PULMICORT RESPULES

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

Dosage schedules:

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 Pulmicort 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 Initiation of therapy When treatment is started, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the recommended dose of Pulmicort Respules is: Adults (including the elderly): Usually 1 - 2 mg twice daily.

In very severe cases the dosage may be further increased.

Paediatric population Children 12 years and older:

Dosage as for adults. 5 – 1 mg twice daily. Maintenance The maintenance dose should be individualised and be the lowest dose which keeps the patient symptom-free. 5 - 1 mg twice daily. 5 mg twice daily. Patients maintained on oral glucocorticosteroids Pulmicort Respules may permit replacement or significant reduction in dosage of oral glucocorticosteroids while maintaining asthma control.

When transferral from oral steroids to Pulmicort Respules is started, the patient should be in a relatively stable phase. A high dose of Pulmicort Respules is then given in combination with the previously used oral steroid dose for about 10 days.

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 Pulmicort Respules. For further information on the withdrawal of oral corticosteroids, see section

Tabulated list of adverse reactions The following definitions apply to the incidence of undesirable effects: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

4). Description of selected adverse reactions The candida infection in the oropharynx is due to drug deposition. Advising the patient to rinse the mouth out with water after each dosing will minimise the risk. 4). Facial skin irritation, as an example of a hypersensitivity reaction, has occurred in some cases when a nebuliser with a face mask has been used.

To prevent irritation, the facial skin should be washed with water after use of the face mask. In placebo-controlled studies, cataract was also uncommonly reported in the placebo group. Clinical trials with 13119 patients on inhaled budesonide and 7278 patients on placebo have been pooled.

15% on placebo. 4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard.

4. 9% saline and with solutions for nebulisation of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium bromide. The admixture should be used within 30 minutes. 0 8 Where an increased therapeutic effect is desired, especially in those patients without major mucus secretion in the airways, an increased dose of Pulmicort Respules is recommended, rather than combined treatment with oral corticosteroids, because of the lower risk of systemic effects.

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

Method of administration Pulmicort respules should be administrated from suitable nebulisers. Instruction for correct use of Pulmicort 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. Pulmicort 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. 9% saline and with solutions for nebulisation of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate and ipratropium bromide.

The admixture should be used within 30 minutes. • to minimise the risk of oropharyngeal candida infection, the patient should rinse their mouth out with water after inhaling. 1. 4 Special warnings and precautions for use Special caution is necessary in patients with active or quiescent pulmonary tuberculosis and in patients with fungal or viral infections in the airways.

Non steroid-dependent patients:

A therapeutic effect is usually reached within 10 days. In patients with excessive mucus secretion in the bronchi, a short (about 2 weeks) additional oral corticosteroid regimen can be given initially. After the course of the oral drug, Pulmicort Respules alone should be sufficient therapy.

Steroid-dependent patients:

When transfer from oral corticosteroid to treatment with Pulmicort Respules is initiated, the patient should be in a relatively stable phase. Pulmicort Respules is then given, in combination with the previously used oral steroid dose, for about 10 days.

5 mg prednisolone or the equivalent each month), to the lowest possible level. In many cases, it is possible to completely substitute Pulmicort Respules for the oral corticosteroid. During transfer from oral therapy to Pulmicort Respules, a generally lower systemic corticosteroid action will be experienced, which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain.

Specific treatment should be initiated for these conditions. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.

As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase in wheezing after dosing. If this occurs, treatment with inhaled budesonide should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Patients, who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk of impaired adrenal function. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress.

Additional systemic corticosteroid treatment should be considered during periods of stress or elective surgery. Systemic effects may occur with any inhaled corticosteroids, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids.

Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained. Pulmicort Respules is not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required.

If patients find short-acting bronchodilator treatment ineffective, or they need more inhalations than usual, medical attention must be sought. In this situation consideration should be given to the need for […]

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