Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Beclometasone dipropionate given by inhalation offers preventative treatment for asthma. It provides effective anti-inflammatory action in the lungs with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically. Becloforte Inhaler is indicated in the prophylactic management of severe asthma in adults.

Severe asthma: Patients with severe chronic asthma and those who are dependent on systemic corticosteroids for adequate control of symptoms. Many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly, or eliminate, their requirement for oral corticosteroids when they are transferred to high dose inhaled beclometasone dipropionate.

Adult Dosage

Becloforte Inhaler is for oral inhalation use only.

Some patients find difficulty in co-ordinating the firing of an inhaler with inspiration and therefore fail to maximise the potential benefit offered by treatment. Becloforte Inhaler may be used with a Volumatic™ spacer device by patients who find it difficult to synchronise aerosol actuation with inspiration of breath.

Patients should be given a starting dose of inhaled beclometasone dipropionate appropriate to the severity of their disease. Those demonstrating a need for high dose inhaled steroid therapy should start on 1,000 micrograms daily. The dose may then be adjusted until control is achieved and should be titrated to the lowest dose at which effective control of asthma is maintained.

Adults (including the elderly): 1,000 micrograms daily which may be increased to 2,000 micrograms daily. This may then be reduced when the patient's asthma has stabilised. The total daily dose may be administered as two, three, or four divided doses

For optimum results Becloforte Inhaler should be used regularly, even when patients are asymptomatic.

Child Dosage

Contra Indications

Hypersensitivity to any of the components.

Special care is necessary in patients with active or quiescent pulmonary tuberculosis.

Special Precautions

Patients' inhaler technique should be checked to make sure that aerosol actuation is synchronised with inspiration of breath for optimum delivery of drug to the lungs.

Patients should be made aware of the prophylactic nature of therapy with Becloforte and that, for optimum benefits, they should use it regularly, every day, even when they are asymptomatic.

Becloforte Inhaler is not designed to relieve acute asthmatic symptoms for which an inhaled short-acting bronchodilator is required. Patients should be advised to have such rescue medication available.

Severe asthma requires regular medical assessment, including lung function testing, as patients are at risk of severe attacks and even death.

Increasing use of bronchodilators, in particular short-acting inhaled Beta 2 agonists to relieve symptoms indicates deterioration of asthma control. If patients find that short acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought. In this situation patient should be reassessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroids or a course of oral corticosteroids). Severe exacerbations of asthma must be treated in the normal way.

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 and glaucoma. 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 recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Lack of response of severe exacerbations of asthma should be treated by increasing the dose of inhaled beclometasone dipropionate and, if necessary, by giving a systemic steroid and/or an antibiotic if there is an infection, and with Beta-agonist therapy.

 For the transfer of patients being treated with oral corticosteroids

The transfer of oral steroid-dependent patients to inhaled beclometasone dipropionate and their subsequent management needs special care as recovery from impaired adrenocortical function caused by prolonged systemic steroid therapy, may take a considerable time.

Patients who have been treated with systemic steroids for long periods of time or at a high dose may have adrenocortical suppression. With these patients adrenocortical function should be monitored regularly and their dose of systemic steroid reduced cautiously.

After approximately a week, gradual withdrawal of the systemic steroid is commenced. Decrements in dosages should be appropriate to the level of maintenance systemic steroid, and introduced at not less than weekly intervals. For maintenance doses of prednisolone (or equivalent) of 10mg daily or less, the decrements in dose should not be greater than 1mg per day, at not less than weekly intervals. For maintenance doses of predisolone in excess of 10mg daily, it may be appropriate to employ cautiously, larger decrements in dose at weekly intervals.

Some patients feel unwell in a non-specific way during the withdrawal phase despite maintenance or even improvement of the respiratory function. They should be encouraged to persevere with inhaled beclometasone dipropionate and to continue withdrawal of systemic steroid, unless there are objective signs of adrenal insufficiency.

Patients weaned off oral steroids whose adrenocortical function is impaired should carry a steroid warning card indicating that they may need supplementary systemic steroid during periods of stress e.g. worsening asthma attacks, chest infections, major intercurrent illness, surgery, trauma etc.

Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic drug. These allergies should be treated with antihistamine and/or topical preparations, including topical steroids.

Treatment with Becloforte Inhaler should not be stopped abruptly.

As with all inhaled corticosteroids, special care is necessary in patients with active quiescent pulmonary tuberculosis

Adverse Reactions

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common ( 1/10), common ( 1/100 and <1/10), uncommon ( 1/1000 and <1/100), rare ( 1/10,000 and <1/1000) and very rare ( <1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo and comparator group has not been taken into account in estimation of these frequencies. Rare and very rare events were generally determined from spontaneous data.

Candidiasis of the mouth and throat (thrush) occurs in some patients, the incidence of which is increased with doses greater than 400 micrograms beclometasone dipropionate per day. Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Patients may find it helpful to rinse out their mouth with water after using the inhaler. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with beclometasone dipropionate treatment.

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma.

In some patients inhaled beclometasone dipropionate may cause hoarseness or throat irritation. It may be helpful to rinse out the mouth with water immediately after inhalation. The use of a Volumatic spacer device may also be considered.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator. The beclometasone dipropionate preparation should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted.

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