Bronchial asthma

Active Ingredient: Budesonide

Indication for Budesonide

Population group: only children (1 year - 12 years old)

Treatment of persistent bronchial asthma in patients where use of a pressurised inhaler or dry powder formulation is unsatisfactory or inappropriate.

For this indication, competent medicine agencies globally authorize below treatments:

0.5-1 mg in 2 divided doses daily

Route of admnistration

Respiratory (Inhalation)

Defined daily dose

0.5 - 1 mg

Dosage regimen

From 0.25 To 0.5 mg 2 time(s) per day every day

Detailed description

The dose should be given twice daily. Administration once daily may be considered in cases of mild to moderate stable asthma.

Initial dosage

The initial dose should be tailored to the severity of the disease and thereafter should be adjusted on an individual basis. The following doses are recommended but the minimum effective dose should always be sought:

Children aged 6 months and above: 0.25–1.0mg daily. For patients in maintenance therapy with oral steroids a higher initial dosage up to 2.0 mg daily should be considered.

Maintenance dose

The maintenance dose should be adjusted to meet the requirements of the individual patient taking account of the severity of the disease and the clinical response of the patient. When the desired clinical effect has been obtained, the maintenance dose should be reduced to the minimum required for control of the symptoms.

Children aged 6 months and above: 0.25-1.0mg daily.

Administration once daily

Administration once daily should be considered for children and adults with mild to moderate stable asthma and with a maintenance dose between 0.25 mg and 1 mg budesonide daily. Once-daily administration may be initiated both in patients who are not receiving corticosteroid treatment and in well-controlled patients who are already taking inhaled steroids. The dose may be given in the morning or evening. If a worsening of the asthma occurs, the daily dose should be increased by administering the dose twice daily.

Onset of effect

An improvement of the asthma following administration of budesonide may occur within 3 days after initiation of therapy. The maximum effect will only be obtained after 2-4 weeks of treatment.

Patients in maintenance therapy with oral glucocorticosteroids

Budesonide nebuliser suspension may permit replacement or significant reduction in dosage of oral glucocorticosteroids while maintaining asthma control. When transferral from oral steroids to budesonide nebuliser suspension is started, the patient should be in a relatively stable phase. A high dose of budesonide nebuliser suspension is then given in combination with the previously used oral steroid dose for about 10 days. After that, the oral steroid dose should be gradually reduced (by for example 2.5 milligrams prednisolone or the equivalent each month) to the lowest possible level. In many cases, it is possible to completely substitute the oral steroid with budesonide nebuliser suspension. For further information on the withdrawal of corticosteroids. When tapering off systemic corticosteroids some patients will experience steroid withdrawal symptoms, e.g. joint and/or muscle pain, lack of energy and depression or even a decreased lung function. Such patients must be advised to continue the inhaled budesonide therapy, but they should also be examined for any objective signs of adrenocortical insufficiency. If such signs are present, the dose of the systemic corticosteroid should be temporarily increased and then tapered off even more slowly. In periods of stress or severe asthma attacks, patients in the transition phase may require treatment with systemic corticosteroids.

Active ingredient

Budesonide

Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers.

Read more about Budesonide

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