Loading…
PULMICORT TURBOHALER is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Pulmicort is recommended in patients with bronchial asthma.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology When transferring patients to Turbohaler from other devices, treatment should be individualised, whether once or twice daily dosing is being used. The drug and method of delivery should be considered.
Divided doses (twice daily):
The dosage should be individualised. The dose should always be reduced to the minimum needed to maintain good asthma control.
Adults (including the elderly) and children over 12 years of age:
When starting treatment, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the dosage in adults should be 200 - 1600 micrograms daily, in divided doses. In less severe cases and children over 12 years of age, 200 - 800 micrograms daily, in divided doses, may be used.
During periods of severe asthma, the daily dosage can be increased to up to 1600 micrograms, in divided doses. Children 5 - 12 years of age: 200 - 800 micrograms daily, in divided doses. During periods of severe asthma, the daily dose can be increased up to 800 micrograms.
Once daily dosage:
The dosage should be individualised. The dose should always be reduced to the minimum needed to maintain good asthma control. Adults (including the elderly) and children over 12 years of age: 200 micrograms to 400 micrograms may be used in patients with mild to moderate asthma who have not previously received inhaled glucocorticosteroids.
g. budesonide or beclomethasone dipropionate), administered twice daily. g. budesonide or beclomethasone dipropionate), administered twice daily. The patient should be transferred to once daily dosing at the same equivalent total daily dose; the drug and method of delivery should be considered.
The dose should subsequently be reduced to the minimum needed to maintain good asthma control. Patients should be instructed to take the once daily dose in the evening. It is important that the dose is taken consistently and at a similar time each evening.
There are insufficient data to make recommendations for the transfer of patients from newer inhaled steroids to once daily Pulmicort Turbohaler. g. increased frequency of bronchodilator use or persistent respiratory symptoms) they should double their steroid dose, by administering it twice daily, and should contact their doctor as soon as possible.
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) and not known (cannot be estimated from the available data).
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). 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. Patients should be reminded of the importance of taking prophylactic therapy regularly, even when they are asymptomatic. A short-acting inhaled bronchodilator should be made available for the relief of acute asthma symptoms. Method of administration Pulmicort Turbohaler is for oral inhalation.
Turbohaler 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 in the patient information leaflet, which is packed with each Turbohaler • 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 minimise the risk of oropharyngeal candida infection, the patient should rinse their mouth out with water after inhaling.
The patient may not taste or feel any medication when using Turbohaler due to the small amount of drug dispensed. 3 Contraindications Hypersensitivity to the active substance. 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.
Steroid-dependent patients:
When transferral from oral steroids to Pulmicort Turbohaler is started, the patient should be in a relatively stable phase. A high dose of Pulmicort Turbohaler is then given in combination with the previously used oral steroid dose for about 10 days.
Hypersensitivity to the active substance.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Budesonide in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
In patients where an increased therapeutic effect is desired, an increased dose of Pulmicort is recommended because of the lower risk of systemic effects as compared with a combined treatment with oral glucocorticosteroids. Patients maintained on oral glucocorticosteroids Pulmicort Turbohaler may permit replacement or significant reduction in dosage of oral glucocorticosteroids while maintaining asthma control.
When transferral from oral steroids to Pulmicort is started, the patient should be in a relatively stable phase. A high dose of Pulmicort 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. For further information on the withdrawal of oral corticosteroids, see section
5 milligrams prednisolone or the equivalent each month) to the lowest possible level. In many cases, it is possible to completely substitute Pulmicort for the oral steroid. During transfer from oral therapy to Pulmicort, a generally lower systemic steroid 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. During the withdrawal of oral steroids, patients may feel unwell in a non-specific way, even though respiratory function is maintained or improved. Patients should be encouraged to continue with Pulmicort therapy whilst withdrawing the oral steroid, unless there are clinical signs to indicate the contrary.
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 previously been dependent on oral steroids may, as a result of prolonged systemic steroid therapy, experience the effects of impaired adrenal function. Recovery may take a considerable amount of time after cessation of oral steroid therapy, hence oral steroid-dependent patients transferred to budesonide may remain at risk from impaired adrenal function for some considerable time.
In such circumstances, HPA axis functions should be monitored regularly. Acute exacerbations of asthma may need an increase in the dose of Pulmicort or additional treatment with a short course of oral corticosteroid and/or an antibiotic, if there is an infection.
The patient should be advised to use a short-acting inhaled bronchodilator as rescue medication to relieve acute asthma symptoms. Pulmicort 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. , higher doses of inhaled budesonide or the addition of a long-acting beta agonist, or for a course of oral glucocorticosteroid.
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. These patients should be instructed to carry a steroid warning card indicating their needs. Treatment with supplementary systemic steroids or Pulmicort should not be stopped abruptly.
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. Reduced liver function affects the elimination of corticosteroids causing lower elimination rate and higher systemic exposure.
Be aware of […]