Flovent HFA (Fluticasone Oral Inhalation) Drug Information

Why is this medication prescribed?

Flovent HFA (fluticasone oral inhalation) is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Fluticasone is in a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.

How should this medicine be used?

Flovent HFA (fluticasone) comes as an aerosol to inhale by mouth. Flovent HFA (fluticasone) is usually inhaled twice a day. Try to use Flovent HFA (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 Flovent HFA (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 Flovent HFA (fluticasone) inhalation. If you were taking an oral steroid such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), or prednisone (Deltasone), your doctor may want to gradually decrease your steroid dose starting at least 1 week after you begin to use Flovent HFA (fluticasone). Special care will be needed in certain situations for several months as your body adjusts to the change in medication. Ask your doctor for more information.

Flovent HFA (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 Flovent HFA (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 Flovent HFA (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.

Flovent HFA (fluticasone) controls asthma but does not cure it. Your symptoms may improve 24 hours after you begin using Flovent HFA (fluticasone), but it may take 2 weeks or longer before you feel the full benefit of the medication. Continue to use Flovent HFA (fluticasone) even if you feel well. Do not stop using Flovent HFA (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 Flovent HFA (fluticasone) aerosol is designed for use only with a canister of Flovent HFA (fluticasone). Never use it to inhale any other medication, and never use any other inhaler to inhale Flovent HFA (fluticasone).

Each canister of Flovent HFA (fluticasone) aerosol is designed to provide 60 or 120 inhalations, depending on its size. 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. Throw away 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.

Before you use your Flovent HFA (fluticasone) aerosol inhaler 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.

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

To use the aerosol inhaler, follow these steps:

1. Before you use the inhaler for the first time, remove it from the overwrap. Throw away 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 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.

Other uses for this medicine

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

What special precautions should I follow?

Before using Flovent HFA (fluticasone) oral inhalation:

• tell your doctor and pharmacist if you are allergic to Flovent HFA (fluticasone) or any other medications.
• 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: amiodarone (Cordarone); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir) and saquinavir (Invirase, Fortovase); isoniazid (INH, Nydrazid); metronidazole (Flagyl); nefazodone; hormonal contraceptives (birth control pills, patches, rings, injections, or implants); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); paroxetine (Paxil);troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• 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 Flovent HFA (fluticasone) inhalation.
• tell your doctor if you have or have ever had tuberculosis (a type of 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 infection (a type of infection that causes a sore on the eyelid or eye surface) in your eye.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using Flovent HFA (fluticasone), call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using Flovent HFA (fluticasone).
• you should know that your body may be less able to cope with stress such as surgery, illness, severe asthma attack, or injury. Call your doctor right away if you get sick and be sure that all healthcare providers who treat you know that you are using Flovent HFA (fluticasone).
• 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 Flovent HFA (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 Flovent HFA (fluticasone) inhalation again unless your doctor tells you that you should.

What special dietary instructions should I follow?

Talk to your doctor about drinking grapefruit juice while taking this medication.

What should I do if I forget a dose?

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

What side effects can this medication cause?

Flovent HFA (fluticasone) may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• stuffy or runny nose
• difficulty speaking
• sore or irritated throat
• painful white patches in the mouth or throat

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• new or increased acne (pimples)
• easy bruising
• enlarged face and neck
• growth of hair on the face
• depression
• anxiety
• extreme tiredness
• muscle weakness
• irregular menstruation (periods)
• pink or purple stretch marks on the skin
• hives
• rash
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• chest pain or tightness
• cough
• shortness of breath
• red or fluid filled bumps on skin
• burning, tingling, numbness, or weakness in arms or legs

Flovent HFA (fluticasone) may cause children to grow more slowly. There is not enough information to tell whether using Flovent HFA (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 Flovent HFA (fluticasone).Talk to your child's doctor about the risks of giving this medication to your child.

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

Flovent HFA (fluticasone) may increase your risk of developing osteoporosis (a condition in which the bones become thin and weak and break easily). Talk to your doctor about the risks of using this medication.

Flovent HFA (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 [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Store your Flovent HFA (fluticasone) inhaler with the mouthpiece down.Store it out of reach of children, at room temperature and away from excess heat and moisture (not in the bathroom). Do not store the inhaler near a heat source or an open flame. Protect the inhaler from freezing and direct sunlight. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. Do not puncture the aerosol container and do not throw it away in an incinerator or fire.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Inhaling too much Flovent HFA (fluticasone) on a regular basis over a long period of time may cause the following symptoms:

• enlarged face and neck
• new or worsening acne
• easy bruising
• extreme tiredness
• muscle weakness
• irregular menstrual periods
• loss of appetite
• weight loss
• irritability
• depression
• fainting or dizziness when standing up from a sitting or lying position
• darkening of skin

What other information should I know?

Keep all appointments with your doctor.

Call your doctor if you continue to have symptoms.

Do not let anyone else take 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.

Brand Names

• Flovent® HFA