Frenolyn Dosage/Direction for Use

The dosage of Frenolyn Miat-Haler is individual. Initially, of the beginning of inhaled corticosteroid therapy, for therapy during periods of severe asthma or when scaling down or withdrawing oral corticosteroids the dosage should be: Children 5 - 7 years: 200 - 400 micrograms daily divided into 2 - 4 administrations.
Children 7 years and more: 200 - 800 micrograms daily divided into 2 - 4 administrations.
Adults: 200 - 1600 micrograms daily divided into 2 - 4 administrations, (less severe cases 200 - 800 micrograms daily, more severe cases 800 - 1600 micrograms daily).
Administration twice daily (morning and evening) is usually sufficient.
The maintenance dose is individual and should be the lowest possible. When the maintenance dose is 400 micrograms or lower the dose can be given once daily. The dose may then be given in the morning or in the evening. If deterioration of asthma occurs, the frequency of dosing and the daily dose should be increased.
Following a single dose, an effect may be expected after a few hours. The full therapeutic effect is only achieved after a few weeks of treatment. Treatment with Frenolyn Miat-Haler is prophylactic therapy with no demonstrated effect on acute disorders.
In patients in whom an increased therapeutic effect is desired, in general, an increase of the Frenolyn Miat-Haler dose is to be recommended in preference to combination treatment with corticosteroids because of the lower risk of systemic side effects.
Patients dependent on oral steroids: When transfer from oral steroids is initiated the patient must be in a relatively stable condition. A high dose of Frenolyn is given in combination with the previous used oral steroid dose for 10 days. After that, the oral dose should be gradually reduced by e.g. 2.5 mg prednisolone or equivalent per month to the lowest possible level. The oral steroid can often be discontinued entirely.
There is no experience of treatment in patients with impaired hepatic or renal function. Since budesonide is predominantly eliminated through hepatic metabolism, increased exposure may be expected in patients with severe cirrhosis of the liver.