Corticosteroids (steroids).

Beclometasone [beclomethasone] dipropionate

Each actuation delivers beclometasone dipropionate 250?g (as propellant solvate) into the mouthpiece of the adapter

Pressurised aerosol for inhalation therapy.

Chronic reversible obstructive airways disease.

The dose should be titrated to the lowest dose at which effective control of asthma is maintained.

for maintenance: 2 inhalations (500 μg), twice daily or 1 inhalations (250 μg), four times daily, may be increased to 2 inhalations four times daily if necessary.

In patients receiving doses of 1500 µg or more daily, adrenal suppression may occur. The degree of suppression may not always be clinically significant but it is advisable to provide such patients with a supply of oral steroid to use in stressful situations. The risk of adrenal suppression occurring should be balanced against the therapeutic advantages.

AeroBec Forte Autohaler is not recommended for use in children.

No special dosage recommendations are made for elderly patients

Hypersensitivity to beclometasone is a contra-indication. Caution should be observed in patients with pulmonary tuberculosis.

Patients should be instructed on the proper use of the inhaler. They should be made aware of the prophylactic nature of Aerobec Autohaler therapy and that it should be used regularly at the intervals recommended and not when immediate relief is required.

In patients who have been transferred to inhalation therapy, systemic steroid therapy may need to be re-instated rapidly during periods of stress or where airways obstruction or mucus prevents absorption from the inhalation.

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 adolescents, decrease in bone mineral density, cataract and glaucoma. It is important therefore that the dose of inhaled steroid is titrated to the lowest dose at which effective control of asthma is maintained.

It is recommended that the height of adolescents 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.

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 transferred to beclometasone therapy. Recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy, is slow. The patient should be in a reasonably stable state before being given AeroBec Autohaler in addition to his usual maintenance dose of systemic steroid. Withdrawal of the systemic steroid should be gradual, starting after about seven days by reducing the daily oral dose by 1 mg prednisolone, or equivalent, at intervals not less than one week. Adrenocortical function should be monitored regularly.

Most patients can be successfully transferred to AeroBec Autohaler with maintenance of good respiratory function, but special care is necessary for the first months after the transfer until the hypothalamic-pituitary-adrenal (HPA) system has sufficiently recovered to enable the patient to cope with emergencies such as trauma, surgery or infections.

Patients who have been transferred to inhalation therapy should carry a warning card indicating that systemic steroid therapy may need to be re-instated without delay during periods of stress. It may be advisable to provide such patients with a supply of oral steroid to use in emergency, for example when the asthma worsens as a result of a chest infection. The dose of AeroBec Autohaler should be increased at this time and then gradually reduced to the maintenance level after the systemic steroid has been discontinued.

Discontinuation of systemic steroids may cause exacerbation of allergic diseases such as atopic eczema and rhinitis. These should be treated as required with antihistamine and topical therapy.

Candidiasis of the throat and mouth may develop in some patients, but this can be treated without discontinuation of beclometasone therapy. Hoarseness may also occur.

As with other inhaled therapy, paradoxical bronchospasm with wheezing may occur immediately after dosing. Immediate treatment with an inhaled short-acting bronchodilator is required. Aerobec Forte Autohaler should be discontinued immediately and alternative prophylactic therapy introduced.

Systemic effects of inhaled corticosteroids may occur particularly at high doses prescribed for prolonged periods. These may include adrenal suppression, growth retardation in adolescents, decrease in bone mineral density, cataract and glaucoma.

Hypersensitivity reactions including rashes, urticaria, pruritus and erythema and oedema of the eye, face, lips and throat (angioedema) have been reported.

Meda Pharmaceuticals Ltd

(POM)

04 June 2009