View Floven HFA Drug Facts Sheet.
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.
Recommended Dosages of FLOVENT HFA Inhalation Aerosol
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 yearsand older) |
|
|
Bronchodilators alone |
88 mcg twice daily |
440 mcg twice daily |
Inhaled corticosteroids |
88-220 mcg twice dailya |
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 |
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 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 metered-dose 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.
Cautions
Keep out of reach of children and pets. Store at room temperature. Shake product well before use.
Contraindications
- Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures.
- Hypersensitivity to any ingredient.
Warnings & Precautions
- Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
- Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
- Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to FLOVENT HFA.
- Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue FLOVENT HFA slowly.
- Assess for decrease in bone mineral density initially and periodically thereafter.
- Monitor growth of pediatric patients.
- Close monitoring for glaucoma and cataracts is warranted.
Adverse Reactions
Most common adverse reactions (incidence greater than 3%) are upper respiratory tract infection or inflammation, throat irritation, sinusitis, dysphonia, candidiasis, cough, bronchitis, and headache.
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.