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QVAR EASI-BREATHE is a brand name for Beclomethasone (also known as Beclometasone). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prophylactic management of mild, moderate or severe asthma.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Qvar Easi-Breathe 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.
NOTE:
The recommended total daily dose of Qvar Easi-Breathe is lower than that for current beclometasone dipropionate 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 Easi-Breathe must be used on a regular basis even when patients are asymptomatic. THERAPY IN NEW PATIENTS SHOULD BE INITIATED AT THE FOLLOWING 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) Budesonide inhaler 200- 250 300 400- 500 600- 750 800- 1000 1100 1200- 1500 1600- 2000 QVAR 100 150 200 300 400 500 600 800 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.
A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely. As with other inhaled therapy, paradoxical bronchospasm may occur after dosing. Immediate treatment with a short-acting bronchodilator should be initiated, Qvar should be discontinued immediately and an alternate prophylactic treatment introduced.
Systemic effects of inhaled corticosteroids may occur, particularly with high doses prescribed for prolonged periods. These include adrenal suppression, growth retardation in children, decrease in bone mineral density and the occurrence of cataract and glaucoma.
Commonly, when taking Qvar, hoarseness and candidiasis of the throat and mouth may occur. To reduce the risk of hoarseness and candida infection, patients are advised to rinse their mouth after using their inhaler. Based on the MedDra system organ class and frequencies, adverse events are listed in the table below according to the following frequency estimate: very common (≥ 1/10); common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
4 Special warnings and precautions for use). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Patients should be properly instructed on the use of the inhaler to ensure that the drug reaches the target areas within the lungs. To be effective, Qvar Easi-Breathe must be used by patients on a regular basis, even when patients do not have asthma symptoms.
When symptoms are controlled, maintenance Qvar Easi-Breathe therapy should be reduced in a stepwise manner to the minimum effective dose. Inhaled steroid treatment should not be stopped abruptly. Patients with asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests.
Qvar Easi-Breathe is not indicated for the immediate relief of asthma attacks. Patients therefore need to have relief medication (inhaled short-acting bronchodilator) available for such circumstances. Severe asthma requires regular medical assessment, including lung-function testing, as there is a risk of severe attacks and even death.
Patients should be instructed to seek medical attention if short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required as this may indicate deterioration of asthma control. If this occurs, patients should be assessed and the need for increased anti-inflammatory therapy considered (eg.
higher doses of inhaled corticosteroid or a course of oral corticosteroid). e. by increasing the dose of inhaled beclometasone dipropionate, giving a systemic steroid if necessary, and/or an appropriate antibiotic if there is an infection, together with β- agonist therapy.
Treatment with Qvar should not be stopped abruptly. However, systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids.
Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma, blurred vision, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 Easi-Breathe 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 Easi-Breathe 50 (a lower strength) or Qvar Easi-Breathe 100 Inhaler provides the same clinical effect.
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 Easi-Breathe may have a different taste and feel than a CFC inhaler. Paediatric population There are no data to date on Qvar Easi-Breathe in children under 12 years of age, hence no definitive dosage recommendation can be made.
Special patient groups No special dosage recommendations are made for elderly or patients with hepatic or renal impairment. Method of administration The aerosol spray is inhaled through the mouth into the lungs. The inhaler should be primed by firing two shots into the air before first use or if the inhaler has not been used for a period of two weeks or longer.
After removal of the cap the inhaler mouthpiece should be placed in the mouth with the lips closed around it. The patient should breathe in slowly and deeply through the mouthpiece. They should be advised not to stop breathing when the inhaler delivers the dose into their mouth but carry on until they have taken a deep breath to ensure optimal delivery of the product.
For normal hygiene, the mouthpiece of the inhaler should be cleaned weekly with a clean dry tissue or cloth. The inhaler should not be washed or immersed in water at any time. Full instructions for use are given in the Patient Information Leaflet, which should be read carefully by the patient before use.
Qvar Easi-Breathe 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.
It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained. It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored.
If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.
Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than the recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Patients who have received systemic steroids for long periods of time or at high doses, or both, need special care and subsequent management when being transferred to inhaled steroid therapy. Patients should have stable asthma before being given inhaled steroids in addition to the usual maintenance dose of systemic steroid.
Withdrawal of systemic steroids should be gradual, starting about seven days after the introduction of Qvar Easi-Breathe therapy. For daily oral doses of prednisolone of 10mg or less, dose reduction in 1mg steps, at intervals of not less than one week is recommended.
For patients on daily maintenance doses of oral prednisolone greater than 10mg, larger weekly reductions in the dose might be acceptable. The dose reduction scheme should be chosen to correlate with the magnitude of the maintenance systemic steroid dose.
As recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy is slow, adrenocortical function should be monitored regularly. Patients should be advised that they may feel unwell in a non-specific way during systemic steroid withdrawal despite maintenance of, or even improved respiratory function.
Patients should be advised to persevere with their inhaled product and to continue withdrawal of systemic steroids, even if feeling unwell, unless there is evidence of HPA axis suppression. Patients weaned off oral steroids whose adrenocortical function is impaired should carry a steroid warning card indicating that they may need supplementary systemic steroids during periods of stress, eg.
worsening asthma attacks, chest infections, major intercurrent illness, surgery, trauma, etc. Discontinuation of systemic steroids may also cause exacerbation of allergic diseases such as atopic eczema and rhinitis. These should be treated as required with topical therapy, including corticosteroids and/or antihistamines.
Like other corticosteroids, caution is necessary in patients with active or latent pulmonary tuberculosis. Patients should be advised to seek medical attention for review of maintenance Qvar Easi-Breathe therapy if peak flow falls, symptoms worsen or if the short-acting bronchodilator becomes less effective and increased inhalations are required.
This may indicate worsening asthma. Most patients can be successfully transferred to inhaled steroids with maintenance of good respiratory function, but special care is necessary for the first few months after the transfer, until the hypothalamic-pituitary-adrenal (HPA) system has sufficiently recovered to enable the patient to cope with stressful emergencies such as trauma, surgery or serious infections.
Patients should, therefore, carry a steroid warning card to indicate the possible need to re-instate systemic steroid therapy rapidly during periods of stress or where airways obstruction or mucus significantly […]