight gain 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in the product labeling, fluticasone propionate is used in certain patients with the following medical conditions:

• Pulmonary disease, chronic obstructive