Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Breath Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom
Treatment of persistent bronchial asthma in patients where use of a pressurised inhaler or dry powder formulation is unsatisfactory or inappropriate.
Very serious pseudocroup (laryngitis subglottica) in which hospitalisation is indicated.
The dose should be given twice daily.
Administration once daily may be considered in cases of mild to moderate stable asthma.
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.
Adults (including the elderly) and children/adolescents over 12 years of age: 0.5-2 mg daily. In very severe cases the dosage may be increased further.
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.
Adults (including the elderly) and children/adolescents over 12 years of age: 0.5-2.0mg daily. In very severe cases the dose may be further increased.
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.
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.
Asthma:
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, see section 4.4.
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.
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.
For inhalation use only.
Dosage schedule:
| Dosage in mg | Volume of Budesonide Nebuliser Suspension | |
|---|---|---|
| 0.25 mg/ml | 0.5 mg/ml | |
| 0.25 | 1 ml* | - |
| 0.5 | 2 ml | - |
| 0.75 | 3 ml | - |
| 1 | - | 2 ml |
| 1.5 | - | 3 ml |
| 2 | - | 4 ml |
* Should be mixed with 0.9% saline to a volume of 2 ml.
The contents of the single-dose container may be divided for adjustment of the dose.
Half the ampoule contents should be placed in the nebuliser cup and mixed with an equal volume of 0.9% sodium chloride solution. To ensure accurate dosing the use of a measuring syringe is recommended.
Budesonide Nebuliser Suspension may be mixed with 0.9% sodium chloride solution and with solutions for inhalation containing terbutaline, salbutamol, sodium cromoglycate or ipratropium.
Budesonide Nebuliser Suspension must be administered with a jet nebuliser supplied with a mouthpiece or mask. The nebuliser should be connected to an air compressor with adequate air flow (5-8 l/min), and the filling volume should be 2-4 ml.
There can be variation in the performance (dose delivered) between nebulizers, even those of the same make and model.
Note: Ultrasound nebulisers are not suitable for nebulisation of Budesonide Nebuliser Suspension and therefore cannot be recommended.
The spray container should be shaken before use.
To minimise the risk of oropharyngeal candida infection, the patient should rinse their mouth out with water after inhaling.
To prevent irritation of the facial skin the face should be washed after using the nebuliser with a mask.
The nebuliser should be cleaned after each use.
Wash the nebuliser container and mouthpiece or face-mask in warm water using a mild detergent in accordance with the manufacturer’s instructions. Rinse well and dry it by connecting the nebuliser container to the compressor or the air inlet.
Acute overdose with budesonide usually does not constitute a clinical problem. The only harmful effect after a large amount of sprays during a short period is a suppression of the cortex function.
If it is a matter of chronic use of very high doses, effects such as a degree of cortex atrophy in addition to adrenocortical suppression may occur.
There is no need for acute measures. The treatment with budesonide should be continued with the lowest possible effective maintenance dose, and the adrenocortical function will repair itself automatically within 1-2 days.
The patient should be treated as a steroid dependent and be transferred to a suitable maintenance dose with a systemic steroid, for example prednisolone. When the condition is stabilized, the patient should continue the treatment with the inhalation of budesonide at the recommended dose.
Shelf life: 3 years.
After first opening of the foil sachet, the ampoule may be stored unopened for three months.
Use ampoule within 12 hours of opening.
Store in the original package in order to protect from light and moisture.
Low density polyethylene ampoule containing 2ml nebuliser suspension.
Pack sizes: Tri-laminate foil sachets containing 5, 20, 24, 40 (2 × 20) and 60 ampoules (in strips of 4, 5, 8, 10 or 12 ampoules).
Not all pack sizes may be marketed.
Budesonide nebuliser suspension can be mixed with 0.9% saline and with solutions of terbutaline, salbutamol, sodium chromoglycate, or ipratropium bromide.
For single use only. Any unused solution should be discarded.
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