RESPOCORT

NOTE:

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

ADULTS ANND ADOLESCENTS OVER 12 YEARS 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 Respocort 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 Patients on budesonide inhalers may be transferred to Respocort as described below: The general approach to switching patients to Respocort 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 dose to the Respocort dose according to the table below. Daily Dose of Beclometasone Dipropionate (micrograms) Budesonide Inhaler 200- 250 300 400- 500 600- 750 800- 1000 1100 1200- 1500 1600- 2000 Respocort 100 150 200 300 400 500 600 800 Patients with well-controlled asthma using budesonide inhaler products should be switched to Respocort at a dose in accordance with the table above.

For example:

Patients on 2 puffs twice daily of budesonide 200 micrograms would change to 2 puffs twice daily of Respocort 100 micrograms. Patients with poorly-controlled asthma may be switched from budesonide inhaler products to Respocort at the same microgram for microgram dose up to 800 micrograms daily.

Alternatively the patient’s current budesonide inhalee dose can be doubled and this dose can be converted to the Respocort dose according to the table above. Patients on fluticasone inhalers may be transferred to the same total daily dose of Respocort up to 800 micrograms daily.

Once transferred to Respocort 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.

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 Respocort.

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 Respocort using the approach described earlier for adults and adolescents. Once transferred to Respocort 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 Respocort 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 Respocort may have a different taste and feel compared to other inhalers. Respocort 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 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.

Respocort 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 Autohaler device should be held upright. The lever should be pushed to the upward position.

As this is an automatic device, the dose will automatically be released when the patient begins breathing with the inhaler. 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 not stop breathing when there is a slight click and when they feel the actuation in their mouth as 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. After receiving the puff, the lever must be lowered […]

A serious hypersensitivity reactions including oedema of the eyes, face, lips and throat (angioedema) has been reported rarely. As with other inhalation therapy, paradoxical bronchospasm may occur after dosing. Immediate treatment with a short-acting bronchodilator should be initiated.

Respocort should be discontinued immediately and alternative prophylactic therapy introduced. Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. 4). Commonly, when taking Respocort hoarseness and candidiasis of the mouth and throat 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, Respocort must be used by patients on a regular basis, even when patients do not have asthma symptoms.

When symptoms are controlled, maintenance Respocort 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.

Respocort 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. Respocort is not indicated in the management of status asthmaticus.

Severe asthma exacerbations should be managed in the usual way. Subsequently, it may be necessary to increase the dose of Respocort up to the maximum daily dose. Systemic steroid treatment may be needed and/or an antibiotic, if there is an infection, together with β-agonist therapy, as needed.

Severe asthma requires regular medical assessment, including lung-function testing, as there is a risk of severe attacks and even death. Patients should be advised to seek medical attention as soon as possible for review of Respocort therapy if their peak flow falls, symptoms worsen or if their short-acting bronchodilator becomes less effective or increased inhalations than usual are required.

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).

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 Respocort 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.

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 compromises the inhaled route of administration.

In addition, it may be advisable to provide such patients with a supply of corticosteroid tablets to use in these circumstances. The dose of inhaled steroids should be increased at this time and then gradually reduced to the maintenance level after the systemic steroid has been discontinued.

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. 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. Beclometasone dipropionate, like other inhaled steroids, is absorbed into the systemic circulation from the lungs. Beclometasone dipropionate and its metabolites may exert detectable suppression of adrenal function.

Within the dose range 100-800 micrograms daily, clinical studies with Respocort have demonstrated mean values for adrenal function and responsiveness within the normal range. 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 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).

Therefore, it is important that the dose of inhaled corticosteroid is reviewed regularly and 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.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other […]

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