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Turbuhaler: 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" under Cautions for Usage.
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.
Respules: Bronchial asthma: PULMICORT RESPULES Nebulising Suspension: PULMICORT RESPULES should be administered from a suitable nebuliser. The dose delivered to the patient varies between 40-60% of the nominal dose depending on the nebulising equipment used. The nebulisation time and the dose delivered is dependent on flow rate, volume of nebuliser chamber and volume fill. A suitable fill for most nebulisers is 2-4 mL.
Some sedimentation may occur during storage of PULMICORT RESPULES. If this does not readily resuspend completely upon shaking, the RESPULE should be discarded.
Dosage initially, or during periods of severe asthma, or while reducing oral corticosteroids: Adults: 1-2 mg twice daily.
Children: 0.5-1 mg twice daily.
Maintenance: The maintenance dose should be individualised and should be the lowest dose, which keeps the patient symptom-free. Recommended doses are: Adults: 0.5-1 mg twice daily.
Children: 0.25-0.5 mg twice daily.
Patient Instructions: 1. It is essential that the patient be instructed that PULMICORT is a preventative agent, which must be taken regularly and is not to be used as sole therapy to relieve an acute asthma attack.
2. The patient should be instructed in the proper use of the inhaler device considered appropriate for his/her particular needs. A full set of instructions are provided with each pack of PULMICORT.
3. Patients also receiving bronchodilators by inhalation should be advised to use the bronchodilator before PULMICORT in order to enhance its penetration into the bronchial tree. Several minutes should elapse between the use of the two inhalers.
Clinical Management: Patients - not oral corticosteroid dependent: Treatment with the recommended doses of PULMICORT usually gives a therapeutic effect within 10 days.
In patients with excessive mucus secretion in the bronchi, an initial short course (about 2 weeks) of an oral corticosteroid, commencing with a high dose and gradually reducing, should be given in addition to PULMICORT. Treatment should be continued for at least one month before determining the maximal response to a given dose of PULMICORT.
Patients - oral corticosteroid dependent: Transfer of patients dependent on oral corticosteroids to PULMICORT requires special care because of slow normalisation of the disturbed hypothalamic-pituitary-adrenal function caused by extended treatment with oral corticosteroids (see Oral corticosteroid usage and Potential systemic effects of inhaled corticosteroids: HPA axis suppression and adrenal insufficiency under Precautions).
When PULMICORT treatment is initiated, the patient's asthma should be in a relatively stable phase. A high dose of PULMICORT should then be given in combination with the previously used oral corticosteroid dose for about 2 weeks. The dose of oral corticosteroid should then be reduced gradually (for example 1mg prednisolone or equivalent every four days, however, the exact rate of reduction will depend on individual clinical response) to the lowest possible level. The dose of PULMICORT should not be changed while the patient remains on oral corticosteroids.
In many cases, it may be possible to completely replace the oral corticosteroid with inhaled PULMICORT. In other patients, a low oral steroid maintenance dose may be necessary. Some patients may experience uneasiness during the withdrawal of oral corticosteroids due to the decreased systemic corticosteroid effect. The physician may need to actively support the patient and to stress the reason for the PULMICORT treatment.
The length of time needed for the body to regain sufficient natural corticosteroid production is often extended and may be as long as 12 months. Transferred patients should carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress, such as severe infection, trauma or surgery. During such times it may be necessary to give additional oral corticosteroids.
During transfer from oral therapy to PULMICORT, a lower systemic steroid action is experienced. Earlier allergic symptoms may recur (eg. rhinitis, eczema, conjunctivitis) or patients may suffer from tiredness, headache, muscle and joint pain, lassitude and depression or occasionally nausea and vomiting. In these cases, further medical support may be required.
