AVAMYS (FLUTICASONE)

What is fluticasone propionate?

Fluticasone propionate (brand name: AVAMYS) is a glucocorticoid used most commonly as an inhaled treatment for asthma or other chronic respiratory diseases involving the trachea and bronchi (airways).

Its use in cats and dogs to treat airway disease is ‘off label’ or ‘extra label.’  Many drugs are commonly prescribed for off-label use in veterinary medicine. In these instances, follow your veterinarian’s directions and cautions very carefully, as their directions may differ significantly from those on the label.

Fluticasone nasal spray belongs to the class of medications called corticosteroids. It is used to treat seasonal and perennial (year-round) allergic rhinitis in people 2 years and older.

Fluticasone nasal spray helps to reduce the symptoms of seasonal allergic rhinitis such as stuffy, runny, or itchy nose; sneezing; and red, itchy, or watery eyes. This medication may start to work 8 to 24 hours after the first dose, but it may take several days to reach its full effect.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

For adults and adolescents 12 years of age and older, the recommended dose is 2 sprays in each nostril once daily, preferably at the same time each day. For the best results, this medication should be used regularly each day.

For children 2 to less than 12 years of age, the recommended starting dose is 1 spray in each nostril once daily. The doctor may suggest increasing the dose to 2 sprays in each nostril once daily until symptoms are controlled. Once the symptoms are under control, the doctor may suggest reducing the dose to 1 spray in each nostril once daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

If you are using this medication for the first time, if you have not used it for more than 30 days, or if the cap has been left off for more than 5 days, you will need to “prime” the pump by spraying the pump in the air (away from you) 6 times or until a fine mist is sprayed from the bottle. Before each use, gently blow your nose to clear your nostrils.

With the cap on, shake the medication well. Then remove the cap and follow these 3 steps to use the medication:

• Tilt your head forward slightly and place the nozzle in one of your nostrils. Point the end of the nozzle towards the side of your nose.
• Press the button firmly one time to spray the medication while you are breathing in through your nose. Remove the nozzle from your nose and breathe out through your mouth.
• Repeat steps 1 and 2 for the other nostril.

If you are using 2 sprays in each nostril, repeat steps 1 to 3 again.

Avoid getting the spray in your eyes. If you do, thoroughly rinse your eyes with water. Always put the cap back on after use.

The contents of the bottle can be viewed through an indicator window. The nasal device should be discarded after the labelled number of sprays has been used. Beyond this, the correct amount of medication in each spray cannot be assured, even though the bottle is not completely empty.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose of this medication by several hours, skip the missed dose and continue with your regular dosing schedule. Do not double a dose to make up for a missed dose. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature in an upright position with the cap on, and keep it out of the reach of children. Do not refrigerate or freeze it.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Fluticasone furoate nasal spray is an unscented, taste-free, alcohol-free, preserved aqueous suspension of micronized fluticasone furoate for topical administration to the nasal mucosa by means of a metering (50 µL), atomizing spray pump. Each bottle contains a net fill weight of 4.5 g or 10 g and will provide 30 or 120 metered sprays, respectively, after the initial priming. Each spray delivers a fine mist containing 27.5 µg of fluticasone furoate in 50 µL of the formulation. Nonmedicinal ingredients: 0.015% w/w benzalkonium chloride, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium, microcrystalline cellulose, polysorbate 80, and purified water.

Who should NOT take this medication?

Fluticasone furoate nasal spray should not be used by anyone who is allergic to fluticasone furoate or to any of the ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is used in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back pain
• cough
• dizziness
• fever
• headache
• nausea
• nose irritation or pain
• nosebleeds
• sore throat
• stuffy nose

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• feeling that your heart is racing
• high blood pressure (e.g., headaches, vision changes, nausea, vomiting)
• increased frequency of infection; cold or flu-like symptoms
• nasal septum perforation (small holes in the wall between the nostrils)
• shortness of breath
• slowed growth in children and adolescents
• sores or ulcers inside the nose
• symptoms of decreased adrenal function (e.g., tiredness, weakness, nausea, vomiting, low blood pressure)
• symptoms of a fungal infection in the nose (e.g., nasal discharge, fever, headache, fatigue, generally not feeling well)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of too much corticosteroid (e.g., weight gain especially around the body and face, “moon face”, sweating, thinning of the skin, bruising easily, muscle and bone weakness)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Growth in children and adolescents: Corticosteroids such as fluticasone furoate nasal spray may impair the growth of children and adolescents. Your doctor will monitor for this. Talk to your doctor if you have any concerns.

Infections: Corticosteroids such as fluticasone furoate nasal spray may worsen existing infections, mask the signs of infection, and cause new infections. If you use this medication for several months or longer, your doctor will monitor you periodically for signs of infection. People who have not had chickenpox or measles or have not been vaccinated against these infections should take special care to avoid exposure to them.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Other corticosteroid medications: People who have been taking oral corticosteroids and are starting fluticasone furoate should be carefully monitored by their doctor. Changing from the oral form to the nasal spray can cause symptoms such as tiredness, aches, pains, and depression. Tell your doctor if you have used or are using other corticosteroids. Your doctor will monitor you while you are taking this medication.

Vision problems: Corticosteroids such as fluticasone furoate nasal spray may cause glaucoma or cataracts. Report any vision changes to your doctor immediately. If you have glaucoma or cataracts, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Wound healing: Corticosteroids such as fluticasone furoate nasal spray can impair the ability of wounds to heal. If you have ulcers in your nose, have had nasal surgery, or have had nasal trauma, talk to your doctor about how this medication will affect these conditions. Your doctor may recommend waiting until wounds have completely healed.

Pregnancy: The safety of fluticasone furoate nasal spray use during pregnancy has not been established. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if fluticasone furoate nasal spray passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children under the age of 2 years.

What other drugs could interact with this medication?

There may be an interaction between fluticasone furoate nasal spray and any of the following:

• “azole” antifungals (e.g., ketoconzole, itraconazole, voriconazole)
• ceritinib
• cobicistat
• delavirdine
• desmopressin
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir, tipranavir)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• idelalisib

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.