Flovent HFA

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Indications & Dosage

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INDICATIONS

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 Inhaled corticosteroids Oral corticosteroids^†	88 mcg twice daily88-220 mcg twice daily* 440 mcg twice daily	440 mcg twice daily 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. June 2008. FDA rev date: 07/01/08

Brand Name: Flovent HFA
Generic Name: Fluticasone Propionate HFA

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