INDICATIONS AND USAGE

FLOVENT Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy. 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 Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

FLOVENT Inhalation Aerosol should be administered by the orally inhaled route in patients 12 years of age and older. Individual patients will experience a variable time to onset and degree of symptom relief. Generally, FLOVENT Inhalation Aerosol has a relatively rapid onset of action for an inhaled glucocorticoid. Improvement in asthma control following inhaled administration of fluticasone propionate can occur within 24 hours of beginning treatment, although maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. A

fter asthma stability has been achieved (see Table 2), 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 Inhalation Aerosol when administered in excess of recommended dosages have not been established.

The recommended starting dosage and the highest recommended dosage of FLOVENT Inhalation Aerosol, based on prior antiasthma therapy, are listed in Table 2.

Table 2. Recommended Dosages of FLOVENT Inhalation Aerosol

Previous Therapy Recommended Starting Dosage Highest Recommended Dosage

Bronchodilators alone 88 mcg twice daily 440 mcg twice daily

Inhaled corticosteroids 88-220 mcg twice daily * 440 mcg twice daily

Oral corticosteroids * 880 mcg twice daily 880 mcg twice daily *

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 that specific agent.