April 28, 2017
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Qvar

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Qvar




Indications
Dosage
How Supplied

INDICATIONS

Treatment Of Asthma

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.

Important Limitations of Use
  • QVAR is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

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.

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. [see Use In Specific Populations] 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].

HOW SUPPLIED

Dosage Forms And Strengths

QVAR is a pressurized, metered-dose aerosol with a dose counter intended for oral inhalation containing beclomethasone dipropionate in the following 2 strengths:

QVAR 40 mcg is supplied in an aluminum canister with a beige plastic actuator with a dose counter and a gray dust cap. Each actuation delivers 50 mcg of beclomethasone dipropionate from the valve and 40 mcg from the actuator. QVAR 40 mcg is available as a 120-inhalation/8.7 g canister.

QVAR 80 mcg is supplied in an aluminum canister with a dark mauve plastic actuator with a dose counter and a gray dust cap. Each actuation delivers 100 mcg of beclomethasone dipropionate from the valve and 80 mcg from the actuator. QVAR 80 mcg is available as a 120-inhalation/8.7 g canister.

Storage And Handling

QVAR is supplied in 2 strengths:

QVAR 40 mcg is supplied in a box of one 8.7 g canister containing 120 actuations with a beige plastic actuator with a dose counter and gray dust cap, and Patient Information and Instructions for Use; box of one; 120 Actuations – NDC 59310-202-12.

QVAR 80 mcg is supplied in a box of one 8.7 g canister containing 120 actuations with a dark mauve plastic actuator with a dose counter and gray dust cap, and Patient Information and Instructions for Use; box of one; 120 Actuations – NDC 59310-204-12.

The correct amount of medication in each inhalation cannot be assured after 120 actuations from the 8.7 g canister even though the canister is not completely empty. Patients should be informed todiscard theQVAR inhaler when the dose counter displays 0 or after the expirationdate on the product, whichever comes first.

Storage And Handling

Store at 25° C (77° F).

Excursions between 15° and 30°C (59° and 86°F) are permitted (see USP Controlled Room Temperature). 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.

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

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.

Manufactured By: 3M Drug Delivery Systems AND/OR 3M Health Care, Ltd. Northridge, CA 91324 Loughborough, UK. Revised: Jul 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/10/2016

Indications
Dosage
How Supplied

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