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Drug Details

Asmabec Clickhaler 50, 100, 250

• Generic Name
  Beclometasone [beclomethasone] dipropionate
• Presentation
  Each metered actuation of 1.3mg contains 50 micrograms of beclometasone dipropionate and delivers 45 micrograms of beclometasone dipropionate. Each metered actuation of 2.6mg contains 100 micrograms of beclometasone dipropionate and delivers 90 micrograms of beclometasone dipropionate. Each metered actuation of 6.6mg contains 250 micrograms of beclometasone dipropionate and delivers 225 micrograms of beclometasone dipropionate.
• Description
  Asmabec Clickhaler 50 micrograms. Inhalation powder Asmabec Clickhaler 100micrograms. Inhalation powder Asmabec Clickhaler 250micrograms. Inhalation powder
• Indications
  

  Beclometasone Dipropionate is indicated for the control of persistent asthma.

• Adult Dosage
  

  The product is intended for oral inhalation only. For optimum results Asmabec Clickhaler should be used regularly.

  The initial dose should be appropriate to the severity of the disease and the maintenance dose titrated to the lowest dose at which effective control of asthma is achieved.

  The initial dose for patients with mild asthma is 200 to 400 micrograms per day; this may be increased to 800 micrograms per day if required.

  For patients with moderate asthma and severe asthma the initial dose can be 800 to 1600 micrograms per day, increased to 2000 micrograms in severe cases. The normal maximum daily dose for adults is 2000 micrograms.

  The maintenance dose is normally 200 to 400 micrograms twice daily. If necessary the dose may be increased to 1600 to 2000 micrograms per day divided into two to four doses and be reduced later when asthma is stabilised.

• Child Dosage
  

  Up to 100 micrograms 2 to 4 times daily according to the clinical response.

  Normally the maximum daily dose in children is 400μg. However some cases of severe asthma may not be controlled and higher doses may be required in line with international guidelines. Once the asthma is controlled, the dose of Asmabec Clickhaler should be reduced to the minimum to maintain control.

  When transferring a patient to Asmabec Clickhaler from other devices, treatment should be individualised taking into consideration the active ingredient and method of administration.

• Contra Indications
  

  Asmabec Clickhaler is contra-indicated in patients with hypersensitivity (allergy) to beclometasone dipropionate or to the excipient

• Special Precautions
  

  Patients should be instructed in the proper use of the inhaler. They should also be made aware of the prophylactic nature of therapy with Asmabec Clickhaler and that they should use it regularly, every day, even when they are asymptomatic. Beclometasone dipropionate is not suitable for the treatment of an acute asthma attack.

  Increasing use of bronchodilators, in particular short-acting inhaled β₂-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 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. Possible systemic effects include 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 steroids 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 steroids 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 symptoms is achieved.

  Doses in excess of 1500 micrograms per day may induce adrenal suppression. In such patients the risks of developing adrenal suppression should be balanced against the therapeutic advantages, and precautions should be taken to provide systemic steroid cover in situations of stress or elective surgery.

  The transfer to inhaled beclometasone dipropionate of patients who have been treated with systemic steroids for long periods of time, or at high dose, needs special care and subsequent management as recovery from impaired adrenocortical function is slow. With these patients adrenocortical function should be monitored regularly and their dose of systemic steroid reduced cautiously. Gradual withdrawal of the systemic steroid should commence after about one week. Reductions in dosage, appropriate to the level of maintenance systemic steroid, should be introduced at not less than weekly intervals.

  Some patients may feel unwell in a non-specific way during withdrawal of the systemic steroid. They should be encouraged to persevere with the inhaled beclometasone dipropionate, unless there are objective signs of adrenal insufficiency.

  Patients who have been transferred from oral steroids whose adrenocortical function is impaired should carry a steroid warning card indicating that they may need supplementary systemic steroids during periods of stress, eg. 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.

  In the case of massive mucus secretion in the respiratory tract, de-obstruction and a short course of oral steroids may be necessary to ensure efficacy of the inhaled beclometasone.

  Special care is necessary in patients with active or quiescent pulmonary tuberculosis and in patients with viral, bacterial and fungal infections of the eye, mouth or respiratory tract. In the case of bacterial infection of the respiratory tract adequate antibiotic co-medication may be required.

  Treatment with Asmabec Clickhaler especially at high doses should not be stopped abruptly.

  The presence of lactose may trigger hypersensitivity reactions, including bronchospasm, in patients with a known hypersensitivity to milk proteins.

• Interactions
  

  Due to the very low plasma concentration achieved after inhaled dosing, clinically significant drug interactions are in general unlikely. Care should be taken when co-administering known strong CYP 3A4 inhibitors (e.g. ketoconazole, itraconazole, nelfinavir, ritonavir) as there is a potential for increased systemic exposure to beclomethasone.

• Adverse Drug Reactions
  

  Infections and infestations: candidiasis of the mouth and throat. This may be treated whilst still continuing with Asmabec Clickhaler.

  Immune system disorders: easy bruising of the skin, very rarely hypersensitivity including rash and angioedema may occur.

  Endocrine disorders: decrease in bone mineral density, adrenal suppression, growth retardation in children and adolescents

  Psychiatric disorders: anxiety, sleep disorders, behavioural changes, including hyperactivity and irritability (predominately seen in children)

  Eye disorders: cataract and glaucoma

  Respiratory, thoracic and mediastinal disorders: hoarseness, paradoxical bronchospasm. If bronchospasm occurs the preparation should be discontinued immediately and if necessary alternative therapy instituted.

  It is recommended to rinse out the mouth thoroughly with water immediately after inhalation in order to reduce the risks of candidiasis and hoarseness.

  Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods.