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Qvar

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Qvar

Qvar

INDICATIONS

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 administration, where adding QVAR may reduce or eliminate the need for the systemic corticosteroids.

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

DOSAGE AND ADMINISTRATION

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).

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 (see PRECAUTIONS, Pediatric Use). 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 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 2: Recommended Dosing for Adults and Adolescents

Patient's Previous Therapy Recommended Starting Dose Highest Recommended Dose
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 3: Recommended Dosing for Children 5 to 11 Years

Patient's Previous Therapy Recommended Starting Dose Highest Recommended Dose
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

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.

Directions For Use

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

HOW SUPPLIED

QVAR is supplied in 2 strengths:

QVAR 40 mcg is supplied either 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 or in an 8.7 g canister containing 120 actuations with a beige plastic actuator and gray dust cap, and Patient's Instructions; box of one; 120 Actuations – NDC 59310-202-40.

QVAR 80 mcg is supplied either in a 4.2 g canister, for Institutional Use, containing 50 actuations with a dark mauve plastic actuator and gray dust cap, and Patient's Instructions; box of one; 50 actuations – NDC 59310-204-50, 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, or in an 8.7 g canister containing 120 actuations with a dark mauve plastic actuator and gray dust cap, and Patient's Instructions; box of one; 120 Actuations – NDC 59310-204-80.

The correct amount of medication in each inhalation cannot be assured after 50 actuations from the 4.2 g canister, 100 actuations from the 7.3 g canister or 120 actuations from the 8.7 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.

Store at 25°C (77°F).

Excursions between 15° and 30°C (59° and 86°F) 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.

Contents Under Pressure

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

Keep out of reach of children.

Mktd by: Teva Respiratory, LLC– Horsham, PA 19044. Developed and Manufactured by: 3M Drug Delivery Systems Northridge, CA 91324 OR 3M Health Care, Ltd. Loughborough, UK. July 2012

Last reviewed on RxList: 8/9/2012
This monograph has been modified to include the generic and brand name in many instances.

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