Posology : מינונים

4.2 Posology and method of administration
Posology
Dosage schedules: Budicort Respules should be administered from suitable nebulisers.
The dose delivered to the patient varies depending on the nebulising equipment used. The nebulisation time and the dose delivered is dependent on flow rate, volume of nebuliser chamber and fill volume. An air-flow rate of 6 - 8 litres per minute through the device should be employed. A suitable fill volume for most nebulisers is 2 - 4 ml. The dosage of Budicort Respules should be adjusted to the need of the individual. The dose should be reduced to the minimum needed to maintain good asthma control. The highest dose (2 mg per day) for children under 12 years should only be considered in children with severe asthma and during limited periods.

Bronchial asthma
Administration can be once or twice daily. Once daily administration can be used for daily doses of 0.25 – 1 mg

Initiation of therapy
When treatment is started, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the recommended dose of Budicort Respules is: 
Adults (including elderly): Usually 1 – 2 mg total daily dose. In very severe cases the dosage may be increased.
Children 12 years and older: Dosage as for adults.

Children 6 months to 12 years: 0.25 – 0.5 mg total daily dose. In patients depending on oral glucocorticosteroids, a higher starting dose, e.g. 1 mg total daily dose may be considered.
Maintenance
The maintenance dose should be individualised and be the lowest dose which keeps the patient symptom-free.

Adults (including elderly and children 12 years and older): 0.5 - 4 mg total daily dose.
In very severe cases the dose may be further increased.

Paediatric population
Children 6 months to 12 years: 0.25 - 2 mg total daily dose.

Once Daily Dosing
Once daily dosing may be considered both in adult and in pediatric patients who require a maintenance dose of 0.25 to 1 mg budesonide per day. Once daily administration can be initiated both in non-corticosteroid treated patients and in patients well-controlled by inhaled corticosteroids. The dose can be administered either in the morning or evening. If deterioration of asthma occurs, the dose should be increased and divided over the day as necessary.

Following a single dose an effect may be expected after a few hours. The full therapeutic effect is achieved only after several weeks of treatment. Treatment with Budicort 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 Budicort dose is to be recommended in preference to combination treatment with oral corticosteroids on account of the lower risk of systemic side effects.

Patients maintained on oral glucocorticosteroids
Budicort Respules may permit replacement or significant reduction in dosage of oral glucocorticosteroids while maintaining asthma control. For further information on the withdrawal of oral corticosteroids, see section 4.4.

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 Budicort is given in combination with the previously 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.

Since budesonide given as Budicort suspension for nebuliser is deposited in the lungs with the aid of inspiration, it is important that the patient inhales calmly and with even breaths through the mouthpiece of the nebuliser.

There is no experience of treatment of patients with impaired hepatic or renal function.
Since budesonide is eliminated predominantly through metabolism in the liver, increased exposure may be expected in patients with severe cirrhosis of the liver.

A face-mask can be used for children who cannot breathe in through the mouthpiece.

Dose division and miscibility

Page 2 of 15
Budicort Respules can be mixed with 0.9% saline and with solutions for nebulisation of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium bromide.

Recommended Dosage Table
Budicort Respules 1 mg nebuliser solution (0.5 mg/ml)

Dose (mg)                           Volume (ml)
0.25                                -
0.5                                 1
0.75                                -
1.0                                 2
1.5                                 3
2.0                                 4

Where an increased therapeutic effect is desired, especially in those patients without major mucus secretion in the airways, an increased dose of Budicort is recommended, rather than combined treatment with oral corticosteroids, because of the lower risk of systemic effects.



Instruction for correct use of Budicort Respules
The Respule should be detached from the strip, shaken gently and opened by twisting off the wing tab. The contents of the Respule should be gently squeezed into the nebuliser cup. The empty Respule should be thrown away and the top of the nebuliser cup replaced.
Budicort Respules should be administered via a jet nebuliser equipped with a mouthpiece or suitable face mask. The nebuliser should be connected to an air compressor with an adequate air flow (6-8 L/min), and the fill volume should be
2-4ml.


Budicort nebuliser suspension is inhaled with the aid of a jet nebuliser fitted with a mouthpiece or suitable face-mask.

Ultrasonic nebulisers must not be used, as they deliver too low a dose of budesonide to the patient.

The nebuliser and compressor (propeller unit) must be adjusted so that the majority of the delivered drops of liquid are in the range of 3 to 5 micrometres.

An in-vitro study has shown that nebulisers of the types Pari Inhalierboy, Pari Master and Aiolos deliver comparable doses of budesonide.

The amount of budesonide delivered to a patient varies between 11 and 22 % of the amount administered in the nebuliser, and depends on factors such as
Page 3 of 15
    -     nebulisation time

-     volume fill

-     technical performance of the compressor (propeller unit) and the nebuliser 
-     patient’s tidal volume

-     use of face-mask or mouthpiece.
The air-flow rate through the nebuliser is also important. In order to obtain the maximum available dose of budesonide a flow rate of 5-8 l/min is required. The fill volume should be 2- 4 ml.

The available dose for small children is maximised by the use of a closely fitting face- mask.

The single-dose unit must be shaken carefully before being opened.

The nebuliser chamber must be cleaned after every administration. Wash the chamber and mouthpiece or face-mask with warm tap water and use a mild detergent.

Rinse thoroughly and dry the chamber by connecting it to the compressor or air inlet.

See also the nebuliser manufacturer’s instructions.

Note: It is important to instruct the patient

To carefully read the instructions for use in the patient information leaflet which are packed together with each nebuliser.


That Ultrasonic nebulisers are not suitable for the administration of Budicort Respules and therefore are not recommended.


Budicort Respules can be mixed with 0.9% saline and with solutions for nebulisation of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate and ipratropium bromide.

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

To wash the facial skin with water after using the face mask to prevent irritation.

To adequately clean and maintain the nebuliser according to the manufacturer’s instructions.

The dosage of Budicort Respules should be adjusted to the need of the individual.

Page 4 of 15
To carefully read the instructions for use in the patient information leaflet which are packed together with each nebuliser.