INHALATION SUSPENSION

20 STERILE UNIT DOSE AMPOULES

MECHANISM OF ACTION

Budesonide is a glucocorticosteroid with a powerful local anti-inflammatory action.

The precise mechanism of action of glucocorticosteroids in the treatment of asthma is not fully understood. Anti-inflammatory effects (including T-cells, eosinophilic cells and mast cells) such as inhibition of the release of inflammatory mediators and inhibition of cytokine-mediated immune response, are probably important.

THERAPEUTIC INDICATIONS

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

• Very serious pseudocroup (laryngitis subglottica) in which hospitalization is indicated.

DOSING AND ADMINISTRATION

Posology

Asthma

- Initial dosage:

• Children aged 6 months and above:

o 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.

• Adults (including the elderly) and children/adolescents over 12 years of age:

o 0.5 - 2 mg daily. In very severe cases the dosage may be increased further.

- Maintenance dose:

• Children aged 6 months and above:

o 0.25 - 1.0mg daily.

• Adults (including the elderly) and children/adolescents over 12 years of age:

o 0.5 - 2.0mg daily. In very severe cases the dose may be further increased

Pseudocroup

In infants and children with pseudocroup, the commonly used dose is 2 mg of nebulised budesonide. This is given as a single administration, or as two 1 mg doses separated by 30 minutes. Dosing can be repeated every 12 hours for a maximum of 36 hours or until clinical improvement.