Fluticasone oral inhalation is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma in adults and children 4 years of age and older. It is in a class of medications called corticosteroids. Fluticasone works by decreasing swelling and irritation in the airways to allow for easier breathing.

Fluticasone comes as an aerosol to inhale by mouth using an inhaler and as a powder to inhale by mouth using an inhaler. Fluticasone aerosol oral inhalation (Flovent^® HFA) is usually inhaled twice daily. Fluticasone powder for oral inhalation (Flovent^® Diskus) is usually inhaled twice daily. Try to use fluticasone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use fluticasone exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Talk to your doctor about how you should use your other oral and inhaled medications for asthma during your treatment with fluticasone inhalation. If you are using any other inhaled medications, ask your doctor if you should inhale these medications a certain amount of time before and after you inhale fluticasone inhalation. If you were taking an oral steroid such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos), your doctor may want to gradually decrease your steroid dose starting at least 1 week after you begin to use fluticasone.

Fluticasone helps to prevent asthma attacks (sudden episodes of shortness of breath, wheezing, and coughing) but will not stop an asthma attack that has already started. Do not use fluticasone during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during asthma attacks.

Your doctor will probably start you on an average dose of fluticasone. Your doctor may decrease your dose when your symptoms are controlled or increase it if your symptoms have not improved after at least 2 weeks.

Fluticasone controls asthma but does not cure it. Your symptoms may improve 24 hours after you begin using fluticasone, but it may take 2 weeks or longer before you feel the full benefit of the medication. Continue to use fluticasone even if you feel well. Do not stop using fluticasone without talking to your doctor.

Tell your doctor if your asthma worsens during your treatment. Call your doctor if you have an asthma attack that does not stop when you use your fast-acting asthma medication, or if you need to use more of your fast-acting medication than usual.

The inhaler that comes with fluticasone aerosol is designed for use only with a canister of fluticasone. Never use it to inhale any other medication, and never use any other inhaler to inhale fluticasone.

Each product is designed to provide 60 or120 inhalations, depending on the type of inhaler. After the labeled number of inhalations has been used, later inhalations may not contain the correct amount of medication. You should keep track of the number of inhalations you have used. You can divide the number of inhalations in your inhaler by the number of inhalations you use each day to find out how many days your inhaler will last. Dispose of the canister after you have used the labeled number of inhalations even if it still contains some liquid and continues to release a spray when it is pressed. Do not float the canister in water to see if it still contains medication.

Do not use your fluticasone aerosol inhaler while you are near an open flame or a heat source. The inhaler may explode if it is exposed to very high temperatures.

Before you use fluticasone the first time, read the written instructions that come with it. Look at the diagrams carefully and be sure that you recognize all the parts of the inhaler. Ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the inhaler while he or she watches.

To use the aerosol inhaler, follow these steps:

1. Before you use the aerosol inhaler for the first time, remove it from the overwrap. Dispose of the overwrap and the drying packet that is inside the overwrap.
2. Be sure that the inhaler is at room temperature.
3. Remove the cap from the mouthpiece. The strap on the side of the cap will stay attached to the actuator to keep the cap from getting lost. Check the mouthpiece for dirt and other objects before each use, especially if the cap was not used to cover the mouthpiece.
4. Be sure the canister is fully and firmly inserted in the actuator. Shake the inhaler well for 5 seconds.
5. If you are using the inhaler for the first time, prime it by releasing four test sprays into the air, away from your face. Shake the inhaler for 5 seconds before each spray. If you have not used the inhaler in more than 7 days, or if you have dropped the inhaler, shake the inhaler for 5 seconds and release one spray into the air. Be careful not to spray the medication into your eyes.
6. Breathe out through your mouth.
7. Hold the inhaler facing you with the mouthpiece on the bottom. Place your thumb under the mouthpiece and your index finger on the top of the canister. Place the mouthpiece in your mouth and close your lips around it.
8. Breathe in deeply and slowly through your mouth. At the same time, press down firmly on the top of the canister with your index finger. Remove your index finger as soon as the spray is released.
9. When you have breathed in fully, remove the inhaler from your mouth and close your mouth.
10. Try to hold your breath for 10 seconds.
11. If your doctor told you to inhale more than one puff, wait 30 seconds, shake the canister again, and repeat steps 6 through 10 for each puff.
12. Put the cap back on the mouthpiece.
13. Rinse your mouth with water and spit the water out. Do not swallow the water.

Clean your aerosol inhaler once a week after an evening dose. To clean your inhaler, follow these steps:

1. Remove the mouthpiece cap, but leave the canister in the actuator.
2. Dampen the tip of a cotton swab with water. Use the damp swab to clean the small hole where the medication comes out. Twist the swab in a circular motion to remove any medication that is left in or near the hole.
3. Repeat step 2 with a second cotton swab.
4. Dampen a clean tissue with water. Wipe the inside of the mouthpiece with the damp tissue.
5. Leave the mouthpiece uncovered overnight to allow it to air dry.
6. Replace the mouthpiece cap when the actuator is dry.

To inhale the powder using the inhaler, follow these steps. Do not use the diskus inhaler with a spacer:

1. If you are using a new inhaler for the first time, remove it from the foil pouch. Write the date that you opened the inhaler in the space provided on the cap label.
2. Hold the inhaler in your left hand and place 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.
3. Hold the inhaler in a level, flat position with the mouthpiece toward you. Slide the lever away from the mouthpiece as far as it will go until it clicks.
4. Before you breathe in your dose from the inhaler, exhale as long as you can while you hold the inhaler level and away from your mouth. Do not close, tilt, or move the inhaler lever. Do not breathe into the inhaler.
5. Place the mouthpiece between your lips well into your mouth. Close your lips tightly around the mouthpiece. Inhale deeply and quickly. Do not breath in through your nose. nose. Adults giving the treatment to young children may hold the child’s nose closed to be sure that the medication goes into the child’s throat.
6. Remove the inhaler from your mouth and hold your breath for about 10 seconds. Do not blow or exhale through the inhaler.
7. If you inhale two puffs, repeat steps 4 through 6.
8. Replace the protective cap on the inhaler and twist it shut.
9. After each treatment, rinse your mouth with water and spit. Do not swallow the water.Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

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

Before using fluticasone oral inhalation,

• Tell your doctor and pharmacist if you are allergic to fluticasone, any other medications, or any of the ingredients in fluticasone inhalation. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or have recently taken. Be sure to mention any of the following: antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole (Nizoral); clarithromycin (Biaxin); HIV protease inhibitors such as atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak, others), and saquinavir (Invirase); medications for seizures, nefazodone; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); and telithromycin (Ketek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with fluticasone oral inhalation so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• Do not use fluticasone inhalation during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during asthma attacks. Call your doctor if you have an asthma attack that does not stop when using the fast-acting asthma medication, or if you need to use more of the fast-acting medication than usual.
• If you are using any other inhaled medications, ask your doctor if you should inhale these medications a certain amount of time before or after you inhale fluticasone inhalation.
• Tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become thin and weak and break easily) and if you have or have ever had tuberculosis (TB; a type of lung infection) in your lungs, cataracts (clouding of the lens of the eye), glaucoma (an eye disease), or liver disease. Also tell your doctor if you have any type of untreated infection anywhere in your body or a herpes eye infection (a type of infection that causes a sore on the eyelid or eye surface), or if you are on bedrest or unable to move around.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using fluticasone, call your doctor.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are using fluticasone.
• If you have any other medical conditions, such as asthma, arthritis, or eczema (a skin disease), they may worsen when your oral steroid dose is decreased. Tell your doctor if this happens or if you experience any of the following symptoms during this time: extreme tiredness, muscle weakness, or pain; sudden pain in stomach, lower body, or legs; loss of appetite; weight loss; upset stomach; vomiting; diarrhea; dizziness; fainting; depression; irritability; and darkening of skin. Your body may be less able to cope with stress such as surgery, illness, severe asthma attack, or injury during this time. Call your doctor right away if you get sick and be sure that all healthcare providers who treat you know that you recently replaced your oral steroid with fluticasone inhalation. Carry a card or wear a medical identification bracelet to let emergency personnel know that you may need to be treated with steroids in an emergency.
• Tell your doctor if you have never had chickenpox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away. You may need treatment to protect you from these infections.
• You should know that fluticasone inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, use your fast-acting (rescue) asthma medication right away and call your doctor. Do not use fluticasone inhalation again unless your doctor tells you that you should.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Fluticasone inhalation may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Headache
• Stuffy or runny nose
• Hoarseness
• Sore or irritated throat
• Painful white patches in the mouth or throat
• Fever
• Ear infection

Some side effects can be serious. If you experience any of the following symptoms or those in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• Hives
• Rash
• Itching
• Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Difficulty breathing or swallowing
• Cough
• Shortness of breath

Fluticasone may cause children to grow more slowly. There is not enough information to tell whether using fluticasone decreases the final height that children will reach when they stop growing. Your child’s doctor will watch your child’s growth carefully while your child is using fluticasone. Talk to your child’s doctor about the risks of giving this medication to your child.

In rare cases, people who used fluticasone for a long time developed glaucoma or cataracts. Talk to your doctor about the risks of using fluticasone and how often you should have your eyes examined during your treatment.

Fluticasone may increase your risk of developing osteoporosis. Talk to your doctor about the risks of using this medication.

Fluticasone may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Store your fluticasone aerosol inhaler with the mouthpiece pointing down. Store it out of reach of children, at room temperature and away from excess heat and moisture (not in the bathroom). If you are using the fluticasone powder for inhalation 50 mcg, you must dispose of the inhaler 6 weeks after opening the foil pouch. If you are using the fluticasone powder for inhalation 100 mcg or 250 mcg, you must dispose of the inhaler 2 months after opening the foil pouch. Do not store the inhaler near a heat source or an open flame. Protect the inhaler from freezing and direct sunlight. Do not puncture the aerosol container and do not dispose of it in an incinerator or fire.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.