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FLOVENT® DISKUS® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years 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.
Important Limitation of Use
FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm.
DOSAGE AND ADMINISTRATION
FLOVENT DISKUS should be administered by the orally inhaled route only in patients aged 4 years and older. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
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 when administered in excess of recommended dosages have not been established.
The recommended starting dosage and the highest recommended dosage of FLOVENT DISKUS, based on prior asthma therapy, are listed in Table 1.
Table 1. Recommended Dosages of FLOVENT DISKUS
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|
|Adult and adolescent patients (aged 12 years and older) Bronchodilators alone Inhaled corticosteroids Oral corticosteroidsb||100 mcg twice daily 100-250 mcg twice dailya 500-1,000 mcg twice dailyc||500 mcg twice daily 500 mcg twice daily 1,000 mcg twice daily|
|Pediatric patients (aged 4-11 years)d||50 mcg twice dailya||100 mcg twice daily|
|a Starting dosages above 100 mcg twice daily
for adult and adolescent patients and 50 mcg twice daily for pediatric patients
aged 4 to 11 years 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 the specific agent.
bFor 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 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 AND PRECAUTIONS]. Once prednisone reduction is complete, the dosage of FLOVENT DISKUS should be reduced to the lowest effective dosage.
c The choice of starting dosage should be made on the basis of individual patient assessment. A controlled clinical trial of 111 oral corticosteroid-dependent subjects with asthma showed few significant differences between the 2 doses of FLOVENT DISKUS 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.
dBecause individual responses may vary, pediatric patients previously maintained on other inhaled corticosteroids may require dosage adjustments upon transfer to FLOVENT DISKUS.
Dosage Forms And Strengths
Inhalation Powder. Inhaler containing a foil blister strip of powder formulation for oral inhalation. The strip contains fluticasone propionate 50, 100, or 250 mcg per blister.
Storage And Handling
FLOVENT DISKUS 50 mcg is supplied as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moistureprotective foil pouch (NDC 0173-0600-02).
FLOVENT DISKUS 100 mcg is supplied as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0602-02). FLOVENT DISKUS 100 mcg is alsosupplied in an institutional pack containing 28 blisters (NDC 0173-0602-00).
FLOVENT DISKUS 250 mcg is supplied as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0601-02). FLOVENT DISKUS 250 mcg is also supplied in an institutional pack containing 28 blisters (NDC 0173-0601-00).
Store at room temperature between 68°F and 77°F) (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.
FLOVENT DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard FLOVENT DISKUS 6 weeks (50-mcg strength) or 2 months (100- and 250-mcg strengths) after opening the foil pouch or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: Apr 2014.
Last reviewed on RxList: 4/29/2014
This monograph has been modified to include the generic and brand name in many instances.
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