Fluticasone Propionate

Name: Fluticasone Propionate

Patient information

ADVAIR DISKUS®
[ad'vair disk' us] 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)

ADVAIR DISKUS® 250/50
(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)

ADVAIR DISKUS® 500/50
(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder) for oral inhalation

What is the most important information I should know about ADVAIR DISKUS?

ADVAIR DISKUS can cause serious side effects, including:

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, reduces the risk of death from asthma problems seen with LABA medicines.
  • It is not known if LABA medicines such as salmeterol increase the risk of death in people with COPD.
  • Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS. You may need different treatment.
  • Get emergency medical care if:
    • your breathing problems worsen quickly
    • you use your rescue inhaler, but it does not relieve your breathing problems
  • ADVAIR DISKUS should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid. W hen your asthma is well controlled, your healthcare provider may tell you to stop taking ADVAIR DISKUS. Your healthcare provider will decide if you can stop ADVAIR DISKUS without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid.
  • Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

What is ADVAIR DISKUS?

  • ADVAIR DISKUS combines the inhaled corticosteroid (ICS) medicine fluticasone propionate and the LABA medicine salmeterol.
  • ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
  • LABA medicines such as salmeterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
  • ADVAIR DISKUS is not used to relieve sudden breathing problems.
  • It is not known if ADVAIR DISKUS is safe and effective in children younger than 4 years.
  • ADVAIR DISKUS is used for asthma and COPD as follows:

Asthma:

  • ADVAIR DISKUS is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in adults and children aged 4 years and older.
  • ADVAIR DISKUS contains salmeterol [the same medicine found in SEREVENT® DISKUS® (salmeterol xinafoate inhalation powder)]. LABA medicines such as salmeterol increase the risk of death from asthma problems.
  • ADVAIR DISKUS is not for adults and children with asthma who are well controlled with an asthma control medicine, such as a low to medium dose of an inhaled corticosteroid medicine.

COPD:

ADVAIR DISKUS 250/50 is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. ADVAIR DISKUS 250/50 is used long term as 1 inhalation 2 times each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

Who should not use ADVAIR DISKUS?

Do not use ADVAIR DISKUS if you:

  • have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
  • are allergic to fluticasone propionate, salmeterol, or any of the ingredients in ADVAIR DISKUS. See “What are the ingredients in ADVAIR DISKUS?” below for a complete list of ingredients.

What should I tell my healthcare provider before using ADVAIR DISKUS?

Tell your healthcare provider about all of your health conditions, including if you:

  • have heart problems
  • have high blood pressure
  • have seizures
  • have thyroid problems
  • have diabetes
  • have liver problems
  • have weak bones (osteoporosis)
  • have an immune system problem
  • have eye problems such as glaucoma or cataracts
  • are allergic to any of the ingredients in ADVAIR DISKUS, any other medicines, or food products. See “What are the ingredients in ADVAIR DISKUS?” below for a complete list of ingredients.
  • have any type of viral, bacterial, or fungal infection
  • are exposed to chickenpox or measles
  • have any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if ADVAIR DISKUS may harm your unborn baby.
  • are breastfeeding. It is not known if the medicines in ADVAIR DISKUS pass into your milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADVAIR DISKUS and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use ADVAIR DISKUS?

Read the step-by-step instructions for using ADVAIR DISKUS at the end of this Medication Guide.

What should I avoid while using ADVAIR DISKUS?

  • Do not use ADVAIR DISKUS unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Children should use ADVAIR DISKUS with an adult's help, as instructed by the child's healthcare provider.
  • ADVAIR DISKUS comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
  • Use ADVAIR DISKUS exactly as your healthcare provider tells you to use it. Do not use ADVAIR DISKUS more often than prescribed.
  • Use 1 inhalation of ADVAIR DISKUS 2 times each day. Use ADVAIR DISKUS at the same time each day, about 12 hours apart.
  • If you miss a dose of ADVAIR DISKUS, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • If you take too much ADVAIR DISKUS, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
  • Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
  • Do not stop using ADVAIR DISKUS unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
  • ADVAIR DISKUS does not relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse
    • you need to use your rescue inhaler more often than usual
    • your rescue inhaler does not work as well to relieve your symptoms
    • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row
    • you use 1 whole canister of your rescue inhaler in 8 weeks
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
    • you have asthma and your symptoms do not improve after using ADVAIR DISKUS regularly for 1 week.

What are the possible side effects of ADVAIR DISKUS?

ADVAIR DISKUS can cause serious side effects, including:

  • See “What is the most important information I should know about ADVAIR DISKUS?”
  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ADVAIR DISKUS to help reduce your chance of getting thrush.
  • pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:
    • increase in mucus (sputum) production
    • chills
    • change in mucus color
    • increased cough
    • fever
    • increased breathing problems
  • weakened immune system and increased chance of getting infections (immunosuppression)
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as ADVAIR DISKUS). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
    • feeling tired
    • nausea and vomiting
    • lack of energy
    • low blood pressure
    • weakness
  • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using ADVAIR DISKUS and call your healthcare provider right away.
  • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • swelling of your face, mouth, and tongue
    • hives
    • breathing problems
  • effects on heart
    • increased blood pressure
    • chest pain
    • a fast or irregular heartbeat
  • effects on nervous system
    • tremor
    • nervousness
  • bone thinning or weakness (osteoporosis)
  • slowed growth in children. A child's growth should be checked often.
  • eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS.
  • changes in laboratory blood values (sugar, potassium, certain types of white blood cells)

Common side effects of ADVAIR DISKUS include:

Asthma:

  • upper respiratory tract infection
  • bronchitis
  • throat irritation
  • cough
  • hoarseness and voice changes
  • headache
  • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
  • nausea and vomiting

In children with asthma, infections in the ear, nose, and throat are common.

COPD:

  • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
  • viral respiratory infections
  • headache
  • throat irritation
  • hoarseness and voice changes
  • muscle and bone pain

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with ADVAIR DISKUS. Ask your healthcare provider or pharmacist for more information.

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

How should I store ADVAIR DISKUS?

  • Store ADVAIR DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
  • Store ADVAIR DISKUS in the unopened foil pouch and only open when ready for use.
  • Safely throw away ADVAIR DISKUS in the trash 1 month after you open the foil pouch or when the counter reads 0, whichever comes first.
  • Keep ADVAIR DISKUS and all medicines out of the reach of children.

General information about the safe and effective use of ADVAIR DISKUS.

Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use ADVAIR DISKUS for a condition for which it was not prescribed. Do not give your ADVAIR DISKUS to other people, even if they have the same condition that you have. It may harm them.

This Medication Guide summarizes the most important information about ADVAIR DISKUS. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about ADVAIR DISKUS that was written for healthcare professionals.

What are the ingredients in ADVAIR DISKUS?

Active ingredients: fluticasone propionate, salmeterol xinafoate

Inactive ingredients: lactose monohydrate (contains milk proteins)

For more information about ADVAIR DISKUS, call 1-888-825-5249 or visit our website at www.advair.com.

INSTRUCTIONS FOR USE

ADVAIR DISKUS®
[ad'vair disk' us] 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)

ADVAIR DISKUS® 250/50
(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)

ADVAIR DISKUS® 500/50
(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder) for oral inhalation

Read this Instructions for Use before you start using ADVAIR DISKUS and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Your ADVAIR DISKUS inhaler

Figure A

Important information about your ADVAIR DISKUS inhaler:

  • ADVAIR DISKUS is for oral inhalation use only.
  • Take ADVAIR DISKUS out of the foil pouch just before you use it for the first time. Safely throw away the pouch. The DISKUS® will be in the closed position.
  • Write the date you opened the foil pouch in the first blank line on the label. See Figure A.
  • Write the “use by” date in the second blank line on the label. See Figure A. That date is 1 month after the date you wrote in the first line.
  • The counter should read 60. If you have a sample (with “Sample” on the back label) or institutional (with “INSTITUTIONAL PACK” on the foil pouch) pack, the counter should read 14.

How to use your ADVAIR DISKUS inhaler

Follow these steps every time you use ADVAIR DISKUS.

Step 1. Open your ADVAIR DISKUS.

  • Hold the DISKUS 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. See Figure B.

Step 2. Slide the lever until you hear it click.

  • Hold the DISKUS in a level, flat position with the mouthpiece towards you. Slide the lever away from the mouthpiece as far as it will go until it clicks. See Figure C.

Figure B and C

  • The number on the counter will count down by 1. The DISKUS is now ready to use.

Follow the instructions below so you will not accidentally waste a dose:

  • Do not close the DISKUS.
  • Do not tilt the DISKUS.
  • Do not move the lever on the DISKUS.

Step 3. Inhale your medicine.

  • Before you breathe in your dose from the DISKUS, breathe out (exhale) as long as you can while you hold the DISKUS level and away from your mouth. See Figure D. Do not breathe into the mouthpiece.
  • Put the mouthpiece to your lips. See Figure E. Breathe in quickly and deeply through the DISKUS. Do not breathe in through your nose.

Figure D and E

  • Remove the DISKUS from your mouth and hold your breath for about 10 seconds, or for as long as is comfortable for you.
  • Breathe out slowly as long as you can. See Figure D.
  • The DISKUS delivers your dose of medicine as a very fine powder that you may or may not taste or feel. Do not take an extra dose from the DISKUS even if you do not taste or feel the medicine.

Step 4. Close the DISKUS.

  • Place your thumb in the thumb grip and slide it back towards you as far as it will go. See Figure F. Make sure the DISKUS clicks shut and you cannot see the mouthpiece.

Figure F

  • The DISKUS is now ready for you to take your next scheduled dose in about 12 hours.

When you are ready to take your next dose, repeat Steps 1 through 4.

Step 5. Rinse your mouth.

  • Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it. See Figure G.

Figure G

When should you get a refill?

The counter on top of the DISKUS shows you how many doses are left. After you have taken 55 doses (9 doses from the sample or institutional pack), the numbers 5 to 0 will show in red. See Figure H. These numbers warn you there are only a few doses left and are a reminder to get a refill.

Figure H

For correct use of the DISKUS, remember:

  • Always use the DISKUS in a level, flat position.
  • Make sure the lever firmly clicks into place.
  • Hold your breath for about 10 seconds after inhaling. Then breathe out fully.
  • After each dose, rinse your mouth with water and spit it out. Do not swallow the water.
  • Do not take an extra dose, even if you did not taste or feel the powder.
  • Do not take the DISKUS apart.
  • Do not wash the DISKUS.
  • Always keep the DISKUS in a dry place.
  • Do not use the DISKUS with a spacer device.

If you have questions about ADVAIR DISKUS or how to use your inhaler, call GlaxoSmithKline (GSK) at 1-888-825-5249 or visit www.advair.com.

Overdose

Chronic overdosage may result in signs/symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. Inhalation by healthy volunteers of a single dose of 4,000 mcg of fluticasone propionate inhalation powder or single doses of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in subjects were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.

Fluticasone Propionate Precautions

Serious side effects have been reported with fluticasone propionate including the following:

Inhalational:

  • fungal infections (thrush) in your mouth and throat. Tell your doctor if you have any redness or white-colored coating in your mouth
  • decreased adrenal function (adrenal insufficiency). Symptoms of decreased adrenal function include tiredness, weakness, nausea and vomiting, and low blood pressure. Decreased adrenal function can lead to death.
  • allergic reaction (anaphylaxis). Call your doctor and stop fluticasone right away if you have any symptoms of an allergic reaction:
  • swelling of the face, throat and tongue
  • hives
  • rash
  • breathing problems
  • decreased ability to fight infections. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection while you use fluticasone.
  • slow growth in children. The growth of children using fluticasone should be checked regularly.
  • eye problems including glaucoma and cataracts. Tell your doctor about any vision changes while using fluticasone. Your doctor may tell you to have your eyes checked.
  • increased wheezing (bronchospasm). Increased wheezing can happen right away after using fluticasone. Always have a rescue inhaler with you to treat sudden wheezing.
  • lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).

Topical:

  • decreased ability to fight infections. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection while you use fluticasone.
  • slow growth in children. The growth of children using fluticasone should be checked regularly.
  • eye problems including glaucoma and cataracts. Tell your doctor about any vision changes while using fluticasone. Your doctor may tell you to have your eyes checked.
  • slow wound healing. Do not use fluticasone propionate nasal spray until your nose has healed if you have a sore in your nose, if you have surgery on your nose, or if your nose has been injured.
  • allergic reaction (anaphylaxis). Call your doctor and stop fluticasone right away if you have any symptoms of an allergic reaction:
  • swelling of the face, throat and tongue
  • hives
  • rash
  • breathing problems

Fluticasone propionate nasal spray can cause dizziness. Do not drive or operate machinery until you know how fluticasone propionate nasal spray affects you.

To avoid withdrawal side effects, do not stop taking fluticasone nasal spray at once. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether.

Do not take fluticasone propionate nasal spray if you:

  • are allergic to fluticasone propionate nasal spray or any of its ingredients
  • are taking ritonavir (Norvir)

Fluticasone Propionate Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of fluticasone propionate, there are no specific foods that you must exclude from your diet when receiving this medication.

Fluticasone Propionate Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

  • The dose your doctor recommends may be based on the following:
  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your age

Inhalational:

The recommended adult dose of FLOVENT DISKUS (fluticasone propionate powder for oral inhalation) for the prevention of asthma symptoms is 100 to 1000 mcg of fluticasone propionate twice daily, depending on previous treatment with corticosteroids. The recommended adult dose of FLOVENT HFA (fluticasone propionate aerosol for oral inhalation) for the prevention of asthma symptoms is 88 to 440 mcg of fluticasone propionate twice daily, depending on previous treatment with corticosteroids.

Topical:

The recommended adult dose of fluticasone propionate nasal spray for the treatment of allergic rhinitis symptoms is 2 sprays per nostril (for a total of 200 mcg) of fluticasone propionate every 24 hours. Once symptoms are controlled at this dose, the dose may be decreased to 1 spray per nostril (for a total dose of 100 mcg) every 24 hours.

The recommended dose of fluticasone propionate cream, lotion, and ointment for the relief of skin swelling and redness is application to the affected area once or twice daily until control is achieved.

Other Requirements

  • Store fluticasone propionate at room temperature.
  • Keep this and all medicines out of the reach of children.

What is fluticasone inhalation (flovent diskus, flovent hfa)?

Fluticasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Fluticasone inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Fluticasone may also be used for purposes not listed in this medication guide.

What is the most important information i should know about fluticasone inhalation (flovent diskus, flovent hfa)?

Do not use fluticasone inhalation to treat an asthma attack that has already begun.

Before using this medication, tell your doctor if you have been sick or had an infection of any kind. You may not be able to use fluticasone inhalation until you are well.

Contact your doctor if your asthma symptoms do not improve after using fluticasone inhalation for 2 weeks.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you were switched from an oral (taken by mouth) steroid to fluticasone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

What happens if i miss a dose (flovent diskus, flovent hfa)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Side effects

Systemic and local corticosteroid use may result in the following:

  • Candida albicans infection [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression [see WARNINGS AND PRECAUTIONS]
  • Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
  • Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]
  • Growth effects [see WARNINGS AND PRECAUTIONS]
  • Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidence of common adverse reactions in Table 1 is based upon 7 placebo-controlled U.S. clinical trials in which 1,176 pediatric, adolescent, and adult subjects (466 females and 710 males) previously treated with as-needed bronchodilators and/or inhaled corticosteroids were treated twice daily for up to 12 weeks with FLOVENT DISKUS (doses of 50 to 500 mcg) or placebo.

Table 1. Adverse Reactions with FLOVENT DISKUS with >3% Incidence and More Common than Placebo in Subjects with Asthma

Adverse Event FLOVENT DISKUS
50 mcg Twice Daily
(n = 178)
%
FLOVENT DISKUS
100 mcg Twice Daily
(n = 305)
%
FLOVENT DISKUS
250 mcg Twice Daily
(n = 86)
%
FLOVENT DISKUS
500 mcg Twice Daily
(n = 64)
%
Placebo
(n = 543) %
Ear, nose, and throat
  Upper respiratory tract infection 20 18 21 14 16
  Throat irritation 13 13 3 22 8
  Sinusitis/sinus infection 9 10 6 6 6
  Upper respiratory inflammation 5 5 0 5 3
  Rhinitis 4 3 1 2 2
  Oral candidiasis <1 9 6 5 7
Gastrointestinal
  Nausea and vomiting 8 4 1 2 4
  Gastrointestinal discomfort and pain 4 3 2 2 3
  Viral gastrointestinal infection 4 3 3 5 1
Non-site specific
  Fever 7 7 1 2 4
  Viral infection 2 2 0 5 2
Lower respiratory
  Viral respiratory infection 4 5 1 2 4
  Cough 3 5 1 5 4
  Bronchitis 2 3 0 8 1
Neurological
  Headache 12 12 2 14 7
Musculoskeletal and trauma
  Muscle injury 2 0 1 5 1
  Musculoskeletal pain 4 3 2 5 2
  Injury 2 <1 0 5 <1

Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in any of the groups treated with FLOVENT DISKUS and were more common than in the placebo group. Less than 2% of subjects discontinued from the trials because of adverse reactions. The average duration of exposure was 73 to 79 days in the active treatment groups compared with 56 days in the placebo group.

Additional Adverse Reactions

Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction; fluid disturbances; weight gain; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.

Three (3) of the 7 placebo-controlled U.S. clinical trials were pediatric trials. A total of 592 subjects aged 4 to 11 years were treated with FLOVENT DISKUS (dosages of 50 or 100 mcg twice daily) or placebo; an additional 174 subjects aged 4 to 11 years received FLOVENT ROTADISK (fluticasone propionate inhalation powder) at the same doses. There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.

In the first 16 weeks of a 52-week clinical trial in adult subjects with asthma who previously required oral corticosteroids (daily doses of 5 to 40 mg oral prednisone), the effects of FLOVENT DISKUS 500 mcg twice daily (n = 41) and 1,000 mcg twice daily (n = 36) were compared with placebo (n = 34) for the frequency of reported adverse events. The average duration of exposure for subjects taking FLOVENT DISKUS was 105 days compared with 75 days for placebo. Adverse events, whether or not considered drug related by the investigators, reported in more than 5 subjects in the group taking FLOVENT DISKUS and that occurred more frequently with FLOVENT DISKUS than with placebo are shown below (percent FLOVENT DISKUS and percent placebo).

Ear, Nose, and Throat: Hoarseness/dysphonia (9% and 0%), nasal congestion/blockage (16% and 0%), oral candidiasis (31% and 21%), rhinitis (13% and 9%), sinusitis/sinus infection (33% and 12%), throat irritation (10% and 9%), and upper respiratory tract infection (31% and 24%).

Gastrointestinal: Nausea and vomiting (9% and 0%).

Lower Respiratory: Cough (9% and 3%) and viral respiratory infections (9% and 6%).

Musculoskeletal: Arthralgia and articular rheumatism (17% and 3%) and muscle pain (12% and 0%).

Non-Site Specific: Malaise and fatigue (16% and 9%) and pain (10% and 3%).

Skin: Pruritus (6% and 0%) and skin rashes (8% and 3%).

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of fluticasone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

Ear, Nose, And Throat

Aphonia, facial and oropharyngeal edema, and throat soreness. Endocrine and Metabolic Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, and osteoporosis. Eye Cataracts.

Immune System Disorders

Immediate and delayed hypersensitivity reactions, including anaphylaxis, rash, angioedema, and bronchospasm, have been reported. Anaphylactic reactions in patients with severe milk protein allergy have been reported.

Infections And Infestations

Esophageal candidiasis.

Psychiatry

Agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Respiratory

Asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, and wheeze.

Skin

Contusions and ecchymoses.

Read the entire FDA prescribing information for Flovent Diskus (Fluticasone Propionate)

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