2.1 Administration Information
Administer QVAR by the orally inhaled route only. Patients should prime QVAR by actuating into the air twice before using for the first time or if QVAR has not been used for over 10 days. Avoid spraying in the eyes or face when priming QVAR. QVAR is a solution aerosol, which does not require shaking. Consistent dose delivery is achieved, whether using the 40 or 80 mcg strengths, due to proportionality of the 2 products (i.e., 2 actuations of 40 mcg strength should provide a dose comparable to 1 actuation of the 80 mcg strength). Rinsing the mouth after inhalation is advised.
QVAR has a dose counter attached to the actuator. When the patient receives the inhaler, a black dot will appear in the viewing window until it has been primed 2 times, at which point the total number ofactuations will be displayed. The dose counter will count down each time a spray is released. The dose-counter window displays the number of sprays left in the inhaler in units of two (e.g., 120, 118, 116, etc). When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will change to solid red.
Discard QVAR inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comesfirst.
2.2 Maintenance Treatment of Asthma
QVAR should be administered by the oral inhaled route in patients 5 years of age and older. Use of QVAR with a spacer device in children less than 5 years of age is not recommended. [seeUse in Specific Populations (8.4)] The onset and degree of symptom relief will vary in individual patients. Improvement in asthma symptoms can occur within 24 hours of the beginning of treatment and should be expected within the first or second week, but maximum benefit should not be expected until 3 to 4 weeks of therapy. For patients who do not respond adequately to the starting dose after 3 to 4 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of QVAR when administered in excess of recommended doses has not been established.
Table 1 Recommended Dosing for Patients Aged 12 Years and Older
Patient’s Previous Therapy
Recommended Starting Dose
Highest Dose Recommended
Bronchodilators Alone
40 to 80 mcg twice daily
320 mcg twice daily
Inhaled Corticosteroids
40 to 160 mcg twice daily
320 mcg twice daily
Table 2 Recommended Dosing for Children 5 to 11 Years
Patient’s Previous Therapy
Recommended Starting Dose
Highest Dose Recommended
Bronchodilators Alone
40 mcg twice daily
80 mcg twice daily
Inhaled Corticosteroids
40 mcg twice daily
80 mcg twice daily
As with any inhaled corticosteroid, physicians are advised to titrate the dose of QVAR downward over time to the lowest level that maintains proper asthma control. This is particularly important in children since a controlled study has shown that QVAR has the potential to affect growth in children. Patients should be instructed on the proper use of their inhaler.
Patients Not Receiving Systemic Corticosteroids
Patients who require maintenance therapy of their asthma may benefit from treatment with QVAR at the doses recommended above. In patients who respond to QVAR, improvement in pulmonary function is usually apparent within 1 to 4 weeks after the start of therapy. Once the desired effect is achieved, consideration should be given to tapering to the lowest effective dose.
Patients Maintained on Systemic Corticosteroids
Prednisone or other oral corticosteroid should be weaned slowly beginning after at least 1 week of QVAR therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [See Warnings and Precautions (5.3)].