Posology : מינונים

4.2      Posology and method of administration

Qvar is for inhalation use only.

Patients should be instructed in the proper use of their inhaler, including rinsing out their mouth with water after use. Patients should be advised that Qvar may have a different taste and feel than a CFC inhaler.

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

ADULT STARTING AND MAINTENANCE DOSE:
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.

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.
TRANSFERRING PATIENTS TO QVAR FROM A CFC-CONTAINING INHALER

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 CFC containing beclometasone dipropionate product appropriate to the patient’s current condition.

Step 2: Convert the CFC containing beclometasone dipropionate dose to the Qvar dose according to the table below.


Total Daily Dose (mcg/day)
CFC       200-250 300      400-500 600-750 800-                    1100      1200-   1600- BDP*                                       1000                              1500    2000 QVAR 100           150     200      300    400                     500       600     800 *CFC-BDP = CFC beclometasone dipropionate

1. Dosing in well-controlled patients with asthma

Patients with well-controlled asthma using beclometasone dipropionate CFC containing product should be switched to Qvar at a dose in accordance with the table above.

For example:

Patients on 2 puffs twice daily of CFC beclometasone dipropionate 100 micrograms would change to 2 puffs twice daily of Qvar 50 micrograms.

Patients on 2 puffs twice daily of CFC beclometasone dipropionate 200 micrograms would change to 2 puffs twice daily of Qvar 100 micrograms.

2. Dosing in poorly-controlled (symptomatic) patients with asthma

Patients with poorly-controlled asthma may be switched from CFC containing beclometasone dipropionate products to Qvar at the same microgram for microgram dose up to 800 micrograms daily. Comparative clinical studies have demonstrated that asthma patients achieve equivalent pulmonary function and control of symptoms with Qvar at lower total daily doses than with CFC containing beclometasone dipropionate products.

Alternatively the patient’s current CFC containing beclometasone dipropionate dose can be doubled and this dose can be converted to the Qvar dose according to the table above.


Patients on budesonide inhalers may be transferred to Qvar as described for CFC containing beclometasone dipropionate products.

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

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 aerosol provides the same clinical effect.

CHILDREN 5 YEARS OF AGE AND OLDER

With mild persistent or moderate asthma: 50 micrograms two times per day.
In severe cases: 100 micrograms two times per day.
The maximum recommended daily dose in children is 100 micrograms two times per day.
As the use of a spacing device might be needed, certain spacing devices can be used with this product.

SPECIAL PATIENT GROUPS

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

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

Qvar Autohaler is a breath-actuated inhaler which automatically releases the metered dose of medication during a patient’s inhalation through the mouthpiece and overcomes the need for patients to have good manual co- ordination.

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 with AeroChamber Plus™ holding chamber, as the extrafine particle fraction is maintained.

Qvar delivers a consistent dose
- whether or not the canister is shaken by the patient
- without the need for the patient to wait between individual actuations - regardless of storage orientation or periods without use of up to 14 days - at temperatures as low as -10°C.