INFORMATION FOR HEALTH PROFESSIONALS
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RESPOCORT AUTOHALERS are breath-activated metered dose inhalers containing a homogeneous aerosol suspension of micronised beclomethasone dipropionate in a blend of chlorofluorocarbon propellants. The suspension is contained within a pressurised 10 ml aluminium vial closed with a metering valve and fitted with a plastic oral adaptor. The valve mechanism is actuated by negative pressure applied during the inspiration phase.
Inhaled beclomethasone is now a well established treatment for the management of asthma. It is a synthetic glucocorticoid and exerts a topical anti-inflammatory effect in the lungs.
Approximately 20% of the inhaled dose reaches the lungs. About 75% of the delivered dose is absorbed by the lung. The beclomethasone absorbed directly from the lungs is converted to less active metabolites during its passage through the liver and is excreted in the urine. Peak plasma concentrations are reached 3 to 5 hours following inhalation.
RESPOCORT AUTOHALER is indicated for the prophylactic treatment of chronic reversible obstructive airways disease, such as asthma. RESPOCORT AUTOHALER is indicated for a wide range of patients with bronchial asthma. These patients include those whose asthma is becoming worse and the relief provided by bronchodilators is less effective, those who are inadequately controlled by sodium cromoglycate in addition to bronchodilators and those with severe asthma who are dependent on systemic corticosteroids or adrenocorticotrophic hormone (ACTH) or its synthetic equivalent. RESPOCORT Forte AUTOHALER is appropriate for treatment of patients requiring higher doses to control their symptoms.
The maintenance dose is individual and should be the lowest dose which keeps the patient symptom-free. Administration twice daily is often adequate in patients with asthma in a stable phase.
No special dosage recommendations are made for elderly patients.
Patients should be made aware of the preventive nature of treatment with inhaled beclomethasone dipropionate and that it should be taken regularly as advised by their doctor, even when they are asymptomatic.
If even higher doses of RESPOCORT AUTOHALER are used, clinical benefit and the risk of systemic effects from higher doses of RESPOCORT AUTOHALER should be weighed against the risks associated with high doses of oral corticosteroids. It is advisable to check compliance and inhaler technique before increasing the dose.
There are no specific contraindications, but caution should be used in patients with active or quiescent tuberculosis or in those with known hypersensitivity to beclomethasone.
Patients should be educated regarding the correct use of RESPOCORT AUTOHALER to ensure that the medicine reaches the target sites within the lungs. Patients should be made aware that RESPOCORT AUTOHALER must be used regularly as instructed, and not when immediate relief is required, to obtain optimum benefit.
When appropriate, patients previously treated with systemic corticosteroids may be transferred to inhalation treatment with beclomethasone. The transfer of steroid-dependent patients to beclomethasone therapy and the subsequent management of such patients requires special care, mainly because recovery from impaired adrenocortical function, caused by prolonged use of systemic corticosteroid therapy, is slow. The patient should be reasonably stable before being given RESPOCORT AUTOHALER in addition to the usual maintenance dose of systemic corticosteroid. After about a week, gradual withdrawal of the systemic corticosteroid should be started by reducing the daily dose by 1 mg prednisone, or the equivalent dose of other corticosteroids, at not less than weekly intervals.
In patients who have been transferred to beclomethasone inhalation therapy, systemic therapy may need to be re-instated without delay during periods of stress or where use of RESPOCORT AUTOHALER is compromised. Many patients can be transferred successfully to RESPOCORT AUTOHALER with maintenance of good respiratory function, but special care is necessary for the initial months after transfer until the pituitary-adrenal system has recovered sufficiently to enable the patient to cope with emergencies such as trauma, surgery and infections. Respiratory tract infections should be treated with appropriate antimicrobial therapy.
Replacement of systemic corticosteroid treatment with RESPOCORT AUTOHALER sometimes unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic treatment. These allergies should be treated symptomatically using antihistamine and/or topical preparations.
This product contains chlorofluorocarbon propellants which have been associated with cardiotoxicity in some animal species.
Corticosteroids may cause growth retardation in infancy, childhood and adolescence. Treatment should be limited to the minimum dose in order to minimise suppression of the hypothalamic pituitary adrenal (HPA) axis and growth retardation.
There is inadequate evidence of safety in human pregnancy. In animals, systemic administration of relatively high doses can cause abnormalities of foetal development including growth retardation and cleft palate. There may therefore be a very small risk of such effects in the human foetus. However, inhalation of beclomethasone dipropionate into the lungs avoids the high level of exposure that occurs with the administration of systemic corticosteroids.
The use of beclomethasone dipropionate in pregnancy requires that the possible benefits of the drug be weighed against the possible hazards. The drug has been in widespread use for many years without apparent ill consequence.
It is probable that beclomethasone is excreted in breast milk. However, given the relatively low doses used by the inhalation route, the levels are likely to be low. In mothers who are breast feeding, the therapeutic benefits of the drug should be weighed against the potential hazards to mother and baby.
HPA axis suppression may occur at high doses with regular treatment. Reduction of plasma cortisol levels has been reported in patients who have received twice the recommended dose of beclomethasone. In the event of excessive intake of beclomethasone for weeks or months, a degree of adrenocortical atrophy could occur in addition to suppression of HPA function. This effect is not usually found in adults with daily treatment of less than 1500 mcg per day. Depending on age for children this is not usually found with daily treatment of less than 400 to 800 mcg/day.
Candidiasis of the throat and mouth or hoarseness may develop in some patients, but this can be treated with antifungal agents without cessation of beclomethasone therapy and by the use of a spacer device to reduce local absorption.
No clinically significant drug interactions have been associated with therapeutic doses of beclomethasone.
If grossly excessive doses of beclomethasone dipropionate were taken over a prolonged period a degree of atrophy of the adrenal cortex could occur in addition to HPA suppression.
In this event the patient should be treated as steroid-dependent and transferred to a suitable maintenance dose of a systemic corticosteroid such as prednisone. Once the condition is stabilised the patient should be returned to RESPOCORT AUTOHALER by the method recommended above. To guard against the unexpected occurrence of adrenal suppression regular tests of adrenal function are advised.
Store in a cool, dry place below 30°C, protected from frost and direct sunlight. As the vial is pressurised, no attempt should be made to puncture or dispose of it by burning.
Prescription Medicine
3M Pharmaceuticals
a division of 3M New Zealand Limited
P.O. Box 2201 Shortland Street
AUCKLAND
Telephone: (09) 444 5289
Facsimile: (09) 444 5770
30 June 1999
™RESPOCORT, AUTOHALER and 3M are registered trademarks.