| Patients should be instructed in the proper use of the inhaler, and their technique checked, to ensure that the drug reaches the target areas within the lungs. They should also be made aware that Pulvinal Beclometasone Dipropionate has to be used regularly, every day, even when they are asymptomatic, if so advised.Pulvinal Beclometasone Dipropionate is not designed to relieve acute asthma symptoms for which an inhaled short-acting bronchodilator is required. Patients should be advised to have such relief medication available.Increasing use of bronchodilators, in particular short-acting inhaled beta2 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 patients should be reassessed and consideration given to the need or 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.Treatment with Pulvinal Beclometasone Dipropionate should not be stopped abruptly.Significant adrenal suppression rarely occurs before doses of 1500 micrograms per day of inhaled beclometasone dipropionate are exceeded. Reduction of plasma cortisol levels has been reported in some patients taking 2000 micrograms per day. In such patients, the risks of developing adrenal suppression should be balanced against the therapeutic advantages, and precautions taken to provide systemic steroid cover in situations of prolonged stress (e.g. elective surgery). Prolonged suppression of the hypothalamic-pituitary-adrenal (HPA) axis may eventually lead to systemic effects, including growth retardation in children and adolescents, decrease in bone mineral density, Cushing syndrome, Cushingoid features, cataract, glaucoma and more rarely a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important therefore that the dose of inhaled steroid is titrated to the lowest dose at which effective control of symptoms is achieved. 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.The transfer to Pulvinal Beclometasone Dipropionate of patients who have been treated with systemic steroids for long periods of time, or at a high dose, needs special care, since recovery from any adrenocortical suppression sustained may take a considerable time. Approximately one week after initiating treatment with Pulvinal Beclometasone Dipropionate, reduction of the dose of systemic steroid can be commenced. The size of the reduction should correspond to the maintenance dose of systemic steroid. Adrenocortical function should be monitored regularly as the dose of systemic steroid is gradually reduced.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 symptomatically treated with antihistamines and/or topical preparations, including topical steroids.As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis, in patients with viral, bacterial & fungal infection of the eye, mouth or respiratory tract. In the case of bacterial infection of the respiratory tract adequate antibiotics co-medication will be required.This product contains approximately 25mg of lactose monohydrate per dose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. | |
