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Flovent

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Flovent

INDICATIONS

FLOVENT (fluticasone propionate) Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy. 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 (fluticasone propionate) Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

FLOVENT (fluticasone propionate) Inhalation Aerosol should be administered by the orally inhaled route in patients 12 years of age and older. Individual patients will experience a variable time to onset and degree of symptom relief. Generally, FLOVENT (fluticasone propionate) Inhalation Aerosol has a relatively rapid onset of action for an inhaled glucocorticoid. Improvement in asthma control following inhaled administration of fluticasone propionate can occur within 24 hours of beginning treatment, although maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment.

After asthma stability has been achieved (see Table 2), 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 (fluticasone propionate) Inhalation Aerosol when administered in excess of recommended dosages have not been established.

The recommended starting dosage and the highest recommended dosage of FLOVENT (fluticasone propionate) Inhalation Aerosol, based on prior antiasthma therapy, are listed in Table 2.

Table 2. Recommended Dosages of FLOVENT Inhalation Aerosol

Previous Therapy Dosage

Recommended Starting

Highest Recommended Dosage

Bronchodilators alone

88 mcg twice daily

440 mcg twice daily

Inhaled corticosteroids

88-220 mcg twice daily*

440 mcg twice daily

Oral corticosteroids

880 mcg twice daily

880 mcg twice daily

* 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.

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

For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with FLOVENT Inhalation Aerosol. 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 should be reduced to the lowest effective dosage.

Geriatric Use

In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with FLOVENT (fluticasone propionate) Inhalation Aerosol, efficacy and safety did not differ from that in younger patients. Consequently, no dosage adjustment is recommended. Directions for Use

Illustrated Patient’s Instructions for Use accompany each package of FLOVENT (fluticasone propionate) Inhalation Aerosol.

HOW SUPPLIED

FLOVENT (fluticasone propionate) 44 mcg Inhalation Aerosol is supplied in 7.9-g canisters containing 60 metered inhalations in institutional pack boxes of 1 (NDC 0173-0497-00) and in 13-g canisters containing 120 metered inhalations in boxes of 1 (NDC 0173-0491-00). Each canister is supplied with a dark orange oral actuator with a peach strapcap and patient s instructions. Each actuation of the inhaler delivers 44 mcg of fluticasone propionate from the actuator.

FLOVENT (fluticasone propionate) 110 mcg Inhalation Aerosol is supplied in 7.9-g canisters containing 60 metered inhalations in institutional pack boxes of 1 (NDC 0173-0498-00) and in 13-g canisters containing 120 metered inhalations in boxes of 1 (NDC 0173-0494-00). Each canister is supplied with a dark orange oral actuator with a peach strapcap and patient s instructions. Each actuation of the inhaler delivers 110 mcg of fluticasone propionate from the actuator.

FLOVENT (fluticasone propionate) 220 mcg Inhalation Aerosol is supplied in 7.9-g canisters containing 60 metered inhalations in institutional pack boxes of 1 (NDC 0173-0499-00) and in 13-g canisters containing 120 metered inhalations in boxes of 1 (NDC 0173-0495-00). Each canister is supplied with a dark orange oral actuator with a peach strapcap and patient s instructions. Each actuation of the inhaler delivers 220 mcg of fluticasone propionate from the actuator.

FLOVENT (fluticasone propionate) canisters are for use with FLOVENT (fluticasone propionate) Inhalation Aerosol actuators only. The actuators should not be used with other aerosol medications.

The correct amount of medication in each inhalation cannot be assured after 60 inhalations from the 7.9-g canister or 120 inhalations from the 13-g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations has been used.

Store between 2° and 30°C (36° and 86°F). Store canister with mouthpiece down. Protect from freezing temperatures and direct sunlight.

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F. Keep out of reach of children. For best results, the canister should be at room temperature before use. Shake well before using.

Note

The indented statement below is required by the Federal Government s Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs).

Warning

Contains trichlorofluoromethane and dichlorodifluoromethane, substances that harm public health and environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the patient information leaflet of this product pursuant to EPA regulations.

GlaxoSmithKline, Research Triangle Park, NC 27709, ©2004, GlaxoSmithKline. All rights reserved. March 2004 RL-2067

Last reviewed on RxList: 12/30/2004
This monograph has been modified to include the generic and brand name in many instances.

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