Fluticasone Furoate

Fluticasone furoate is a prescription medication used to prevent symptoms of asthma. Fluticasone furoate can also treat the symptoms of allergic and non-allergic rhinitis. Fluticasone furoate is in a class of medications called corticosteroids. These works by decreasing swelling and irritation in the airways to allow for easier breathing.

Fluticasone furoate for oral inhalation is typically used once daily to prevent asthma-related symptoms. Fluticasone furoate intranasal spray is sprayed into each nostril once daily to treat symptoms of allergic rhinitis.

Common side effects of fluticasone furoate for inhalation include upper airway infection or inflammation, throat irritation, and cough. Common side effects of fluticasone furoate for intranasal administration include headache, nose bleeds, throat pain, and nasal burning or irritation.

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

Fluticasone furoate is a prescription medication used to prevent symptoms of asthma, including difficulty breathing, chest tightness, wheezing, and coughing, in adults and children aged 12 years and older. Fluticasone furoate can also treat the symptoms of allergic and non-allergic rhinitis, including sneezing and runny, stuffy, and itchy nose, in patients aged 2 years and older.

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

Fluticasone Furoate may be found in some form under the following brand names:

• Arnuity Ellipta

• Breo Ellipta

• Veramyst

Inhalational:

Common side effects of fluticasone furoate for inhalation include

• upper airway infection or inflammation
• throat irritation
• sinus infection
• hoarse voice
• candidiasis
• cough
• headache

Topical:

Common side effects of fluticasone furoate nasal spray include

• headache
• nosebleeds
• irritated or burning nose
• runny nose
• cough
• nausea
• stomach pain
• vomiting
• diarrhea
• dizziness

This is not a complete list of fluticasone furoate side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that stop the work of an enzyme in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)

This is not a complete list of fluticasone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with fluticasone furoate 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 furoate 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 furoate nasal spray can cause dizziness. Do not drive or operate machinery until you know how fluticasone furoate 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 furoate nasal spray if you:

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

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 furoate, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking fluticasone furoate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to fluticasone furoate or to any of its ingredients
• are exposed to measles or chickenpox
• are allergic to fluticasone nasal spray
• have liver problems
• take ritonavir (Norvir)
• take any other corticosteroids such as hydrocortisone
• have an autoimmune disease such as HIV/AIDS
• have an infection
• have an allergy to formaldehyde
• have a history of glaucoma or cataracts
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fluticasone furoate falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if fluticasone furoate crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using fluticasone furoate.

Inhalational:

Take fluticasone furoate exactly as prescribed.

Fluticasone furoate comes in oral inhalational form and is taken once a day. It may take up to 2 weeks for fluticasone furoate to reach its full effectiveness.

If you miss a dose by several hours, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluticasone furoate at the same time.

Topical:

Take fluticasone furoate exactly as prescribed.

Fluticasone furoate comes in the form of a nasal spray and is taken once a day.

If you miss a dose by several hours, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluticasone furoate at the same time.

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 fluticasone furoate oral inhalation for the prevention of asthma symptoms is 1 inhalation (containing 100 mcg) of fluticasone furoate every 24 hours. If symptoms are not controlled at this dose, the dose may be increased to 1 inhalation (containing 200 mcg) every 24 hours.

Topical:

The recommended dose of fluticasone furoate oral inhalation for the treatment of allergic rhinitis symptoms is 2 sprays per nostril (for a total of 110 mcg) of fluticasone furoate 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 55 mcg) every 24 hours.

If you take too much fluticasone furoate, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If fluticasone furoate is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

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