PULMICORT TURBUHALER 200 MCG/DOSE [SIN05042P]

Product Info

PULMICORT TURBUHALER 200 MCG/DOSE

[SIN05042P]

4.1 Therapeutic indications

Pulmicort Turbuhaler is indicated for patients with bronchial asthma who require maintenance treatment with glucocorticosteroids for control of the underlying airways inflammation.

4.2 Posology and method of administration

The dosage of Pulmicort Turbuhaler is individual.
Initially, at 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 Pulmicort Turbuhaler is prophylactic therapy with no demonstrated effect on acute disorders.

Clinical trials indicate that a larger amount of budesonide is deposited in the lungs when administered with Pulmicort Turbuhaler, compared with Pulmicort pMDI. If a patient in a stable phase is transferred from Pulmicort pMDI to Pulmicort Turbuhaler a reduction in dose may therefore be appropriate.

In patients in whom an increased therapeutic effect is desired, in general an increase of the Pulmicort Turbuhaler dose is to be recommended in preference to combination treatment with oral corticosteroids on account of the lower risk of systemic side effects.

Patients dependent on oral steroids:
When transfer from oral steroids to Pulmicort Turbuhaler is initiated the patient must be in a relatively stable condition. For 10 days, a high dose of Pulmicort Turbuhaler is given in combination with the previously used oral steroid. 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 of 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.

Instructions for correct use of Turbuhaler

It is important that the inhaler is used correctly.

Turbuhaler is inspiratory flow-driven which means that, when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.

Note It is important to instruct the patient

• To carefully read the instructions for use: “How to use Pulmicort Turbuhaler”

• To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs

• Never to breathe out through the mouthpiece

• To rinse the mouth out with water after inhaling the prescribed dose to minimise the risk of oropharyngeal thrush

The patient may not taste or feel any medication when using Pulmicort Turbuhaler due to the small amount of drug dispensed.

4.3 Contraindications

Hypersensitivity to budesonide.