ClenilR ModuliteR 100 micrograms per actuation pressurised inhalation solution
Beclometasone dipropionate 100 micrograms per metered (ex-valve) dose
Pressurised inhalation solution
Clenil Modulite contains the new propellant HFA-134a and does not contain any chlorofluorocarbons (CFCs). The solution is clear and colourless.
Clenil Modulite is indicated for the prophylactic management of mild, moderate, or severe asthma in adults or children:
Mild asthma: Patients requiring intermittent 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
Posology and method of administration
Clenil Modulite is for inhalation use only. The Volumatic™ spacer device may be used by patients who have difficulty synchronising aerosol actuation with inspiration of breath.
The starting dose of inhaled beclometasone dipropionate should be adjusted to the severity of the disease. The dose may then be adjusted until control is achieved and then should be titrated to the lowest dose at which effective control of asthma is maintained.
Adults (including the elderly): The usual starting dose is 200 micrograms twice daily. In severe cases this may be increased to 600 to 800 micrograms daily. This may then be reduced when the patient's asthma has stabilised. The total daily dosage should be administered as two to four divided doses.
The Volumatic™ spacer device must always be used when Clenil Modulite is administered to adults and adolescents 16 years of age and older taking total daily doses of 1000 micrograms or greater.
Children: The usual starting dose is 100 micrograms twice daily. Depending on the severity of asthma, the daily dose may be increased up to 400 micrograms administered in two to four divided doses.
Clenil Modulite must always be used with the Volumatic™ spacer device when administered to children and adolescents 15 years of age and under, whatever dose has been prescribed.
Patients with hepatic or renal impairment: No dosage adjustment is needed in patients with hepatic or renal impairment.
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