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FLOVENT DISKUS (fluticasone propionate) is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric 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 DISKUS (fluticasone propionate) is NOT indicated for the relief of acute bronchospasm.
DOSAGE AND ADMINISTRATION
FLOVENT DISKUS (fluticasone propionate) 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 DISKUS (fluticasone propionate) when administered in excess of recommended dosages have not been established.
The recommended starting dosage and the highest recommended dosage of FLOVENT DISKUS (fluticasone propionate) , based on prior asthma therapy, are listed in Table 2.
Table 2. Recommended Dosages of FLOVENT DISKUS (fluticasone propionate) *
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|
|Adults and Adolescents|
|Bronchodilators alone||100 mcg twice daily||500 mcg twice daily|
|Inhaled corticosteroids||100-250 mcg twice daily||500 mcg twice daily|
|Oral corticosteroids†||500-1,000 mcg twice daily‡||1,000 mcg twice daily|
|Children 4 to 11 Years|
|Bronchodilators alone||50 mcg twice daily||100 mcg twice daily|
|Inhaled corticosteroids||50 mcg twice daily||100 mcg twice daily|
|* Starting dosages above 100 mcg twice daily for adults and
adolescents and 50 mcg twice daily for children 4 to 11 years of age 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 mg/day on a weekly basis, beginning after at least 1 week of therapy with FLOVENT DISKUS. 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.
‡ The choice of starting dosage should be made on the basis of individual patient assessment. A controlled clinical study of 111 oral corticosteroid-dependent patients with asthma showed few significant differences between the 2 doses of FLOVENT DISKUS (fluticasone propionate) on safety and efficacy endpoints. However, inability to decrease the dose of oral corticosteroids further during corticosteroid reduction may be indicative of the need to increase the dose of fluticasone propionate up to the maximum of 1,000 mcg twice daily.
Pediatric Use: Because individual responses may vary, children previously maintained on other inhaled corticosteroids may require dosage adjustments upon transfer to FLOVENT DISKUS (fluticasone propionate) .
Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS: Geriatric Use) have been treated with fluticasone propionate inhalation powder, efficacy and safety did not differ from that in younger patients. Based on available data for FLOVENT DISKUS (fluticasone propionate) , no dosage adjustment is recommended.
Directions for Use: Illustrated Patient's Instructions for Use accompany each package of FLOVENT DISKUS (fluticasone propionate) .
FLOVENT DISKUS (fluticasone propionate) 50 mcg (NDC 0173-0600-02), FLOVENT DISKUS (fluticasone propionate) 100 mcg (NDC 0173-0602-02), and FLOVENT DISKUS (fluticasone propionate) 250 mcg (NDC 0173-0601-02) are each supplied as a disposable orange inhalation unit containing 60 blisters of powder formulation packaged in an orange, plastic-coated, moisture-protective foil pouch in a carton of 1.
Store at controlled room temperature (see USP), 20° to 25°C (68° to 77°F) in a dry place away from direct heat or sunlight. Keep out of reach of children. The DISKUS inhalation device is not reusable. FLOVENT DISKUS (fluticasone propionate) should be discarded 6 weeks (50-mcg strength) or 2 months (100- and 250-mcg strengths) after removal from the moisture-protective foil pouch or after all blisters have been used (when the dose indicator reads “0”), whichever comes first. Do not attempt to take the device apart.
GlaxoSmithKline Research Triangle Park, NC 27709. July 2008
Last reviewed on RxList: 4/27/2009
This monograph has been modified to include the generic and brand name in many instances.
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