QVAR is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. QVAR is also indicated for asthma patients who require systemic corticosteroid administra-tion, where adding QVAR may reduce or eliminate the need for the systemic corticosteroids.

Beclomethasone dipropionate is NOT indicated for the relief of acute bronchospasm.

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 ten 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 two products (i. e. , two actuations of 40 mcg strength should provide a dose comparable to one actuation of the 80 mcg strength).

QVAR should be administered by the oral inhaled route in patients 5 years of age and older. The onset and degree of symptom relief will vary in individual patients. Improvement in asthma symptoms should be expected within the first or second week of starting treatment, but maximum benefit should not be expected until 3-4 weeks of therapy. For patients who do not respond adequately to the starting dose after 3-4 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.

The recommended dosage of QVAR relative to CFC-based beclomethasone dipropionate (CFC-BDP) inhalation aerosols is lower due to differences in delivery characteristics between the products. Recognizing that a definitive comparative therapeutic ratio between QVAR and CFC-BDP has not been demonstrated, any patient who is switched from CFC-BDP to QVAR should be dosed appropriately, taking into account the dosing recommendations above, and should be monitored to ensure that the dose of QVAR selected is safe and efficacious. 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 should be advised that QVAR may have a different taste and inhalation sensation than that of an inhaler containing CFC propellant.

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, considera-tion should be given to tapering to the lowest effective dose.

QVAR may be effective in the management of asthmatics maintained on systemic corticosteroids and may permit replacement or significant reduction in the dosage of systemic corticosteroids.

The patient’s asthma should be reasonably stable before treatment with QVAR is started. Initially, QVAR should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroids. After approximately one week, gradual withdrawal of the systemic corticosteroids is started by reducing the daily or alternate daily dose. Reductions may be made after an interval of one or two weeks, depending on the response of the patient. A slow rate of withdrawal is strongly recommended. Generally these decrements should not exceed 2. 5 mg of prednisone or its equivalent. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e. g. joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with the inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly.

During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.

Illustrated Patient’s Instructions for proper use accompany each package of QVAR.

QVAR is supplied in two strengths:

QVAR 40 mcg is supplied in a 7. 3 g canister containing 100 actuations with a beige plastic actuator and gray dust cap, and Patient’s Instructions; box of one; 100 Actuations - NDC 59310-175-40

QVAR 80 mcg is supplied in a 7. 3 g canister containing 100 actuations with a dark mauve plastic actuator and gray dust cap, and Patient’s Instructions; box of one; 100 Actuations - NDC 59310-177-80 The correct amount of medication in each inhalation cannot be assured after 100 actuations from the 7. 3 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

Store QVAR Inhalation Aerosol when not being used, so that the product rests on the concave end of the canister with the plastic actuator on top.

Excursions between 15º and 30ºC (59º and 86ºF) are permitted (see USP). For optimal results, the canister should be at room temperature when used. QVAR Inhalation Aerosol canister should only be used with the QVAR Inhalation Aerosol actuator and the actuator should not be used with any other inhalation drug product.

Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49ºC (120ºF) may cause bursting. Never throw container into fire or incinerator.

Distributed by: IVAX Laboratories, Inc. Miami, Fl 33137, Developed and Manufactured by: 3M Pharmaceuticals OR 3M Health Care, Ltd. Northridge, CA 91324, Loughborough, UK, MAY 2002, QVAR^® is a registered trademark of 3M through its subsidiary, Riker Labs. , Inc. and is used under license. , 625702 Rev. 05/02,

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