Floventhfa Hfa
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FDA Labeling Changes
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Uses
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.
FLOVENT HFA Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.
History
There is currently no drug history available for this drug.
Other Information
The active component of FLOVENT HFA 44 mcg Inhalation Aerosol, FLOVENT HFA 110 mcg Inhalation Aerosol, and FLOVENT HFA 220 mcg Inhalation Aerosol is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:
Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.
FLOVENT HFA 44 mcg Inhalation Aerosol, FLOVENT HFA 110 mcg Inhalation Aerosol, and FLOVENT HFA 220 mcg Inhalation Aerosol are pressurized metered-dose aerosol units fitted with a counter. FLOVENT HFA is intended for oral inhalation only. Each unit contains a microcrystalline suspension of fluticasone propionate (micronized) in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients.
After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate in 60 mg of suspension (for the 44-mcg product) or in 75 mg of suspension (for the 110- and 220-mcg products) from the valve. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system.
Each 10.6-g canister (44 mcg) and each 12-g canister (110 and 220 mcg) provides 120 inhalations.
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.
This product does not contain any chlorofluorocarbon (CFC) as the propellant.
Sources
Floventhfa Hfa Manufacturers
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Remedyrepack Inc.
![Floventhfa Hfa (Fluticasone Propionate) Aerosol, Metered [Remedyrepack Inc. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Floventhfa Hfa | Remedyrepack Inc.
FLOVENT HFA should be administered by the orally inhaled route only in patients aged 4 years 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 1.
Table 1. Recommended Dosages of FLOVENT HFA Inhalation AerosolNOTE: 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)
88 mcg twice daily
88-220 mcg twice dailya
440 mcg twice daily
440 mcg twice daily
440 mcg twice daily
880 mcg twice daily
Bronchodilators alone
Inhaled corticosteroids
Oral corticosteroidsb
Pediatric patients (aged 4-11 years)c
88 mcg twice daily
88 mcg twice daily
a 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 the specific agent.
b 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 and Precautions (5.4)]. Once prednisone reduction is complete, the dosage of FLOVENT HFA should be reduced to the lowest effective dosage.
c Recommended pediatric dosage is 88 mcg twice daily regardless of prior therapy. A valved holding chamber and face mask may be used to deliver FLOVENT HFA to young patients.
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.
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