Fluticasone is a corticosteroid that works directly in the lungs to make breathing easier by reducing the swelling and inflammation of the airways. This medication must be used regularly to prevent the wheezing and shortness of breath caused by asthma, bronchitis, or some types of emphysema. It is recommended for use in adults and children 4 years of age and older.

This medication does not work immediately. Therefore, it is not used to relieve an acute asthma attack. If an asthma attack occurs, use your quick-relief inhaler (e.g., albuterol, salbutamol) as prescribed.

Read the Patient Information Leaflet which contains instructions for proper use of this medication. Consult your doctor or pharmacist if you have any questions.

Inhale this medication by mouth usually twice daily or as directed by your doctor. Dosage is based on your medical condition and response to therapy.

It is important to inhale each dose deeply since this will determine how much of the drug gets into your lungs. Do not breathe out (exhale) into the inhaler device.

If two inhalations are prescribed, wait at least one minute between them. If you are using other inhalers at the same time, wait several minutes between the use of each medication, and use this drug (the corticosteroid) last.

To prevent dry mouth, hoarseness and oral yeast infections from developing, gargle and rinse your mouth after each use. Do not swallow the rinse solution.

Use this medication regularly in order to get the most benefit from it. This medication works best if used consistently at even intervals. Remember to use it at the same times each day. Do not increase your dose, use this more frequently or stop using this medication without first consulting your doctor.

It may take up to 2 weeks or longer before the full benefit of this drug takes effect. Inform your doctor if your condition persists or worsens.

Dry or irritated throat, stuffy or runny nose, hoarseness, coughing, or diarrhea may occur as your body adjusts to this drug. A bad taste in the mouth may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: white patches in your mouth or on your tongue, persistent coughing, increased wheezing/trouble breathing.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: vision changes, increased thirst or urination, unusual or persistent headaches, chest pain or discomfort, numbness/tingling of the hands/feet, mental/mood changes (e.g., depression, agitation).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking fluticasone, tell your doctor or pharmacist if you are allergic to it; or have a severe allergy (anaphylaxis) to lactose or milk proteins (not lactose intolerance); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: tuberculosis, untreated or active infections, herpes infection of the eye, eye disease (glaucoma), decreased adrenal gland function, bone loss (osteoporosis).

If you have switched from an oral corticosteroid (e.g., prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses and suddenly stop using it, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids, especially if your body is stressed due to a major infection, surgery or injury. Deaths have sometimes occurred during such stresses, due to low steroid levels. Tell your doctor immediately if any of the following side effects occur: unusual weakness, sudden weight loss, dizziness. Consult your doctor or pharmacist for more details, and inform them that you use (or have used) any type of corticosteroid. Carry a warning card or medical ID bracelet that identifies your need for oral corticosteroids during times of stress as noted. Consult your doctor or pharmacist now for specific advice regarding stress situations; you may need to carry a supply of corticosteroid tablets as a precaution.

This medication may mask signs of infection or put you at greater risk of developing them. Report any signs of infection (e.g., persistent sore throat/fever/cough) that occur during treatment.

Avoid exposure to chickenpox or measles infection while taking this medication. If you are exposed to these infections, seek immediate medical attention.

Caution is advised when using this drug in children. Though it is unlikely to occur with inhaled steroids (fluticasone), this medication may temporarily slow down a child's rate of growth, but it will probably not affect final adult height. Monitor your child's height periodically.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: aldesleukin, natalizumab.

If you are currently using any of these medications, tell your doctor or pharmacist before starting fluticasone.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: oral corticosteroids (e.g., prednisone, dexamethasone), mifepristone, drugs affecting the removal of fluticasone from your system (potent CYP 3A4 inhibitors such as ketoconazole, ritonavir).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Do not share this medication with others.

Learn to use a peak flow meter. Use it daily and promptly report worsening asthma (such as readings in the yellow or red range, or increased use of quick-relief inhalers). Tell your doctor or pharmacist if you need to use 4 or more puffs daily for 2 or more consecutive days or more than 1 inhaler (200 puff canister) every 8 weeks of your quick-relief inhaler.

Make sure all of your doctors know that you are using this medication or have used it in the past.

Laboratory and/or medical tests (e.g., morning cortisol levels, lung function, eye exam, bone density tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that reduce the risk of bone loss include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store the US product at room temperature between 68-77 degrees F (20-25 degrees C)

Store the Canadian product between 36-86 degrees F (2-30 degrees C).

Store the medication away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised May 2009 Copyright(c) 2009 First DataBank, Inc.