Decomit 100

Beclometasone 50, 100 & 250 HFA Inhaler is indicated in the prophylactic management of mild, moderate, or severe asthma in adults or children. 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.

Mild asthma: Patients requiring symptomatic bronchodilator asthma medication on a regular basis.

Moderate asthma: Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone.

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.

Respiratory corticosteroids

Beclomethasone dipropionate produces anti-inflammatory and vasoconstrictor effects. The mechanisms responsible for the anti-inflammatory action of beclomethasone dipropionate are unknown. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. The direct relationship of these findings to the effects of beclomethasone dipropionate on allergic rhinitis symptoms is not known.

Biopsies of nasal mucosa obtained during clinical studies showed no histopathologic changes when beclomethasone dipropionate was administered intranasally.

Beclomethasone dipropionate is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolyzed via esterase enzymes to its active metabolite beclomethasone-17-monopropionate (B-17-MP), which has high topical anti inflammatory activity.

Beclometasone dipropionate Inhaler is for oral inhalation use only. Patients should be given a starting dose of inhaled beclometasone dipropionate appropriate to the severity of their disease. The dose may then be adjusted until control is achieved, or reduced to the minimum effective dose according to individual response.

Adults (including the elderly): The usual starting dose is 200 micrograms twice a day. In more severe cases the starting dose may need to increase to 600 to 800 micrograms per day which 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

Children: 50 to 100 micrograms should be given two, three or four times daily in accordance to the response. Alternatively, 100 micrograms or 200 micrograms twice daily should be given. The usual starting dose is 100 micrograms twice daily. Beclometasone 250 Inhaler is not recommended for children.

Beclometasone 250 HFA Inhaler: The usual starting dose is 200 micrograms twice a day. In more severe cases the starting dose may need to increase to 600 to 800 micrograms per day which 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.

There is no need to increase the dose in patients with hepatic or renal impairment.

Hypersensitivity to any of the components. Special care is necessary in patients with active or quiescent pulmonary tuberculosis.

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

There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation.

The use of beclometasone dipropionate in mothers breast feeding their babies requires that the therapeutic benefits of the drug be weighed against the potential hazards to the mother and baby.