QVAR MDI Pressurised inhalation, solution Ref.[9889] Active ingredients: Beclometasone

Posology

NOTE: The recommended total daily dose of Qvar is lower than that for current beclometasone dipropionate containing products and should be adjusted to the needs of the individual patient.

It is important to gain control of asthma symptoms and optimise pulmonary function as soon as possible. When patients' symptoms remain under satisfactory control, the dose should be titrated to the lowest dose at which effective control of asthma is maintained.

To be effective, inhaled Qvar must be used on a regular basis even when patients are asymptomatic.

Adults and adolescents over 12 years starting and maintenance dose

Therapy in new patients should be initiated at the following dosages:

Mild asthma: 100 to 200 micrograms per day in two divided doses.

Moderate asthma: 200 to 400 micrograms per day in two divided doses.

Severe asthma: 400 to 800 micrograms per day in two divided doses.

Patients on budesonide inhalers may be transferred to Qvar as described below.

The general approach to switching patients to Qvar involves two steps as detailed below. Specific guidance on switching well-controlled and poorly-controlled (symptomatic) patients is given below the table.

Step 1: Consider the dose of budesonide-containing inhalers appropriate to the patient’s current condition.

Step 2: Convert the budesonide inhaler dose to the Qvar dose according to the table below.

Total Daily Dose (mcg/day):

Patients with well-controlled asthma using budesonide inhaler products should be switched to Qvar at a dose in accordance with the table above.

For example:

Patients on 2 puffs twice daily of budesonide 100 micrograms would change to 2 puffs twice daily of Qvar 50 micrograms.

Patients with poorly-controlled asthma may be switched from budesonide inhaler products to Qvar at the same microgram for microgram dose up to 800 micrograms daily.

Alternatively the patient’s current budesonide inhaler dose can be doubled and this dose can be converted to the Qvar dose according to the table above.

Patients on fluticasone inhalers may be transferred to the same total daily dose of Qvar up to 800 micrograms daily.

Once transferred to Qvar the dose should be adjusted to meet the needs of the individual patient.

The maximum recommended dose is 800 micrograms per day in divided doses.

The same total daily dose in micrograms from either Qvar 50 or Qvar 100 (a higher strength) Aerosol provides the same clinical effect.

Children aged 5 years and over starting and maintenance dose

Therapy in new patients should be initiated at the following dosages:

Mild asthma: 100 micrograms per day in two divided doses.

Moderate asthma: 100 to 200 micrograms per day in two divided doses.

Severe asthma: 200 micrograms per day in two divided doses.

The minimum recommended dose is 50 micrograms twice daily and the maximum recommended dose is 100 micrograms twice daily, representing a total daily dose of 100 and 200 micrograms, respectively.

Children with well-controlled asthma on doses of up to 400 micrograms per day of beclometasone dipropionate administered from other currently available beclometasone dipropionate inhalers or equivalent may be titrated to a dose of 100-200 micrograms (in two divided doses) per day of Qvar.

During periods of deterioration in asthma control, the dose of beclometasone dipropionate may be increased to 200 micrograms per day in two divided doses. The dose should then be reduced to the minimum needed to maintain effective control of asthma.

Patients on fluticasone or budesonide inhalers may be switched to Qvar using the approach described earlier for adults and adolescents.

Once transferred to Qvar the dose should be adjusted to meet the needs of the individual patient.

Special patient groups

No special dosage recommendations are made for elderly or patients with hepatic or renal impairment.

Method of administration

Qvar is for inhalation use.

Patients and carers should be instructed in the proper use of the inhaler, including rinsing out the mouth with water after use.

Patients should be advised that Qvar may have a different taste and feel compared to other inhalers.

Qvar Aerosol is recommended for those patients who have demonstrated consistent good technique with co-ordinating actuation and inhalation.

The parent/guardian/carer as well as the patient should read the instruction leaflet before use.

Before first use of the inhaler, or if the inhaler has not been used for two weeks or more, prime the inhaler by releasing two puffs into the air.

Where a spacer is considered necessary for specific patient needs, Qvar Aerosol can be used with AeroChamber Plus holding chamber, as the extrafine particle fraction is maintained. The AeroChamber Plus spacing device/holding chamber is used in patients who have difficulty synchronising aerosol actuation with inspiration of breath to ensure proper administration of the drug.

The AeroChamber Plus should always be used with Qvar when administered to children under 12 years old.

Qvar delivers a consistent dose, at temperatures as low as -10°C, without the need for the patient to wait between individual actuations.

Instructions for use

There is no need to shake the inhaler before use, as it is a solution.

Instruct the patient, parent or guardian/carer to remove the mouthpiece cover and check that the inhaler is clean and free from foreign objects. The patient should be advised to breathe out as far as is comfortable before placing the inhaler into their mouth. They should then close their lips tightly around the mouthpiece and breathe in steadily and deeply through the mouth. After starting to breathe in, the patient should be instructed to press down on the canister so that a puff can be released, whilst still breathing steadily and deeply. It is important to carry on breathing after the puff is released. Whilst the patient is still breathing in, the inhaler should be removed from their mouth and they should hold their breath for 10 seconds and then breathe out slowly. The patient should not breathe out into the inhaler. If another dose is required, the patient should repeat the procedure as described above. After use, replace the mouthpiece cover.

Children should be told not to rush the procedure. It is important that the patient breathes in as slowly as possible prior to actuation. The patient should be told that if a mist appears on inhalation, they should not worry but the procedure should be repeated.

Children with weak hands might find it helpful to hold the inhaler in both hands placing both forefingers on the top of the inhaler and both thumbs on the bottom of the inhaler.

In order to co-ordinate actuation with inspiration of breath, children should always use a spacer. The AeroChamber Plus spacer device fits Qvar 50/100 Aerosol. The child, parent or guardian/carer is advised to refer to and follow the instructions provided with the AeroChamber Plus device.

After using the inhaler, the patient should thoroughly rinse their mouth, gargle with water or brush their teeth.

It is important for the patient to clean their inhaler at least weekly to prevent any blockage and to carefully follow the cleaning instructions as provided in the Patient Information Leaflet. It is important not to put the inhaler in water.

Acute overdosage is unlikely to cause problems. The only harmful effect that follows inhalation of large amounts of the drug over a short time period is suppression of HPA axis function. Specific emergency action need not be taken. Treatment with Qvar should be continued at the recommended dose to control the asthma; HPA axis function recovers in a day or two.

If excessive doses of beclometasone dipropionate were taken over a prolonged period a degree of atrophy of the adrenal cortex could occur in addition to HPA axis 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. Once the condition is stabilised, the patient should be returned to Qvar by the method described above in section 4.4.

Shelf life: 3 years.

Do not store above 25°C. Protect from frost and direct sunlight.

The canister contains a pressurised liquid. Do not expose to temperatures higher that 50°C. Do not pierce the canister.

Pressurised aluminium canister closed with a metering valve containing either 100 or 200 actuations.

Not all pack sizes may be marketed.

Not applicable.