Consumer medicine information

1. Why am I using QVAR?

QVAR contains the active ingredient beclometasone dipropionate. Beclometasone dipropionate is a corticosteroid that acts directly on your air passages to reduce inflammation. This helps to improve your condition and to prevent asthma attacks.
For more information, see Section 1. Why am I using QVAR? in the full CMI.

2. What should I know before I use QVAR?

Do not use if you have ever had an allergic reaction to QVAR or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use QVAR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with QVAR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use QVAR?

• Your doctor will prescribe the strength and dose of QVAR for you to take that best suit your condition.

• Follow all directions given by your doctor or other healthcare professionals and never change the dose yourself.

5. What should I know while using QVAR?

6. Are there any side effects?

Less serious side effects include sore, creamy-yellow raised patches in the mouth (thrush), a hoarse voice, rashes, itching or irritation and redness and swelling of the face, lips, mouth, throat and eyes. Serious side effects include narrowing of the airways or chest tightness, changes to your eyesight or vision including blurred vision or other visual disturbances, stunted growth or a reduced growth rate in children and adolescents.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Beclomethasone dipropionate.

2 Qualitative and Quantitative Composition

Beclometasone dipropionate (BDP) is a white to creamy white, odourless powder; it is slightly soluble in water, very soluble in chloroform and freely soluble in acetone and alcohol. Qvar also contains ethanol and norflurane (HFA-134a), a propellant which does not contain chlorofluorocarbons (CFCs).
Excipients with known effects. Ethanol (alcohol) 11.85% v/v.
Qvar 50 Inhaler and Autohaler deliver 50 microgram of BDP per inhalation. Qvar 100 Inhaler and Autohaler deliver 100 microgram of BDP per inhalation.
Qvar Autohaler is a breath actuated inhaler which automatically releases a metered dose of medication during inhalation through the mouthpiece and overcomes the need for patients to coordinate actuation with inspiration. Qvar Inhaler is a conventional press and breathe metered dose inhaler (PandB MDI). There are no differences in formulation between the Autohaler and the Inhaler products.
Qvar contains BDP in solution, resulting in an extra fine aerosol. The aerosol droplets of Qvar are on average much smaller (Mass Median Aerodynamic Diameter (MMAD), MMAD range 0.8 to 1.2 microns) than the particle sizes delivered by CFC suspension formulations (MMAD range 3.5 to 4 microns) or dry powder formulations (MMAD approximately 10 microns) of BDP. The smaller particle size for Qvar results in greater deposition in the airways and less deposition in the oropharynx than beclometasone products formulated in CFCs.
Radiolabelled deposition studies demonstrated that for Qvar the majority of BDP (> 55% dose ex-actuator) is deposited in the lungs and a small amount (< 35% dose ex-actuator) is deposited in the oropharynx. In contrast, approximately 4-7% dose from the actuator of BDP formulated in chlorofluorocarbons (CFC-BDP) is deposited in the lungs and over 90% is deposited in the oropharynx. The imaging data suggest that for Qvar, BDP is deposited widely throughout the central, intermediate and peripheral airways whereas deposition is limited to the central airways for CFC-BDP. The smaller particle size of Qvar explains the different deposition patterns compared with CFC-BDP. These delivery characteristics result in equivalent therapeutic effects being achieved at lower total daily doses of Qvar compared to CFC-BDP, and account for the recommended dosage adjustment when switching patients from CFC-BDP to Qvar (see Section 4.2 Dose and Method of Administration).

3 Pharmaceutical Form

Beclometasone dipropionate 50 mcg per actuation pressurised inhalation aerosol can (Qvar 50 Autohaler): colourless solution.
Beclometasone dipropionate 50 mcg per actuation pressurised inhalation aerosol can (Qvar 50 Inhaler): colourless solution.
Beclometasone dipropionate 100 mcg per actuation pressurised inhalation aerosol can (Qvar 100 Autohaler): colourless solution.
Beclometasone dipropionate 100 mcg per actuation pressurised inhalation aerosol can (Qvar 100 Inhaler): colourless solution.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
The harmful effect that follows inhalation of large amounts of Qvar over a short time period is suppression of HPA function. Specific emergency action need not be taken. Treatment with Qvar should be continued at the recommended dose to control the asthma; HPA function recovers in a day or two.
If excessive doses of BDP were taken over a prolonged period a degree of atrophy of the adrenal cortex could occur in addition to HPA suppression. In this event the patient should be treated as steroid dependent and transferred to a suitable maintenance dose of a systemic steroid such as prednisolone. Regular tests of adrenal function are advised. Once the condition is stabilised, the patient should be returned to Qvar by the recommended method (see Section 4.2 Dose and Method of Administration).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. Potential carcinogenicity and mutagenicity have not been adequately investigated in animal studies of BDP. Other glucocorticoids (budesonide, prednisolone and triamcinolone acetate) have been shown to increase the incidence of hepatocellular tumours in rats by a nongenotoxic mechanism.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Its molecular formula is C₂₈H₃₇ClO₇ (molecular weight: 521.1).
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBECDIP.gif CAS number. 5534-09-8.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

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