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FLOVENT® HFA Inhalation Aerosol 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 HFA 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 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 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 1.
Table 1: Recommended Dos ages of FLOVENT HFA
NOTE: In all patients, it is desirable to titrate to the lowest effective dos age once asthma stability is achieved.
|Previous Therapy||Recommended Starting Dosage||Highest Recommended Dosage|
|Adult and adolescent patients (aged 12 years and older)|
|Bronchodilators alone||88 mcg twice daily||440 mcg twice daily|
|Inhaled corticosteroids||88-220 mcg twice daily3||440 mcg twice daily|
|Oral corticosteroidsb||440 mcg twice daily||880 mcg twice daily|
|Pediatric patients (aged 4-11 years)c||88 mcg twice daily||88 mcg twice daily|
|aStarting 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 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 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 AND PRECAUTIONS]. Once prednisone reduction is complete, the dosage of FLOVENT HFA should be reduced to the lowest effective dosage.
cRecommended pediatric dosage is 88 mcg twice daily regardless of prior therapy. A valved holding chamber and mask may be used to deliver FLOVENT HFA to young patients.
Prime FLOVENT HFA before using for the first time by releasing 4 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 spray into the air away from the face.
Dosage Forms And Strengths
Inhalation Aerosol. Dark orange plastic inhaler with a peach strapcap containing a pressurized metereddose aerosol canister containing 120 metered inhalations and fitted with a counter. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the mouthpiece.
Storage And Handling
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 counter and supplied with a dark orange actuator with a peach strapcap. Each inhaler is packaged with a Patient Information 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 canister into fire or incinerator.
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 the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. Shake well before EACH SPRAY.
GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: Dec 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/26/2016
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