Flovent HFA (Fluticasone Propionate Inhalation) - Indications and Dosage

INDICATIONS AND USAGE

FLOVENT HFA Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.

FLOVENT HFA Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

FLOVENT HFA should be administered by the orally inhaled route only in patients 4 years of age and older. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment.

After asthma stability has been achieved, it is always desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. The safety and efficacy of FLOVENT HFA when administered in excess of recommended dosages have not been established.

The recommended starting dosage and the highest recommended dosage of FLOVENT HFA, based on prior asthma therapy, are listed in Table 3.

Table 3. Recommended Dosages of FLOVENT HFA

NOTE: In all patients, it is desirable to titrate to the lowest effective dosage once asthma stability is achieved.

Previous Therapy	Recommended Starting Dosage	Highest Recommended Dosage
Adolescent and adult patients (≥12 years)
Bronchodilators alone	88 mcg twice daily	440 mcg twice daily
Inhaled corticosteroids	88-220 mcg twice daily*	440 mcg twice daily
Oral corticosteroids†	440 mcg twice daily	880 mcg twice daily
Pediatric patients (4 to 11 years)‡	88 mcg twice daily	88 mcg twice daily

^* For Patients Currently Receiving Inhaled Corticosteroid Therapy: Starting dosages above 88 mcg twice daily may be considered for patients with poorer asthma control or those who have previously required doses of inhaled corticosteroids that are in the higher range for that specific agent.

^† For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 to 5 mg/day on a weekly basis, beginning after at least 1 week of therapy with FLOVENT HFA. Patients should be carefully monitored for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency (see WARNINGS). Once prednisone reduction is complete, the dosage of fluticasone propionate HFA should be reduced to the lowest effective dosage.

^‡Recommended pediatric dosage is 88 mcg twice daily regardless of prior therapy.

FLOVENT HFA should be primed before using for the first time by releasing 4 test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 test spray into the air away from the face.

Geriatric Use

In studies where geriatric patients (65 years of age or older, see PRECAUTIONS: Geriatric Use) have been treated with fluticasone propionate inhalation aerosol, efficacy and safety did not differ from that in younger patients. Based on available data for FLOVENT HFA, no dosage adjustment is recommended.

Directions for Use

An Information for the Patient leaflet containing illustrated instructions for use accompany each package of FLOVENT HFA.

HOW SUPPLIED

FLOVENT HFA 44 mcg Inhalation Aerosol is supplied in 10.6-g pressurized aluminum canisters containing 120 metered actuations in boxes of 1 (NDC 0173-0718-20).

FLOVENT HFA 110 mcg Inhalation Aerosol is supplied in 12-g pressurized aluminum canisters containing 120 metered actuations in boxes of 1 (NDC 0173-0719-20).

FLOVENT HFA 220 mcg Inhalation Aerosol is supplied in 12-g pressurized aluminum canisters containing 120 metered actuations in boxes of 1 (NDC 0173-0720-20).

Each canister is fitted with a dose counter, supplied with a dark orange oral actuator with a peach strapcap, and sealed in a plastic coated, moisture protective foil pouch with a desiccant that should be discarded when the pouch is opened. Each canister is packaged with an Information for the Patient leaflet.

The dark orange actuator supplied with FLOVENT HFA should not be used with any other product canisters, and actuators from other products should not be used with a FLOVENT HFA canister.

The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000.

Keep out of reach of children. Avoid spraying in eyes.

Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw into fire or incinerator.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. SHAKE WELL FOR 5 SECONDS BEFORE USING.

FLOVENT HFA does not contain chlorofluorocarbons (CFCs) as the propellant.

DISKUS, FLOVENT, ROTADISK, and VENTOLIN are registered trademarks of GlaxoSmithKline.

AeroChamber Plus is a registered trademark and AeroChamber Z-STAT Plus is a trademark of Monaghan Medical Corp. or an affiliate of Monaghan Medical Corp.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2008, GlaxoSmithKline. All rights reserved.

July 2008 FLH:1PI

PHARMACIST — DETACH HERE AND GIVE LEAFLET TO PATIENT

Information for the Patient

FLOVENT ^® [flō′ vent] HFA 44 mcg

(fluticasone propionate 44 mcg)

Inhalation Aerosol

FLOVENT ^® HFA 110 mcg

(fluticasone propionate 110 mcg)

Inhalation Aerosol

FLOVENT ^® HFA 220 mcg

(fluticasone propionate 220 mcg)

Inhalation Aerosol

FOR ORAL INHALATION ONLY

Read this leaflet carefully before you start to use FLOVENT HFA Inhalation Aerosol.

Keep this leaflet because it has important summary information about FLOVENT HFA. This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about something, you should ask your doctor or pharmacist.

Read the new leaflet that comes with each refill of your prescription because there may be new information.

What is FLOVENT HFA?

FLOVENT HFA contains a medicine called fluticasone propionate, which is a synthetic corticosteroid. Corticosteroids are natural substances found in the body that help fight inflammation. Corticosteroids are used to treat asthma because they reduce airway inflammation.

FLOVENT HFA is used to treat asthma in patients 4 years of age and older. When inhaled regularly, FLOVENT HFA also helps to prevent symptoms of asthma.

FLOVENT HFA comes in 3 strengths. Your doctor has prescribed the one that is best for your condition.

Who should not use FLOVENT HFA?

Do not use FLOVENT HFA if you:

• are allergic to any of the ingredients in FLOVENT HFA or other inhaled corticosteroids. See “What are the ingredients in FLOVENT HFA?” below.

• have an acute asthma attack or status asthmaticus. FLOVENT HFA is not a bronchodilator and should not be used to give you fast relief from your breathing problems during an asthma attack. Always use a short-acting bronchodilator (rescue medicine), such as albuterol inhaler, during a sudden asthma attack. You must take FLOVENT HFA at regular times as recommended by your doctor, and not as an emergency medicine.

What should I tell my doctor before taking FLOVENT HFA?

Tell your doctor if you are:

• pregnant or planning to become pregnant. It is not known if FLOVENT HFA will harm your unborn baby.

• breastfeeding a baby. It is not known if FLOVENT HFA passes into your breast milk.

• exposed to chickenpox or measles.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. FLOVENT HFA may affect the way other medicines work, and other medicines may affect how FLOVENT HFA works. Especially, tell your doctor if you take:

• a medicine containing ritonavir (commonly used to treat HIV infection or AIDS). The anti-HIV medicines NORVIR^® (ritonavir capsules) Soft Gelatin, NORVIR (ritonavir oral solution), and KALETRA^® (lopinavir/ritonavir) Tablets contain ritonavir.

• any other corticosteroids.

How should I use FLOVENT HFA?

• It is important that you inhale each dose as your doctor has prescribed. The prescription label provided by your pharmacist will usually tell you what dose to take and how often. If it doesn’t, or if you are not sure, ask your doctor or pharmacist. DO NOT inhale more doses or use your FLOVENT HFA more often than your doctor has prescribed.

• It may take 1 to 2 weeks or longer for this medicine to work, and it is very important that you use it regularly. Do not stop taking FLOVENT HFA, even if you are feeling better, unless your doctor tells you to.

• If you miss a dose, just take your next scheduled dose when it is due. Do not double the dose.

• Your doctor may prescribe additional medicine (such as fast-acting bronchodilators) for emergency relief if a sudden asthma attack occurs. Contact your doctor if:

  an asthma attack does not respond to the additional medicine or

  • you need more of the additional medicine than usual.

• If you also use another medicine by inhalation, you should ask your doctor for instructions on when to use it while you are also using FLOVENT HFA.

What are the possible side effects of FLOVENT HFA?

Common side effects in adults and children using FLOVENT HFA include:

• a cold or upper respiratory tract infection

• throat irritation

• headache

• thrush (fungal infection) in the mouth and throat

Other common side effects in children include:

• fever

• diarrhea

• ear infection

• vomiting

• bronchitis

• inflammation of the nose and throat

• viral infection

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of FLOVENT HFA. For more information ask your doctor or pharmacist.

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

What are the ingredients in FLOVENT HFA?

Active ingredient: fluticasone propionate (micronized)

Inactive ingredient: propellant HFA-134a

Instructions for Using FLOVENT HFA

The parts of your FLOVENT HFA

There are 2 main parts to your FLOVENT HFA inhaler—the metal canister that holds the medicine and the dark orange plastic actuator that sprays the medicine from the canister (see Figure 1).

Figure 1

The canister has a counter to show how many sprays of medicine you have left. The number shows through a window in the back of the actuator. The counter starts at 124. The number will count down by 1 each time you spray the inhaler. The counter will stop counting at 000.

Never try to change the numbers or take the counter off the metal canister. The counter cannot be reset, and it is permanently attached to the canister.

The mouthpiece of the actuator is covered by a cap. A strap on this cap keeps it attached to the actuator.

Do not use the actuator with a canister of medicine from any other inhaler. And do not use a FLOVENT HFA canister with an actuator from any other inhaler.

Using your FLOVENT HFA

• The inhaler should be at room temperature before you use it.

• Take your FLOVENT HFA inhaler out of the moisture-protective foil pouch just before you use it for the first time. Safely throw away the foil pouch and the drying packet that comes inside the pouch.

• Priming the inhaler:

Before you use FLOVENT HFA for the first time, you must prime the inhaler so that you will get the right amount of medicine when you use it. To prime the inhaler, take the cap off the mouthpiece and shake the inhaler well for 5 seconds. Then spray the inhaler into the air away from your face. Avoid spraying in eyes. Shake and spray the inhaler like this 3 more times to finish priming it. The counter should now read 120.

You must prime the inhaler again if you have not used it in more than 7 days or if you drop it. Take the cap off the mouthpiece and shake the inhaler well for 5 seconds. Then spray it 1 time into the air away from your face.

• An adult should watch a child use the inhaler to be sure it is used correctly. If a child needs help using the inhaler, an adult should help the child use the inhaler with or without a holding chamber attached to a facemask. The adult should follow the instructions that came with the holding chamber.

Read the following 7 steps before using FLOVENT HFA and follow them at each use. If you have any questions, ask your doctor or pharmacist.

• Take the cap off the mouthpiece of the actuator (see Figure 2).

  Look inside the mouthpiece for foreign objects, and take out any you see.

  Make sure the canister fits firmly in the actuator.

  Shake the inhaler well for 5 seconds.

  
  Figure 2

• Hold the inhaler with the mouthpiece down (see Figure 2). Breathe out through your mouth and push as much air from your lungs as you can. Put the mouthpiece in your mouth and close your lips around it.

• Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth (see Figure 3).

  Right after the spray comes out, take your finger off the canister. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth.

  
  Figure 3

• Hold your breath as long as you can, up to 10 seconds. Then breathe normally.

• Wait about 30 seconds and shake the inhaler well for 5 seconds. Repeat steps 2 through 4.

• After you finish taking this medicine, rinse your mouth with water. Spit out the water. Do not swallow it.

• Put the cap back on the mouthpiece after each time you use the inhaler. Make sure it snaps firmly into place.

Cleaning your FLOVENT HFA

Clean the inhaler at least once a week after your evening dose. It is important to keep the canister and plastic actuator clean so the medicine will not build-up and block the spray.

• Take the cap off the mouthpiece. The strap on the cap will stay attached to the actuator. Do not take the canister out of the plastic actuator.

• Use a clean cotton swab dampened with water to clean the small circular opening where the medicine sprays out of the canister. Gently twist the swab in a circular motion to take off any medicine (see Figure 4). Repeat with a new swab dampened with water to take off any medicine still at the opening.

  
  Figure 4

• Wipe the inside of the mouthpiece with a clean tissue dampened with water. Let the actuator air-dry overnight.

• Put the cap back on the mouthpiece after the actuator has dried.

Storing your FLOVENT HFA

Store at room temperature with the mouthpiece down.

Keep out of reach of children.

Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw into fire or incinerator.

Replacing your FLOVENT HFA

• When the counter reads 020, you should refill your prescription or ask your doctor if you need a refill of your prescription.

• When the counter reads 000, throw the inhaler away. You should not keep using the inhaler because you will not receive the right amount of medicine.

• Do not use the inhaler after the expiration date, which is on the packaging it comes in.

For more information go to www.floventdiskus.com or call 1-888-825-5249.

FLOVENT is a registered trademark of GlaxoSmithKline.

NORVIR and KALETRA are registered trademarks of Abbott Laboratories.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2008, GlaxoSmithKline. All rights reserved.

July 2008 FLH:1PIL