Budesonide is an overview of a product.

In some cases, the use of a dry powder or pressurised inhaler is inappropriate for the treatment of persistent bronchial asthma.

Depending on the equipment used, the dose delivered to the patient varies.The nebulisation time and dose is dependent on a number of factors.An air-flow rate of 6 - 8 litres per minute should be used.The fill volume for most nebulisers is 2 - 4 liters.Budesonide Nebuliser Suspension should be adjusted to the needs of the individual.To maintain good asthma control, the dose should be reduced.Only children with severe asthma and during limited periods should be considered for the highest dose.

During periods of severe asthma, the recommended dose of Budesonide Nebuliser Suspension is:

The lowest dose is what keeps the patient symptom-free.

Budesonide nebuliser suspension can allow replacement of oral glucocorticosteroids while maintaining asthma control.The patient should be in a relatively stable phase when transferral from oral steroids to budesonide nebuliser suspension is started.The previously used oral steroid dose is combined with a high dose of budesonide nebuliser suspension for about 10 days.

The oral steroid dose should be gradually reduced to the lowest possible level after that.It is possible to substitute the oral steroid with budesonide nebuliser suspension.Section 4.4 contains further information on the withdrawal of corticosteroids.

Budesonide Nebuliser Suspension can be used with solutions for nebulisation of terbutaline.It should be used within 30 minutes.

An increased dose of Budesonide Nebuliser Suspension is recommended, rather than combined treatment with oral corticosteroids, because of the lower risk of systemic effects, where an increased therapeutic effect is desired.

The usual dose of budesonide in infants and children is 2.This dose can be given as a single administration or as two separate doses.For a maximum of 36 hours, dosing can be repeated every 12 hours.

Shake it gently and open it by twisting off the wing tab.The contents should be squeezed into the cup.The top of the nebuliser cup should be replaced.

Budesonide Nebuliser Suspension must be administered with a jet nebuliser.The nebuliser should be connected to an air compressor that has adequate air flow.

There can be differences in performance between nebulizers even if they are the same make and model.

The instructions for use in the patient information leaflet are packed with the nebulisers.

Budesonide Nebuliser Suspension can't be nebulised with the help of a seismologist.

After inhaling, the patient should rinse their mouth out with water.

The face should be washed after using a mask.

After each use, the nebuliser should be cleaned.The nebuliser container should be washed in accordance with the manufacturer's instructions.

Special caution is needed in patients with active or quiescent pulmonary Tuberculosis.

Within 10 days, a therapeutic effect can be reached.An additional oral corticosteroid regimen can be given to patients with excessive mucus in the bronchi.Budesonide Nebuliser Suspension should be enough therapy after the course of the oral drug.

When Budesonide Nebuliser Suspension is used, the patient should be in a relatively stable phase.For about 10 days, Budesonide Nebuliser Suspension is given in combination with the previously used oral steroid dose.The oral steroid dose should be gradually reduced to the lowest possible level after that.It is possible to substitute Budesonide Nebuliser Suspension for the oral corticosteroid.

During transfer from oral therapy to Budesonide Nebuliser Suspension, a generally lower systemic corticosteroid action will be experienced, which may result in the appearance of allergic or arthritic symptoms.Treatments should be initiated for these conditions.

In rare cases, symptoms such as tiredness, headaches, nausea and vomiting should be suspected if there is a general insufficient glucocorticosteroid effect.Sometimes an increase in the dose of oral glucocorticosteroids is necessary.

It is possible for bronchospasm to occur as a result of an immediate increase in wheezing and shortness of breath after a dose.If this happens, treatment with budesonide should be stopped immediately and the patient assessed.

Patients who have required high dose emergency corticosteroid therapy may be at risk of impaired adrenal function.The signs and symptoms of adrenal insufficiency can be seen in these patients.During periods of stress or surgery, additional systemic corticosteroid treatment should be considered.

Systemic effects can occur with high doses of inhaled corticosteroid.The effects are less likely to occur with inhalation treatment.

There are a number of possible systemic effects, including growth retardation in children and adolescents, a decrease in bone mineral density, and a range of psychological or behavioural effects.Effective control of asthma can only be maintained at the lowest dose of inhaled corticosteroid.

Budesonide Nebuliser Suspension is not intended for rapid relief of acute episodes of asthma where a bronchodilator is required.If short-acting bronchodilator treatment is not effective or they need more inhalations than usual, medical attention must be sought.In this situation, consideration should be given to the need for a higher dose of inhaled budesonide or a course of oral glucocorticosteroid.

In patients with severe hepatic impairment, treatment with budesonide can result in a reduced elimination rate.HPA axis function in these patients should be monitored at regular intervals because of possible systemic effects.

In cirrhotic patients and in healthy subjects, the clearance of the plasma following a dose of budesonide was the same.The availability of budesonide was increased after oral ingestion.The clinical relevance of this to treatment with Budesonide Nebuliser Suspension is unknown as no data exist for it, but an increased risk of systemic adverse effects could be expected.

Co-treatment with a drug.The risk of systemic corticosteroid side effects is expected to increase with the use of itraconazole.If the benefit outweighs the increased risk, the combination should be avoided.This is of limited clinical importance for short-term treatment with itraconazole or other potent CYP3A inhibitors, but should be considered during long- term treatment.The dose of budesonide should be reduced.

After every administration, the nebuliser chamber should be cleaned.Use a mild detergent to wash the nebuliser chamber and face mask.You can rinse well and dry by connecting the nebuliser chamber to the compressor or air inlet.

The therapy may cause oral candidiasis.This infection may require treatment with appropriate antifungal therapy and in some patients it may be necessary to stop treatment.

There has been an increase in the incidence of pneumonia in patients with COPD.There is some evidence of an increased risk of pneumonia, but this has not been proven in all studies.

There is no evidence to support the idea of class differences in the risk of pneumonia.

The symptoms of COPD exacerbations overlap with the clinical features of pneumonia infections in patients with COPD.

Current smoking, older age, low body mass index and severe COPD are risk factors for pneumonia in patients with COPD.

It is possible to report visual disturbance with systemic and topical corticosteroid use.If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataracts, glaucoma or rare diseases like central serous chorioretinopathy (CSCR) which have been reported after use

It is recommended that the height of children receiving treatment is monitored.If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained.The risks of growth suppression and the benefits of the therapy need to be considered.The patient should be referred to a respiratory specialist.

Budesonide Nebuliser Suspension should be used.The use of an Ultrasonic nebuliser is not appropriate.

The metabolism of budesonide is mostly done by the CYP3A4.Co-treatment with a drug.The risk of systemic side effects is expected to increase with the use of itraconazole.If the benefit outweighs the increased risk of systemic corticosteroid side effects, Budesonide Nebuliser Suspension should be avoided.The period between treatments should be as long as possible if Budesonide Nebuliser Suspension is co-administered with anti-fungals.The budesonide dose could be reduced.There is limited data about the interaction between high-dose budesonide and itraconazole, which may lead to marked increases in plasma levels.

In women who are also treated with oestrogens and contraceptive steroids, raised concentrations of and enhanced effects of corticosteroids have been observed, but no effect has been seen with budesonide and concurrent intake of low dose oral contraceptives.

A stimulation test for pituitary insufficiency might show false results because of suppressed adrenal function.

Most results from prospective epidemiological studies and world-wide post-marketing data have not been able to detect an increased risk for adverse effects for the fetus and newborn child.In animal studies, glucocorticosteroids have been shown to cause malformations.It's not likely to be relevant for humans given recommended doses, but therapy with inhaled budesonide should be regularly reviewed and maintained at the lowest effective dose.

Asthma treatment is important for both the mother and the fetus.The benefit of budesonide for the mother should be weighed against the risks to the fetus.The lower systemic effects of oral glucocorticosteroids make them a better choice for asthma sufferers.

Budesonide can be found in breast milk.No effects on the suckling child are anticipated at therapeutic doses of budesonide.Budesonide can be used during breast feeding.

Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in asthmatic nursing women results in negligible systemic exposure to budeonide in breast-fed infants.

In a study, the estimated daily infant dose was less than the daily maternal dose, and the average concentration in infants was 1/600th of the maternal concentration.Budesonide concentrations were less than the limit of quantification.

The suckling child is likely to be low exposed due to the fact that budesonide exhibits linear PK properties within the therapeutic dosage intervals after nasal, inhaled, oral and rectal administrations.

The incidence of undesirable effects are defined by the following definitions.

rash, contact dermatitis, urticaria, angioedema and anaphylactic reaction are immediate and delayed hypersensitivity reactions.

There are signs and symptoms of systemic corticosteroid effects.

Psychomotor and sleep disorders are more common in children.

Occasionally, signs or symptoms of systemic glucocorticosteroid-side effects may occur, depending on dose, exposure time, previous corticosteroid exposure, and individual sensitivity.

Drug deposition is the cause of the candida infections in the oropharynx.The patient should rinse their mouth with water after each dose.

In rare cases, bronchospasm may occur.

An example of a hypersensitivity reaction is facial irritation when a nebuliser with a face mask is used.After using the face mask, the facial skin should be washed with water.

There are 13,189 patients on inhaled budesonide and 7,279 on placebo.Inhaled budesonide had a lower incidence of anxiety and depression than placebo.

Growth should be monitored due to the risk of growth retardation in children.

It is important to report suspected adverse reactions after the product is approved.The benefit/risk balance of the product can be monitored.If you want to report a suspected adverse reaction, you can either use the Yellow Card scheme or the MHRA app.

Acute overdose with budesonide is not usually a problem.suppression of the cortex function is the only harmful effect after a large amount of sprays.

A degree of cortex atrophy in addition to adrenocortical suppression may occur if it is a matter of chronic use of very high doses.

There is no need for emergency measures.The adrenocortical function will repair itself within 1-2 days if the treatment is continued with the lowest effective maintenance dose.

The patient should be treated as a steroid dependent and transferred to a maintenance dose with a systemic steroid.When the condition is stable, the patient should continue the treatment with budesonide.

Budesonide has a lower incidence and severity of adverse effects than oral corticosteroids.

glucocorticosteroids are used in the treatment of asthma.Anti-Inflammatory actions such as inhibition of the release of inflammatory mediator release are important.

There was statistically significant evidence of efficacy with inhaled but not oral budesonide compared with placebo in a clinical study of asthmatics.The therapeutic effect of conventional doses of budesonide may be explained by its action on the respiratory tract.

Pre-treatment with budesonide for four weeks has shown a decrease in bronchial constriction.

Within a few hours, the lung function can be improved after a single dose of budesonide.After therapeutic use of oral budesonide delivered via dry powder inhaler, improvement in lung function has been shown to occur within 2 days of initiation of treatment, although maximum benefit may not be achieved for up to 4 weeks.

It was shown that budesonide reduces the reactivity of the airway in hyperreactive patients.

Within the first year of treatment, a small reduction in growth has been observed in short term studies.According to long-term observational studies, children and adolescents who are treated with inhaled corticosteroids achieve their adult target height.In one study children who had been treated with high dose budesonide via a dry powder inhaler for up to 6 years without titration to the lowest effective dose were found to be 1.2 cm shorter as adults than the placebo group.The section deals with titration to the lowest effective dose and monitoring the growth of children.

Studies in healthy volunteers with budesonide have shown dose related effects.The ACTH test shows that inhaled budesonide causes less effect on adrenal function than the steroid prednisone.

Budesonide nebuliser suspension has been shown to be effective for prophylactic treatment of persistent asthma in both children and adults.Below are some examples of representative studies.

There are a number of studies comparing budesonide nebuliser suspension with placebo.Representative studies evaluating the use of budesonide for the treatment of children with croup can be found below.

A randomized, double-blind placebo-controlled trial was conducted in 87 children who were admitted to the hospital with a clinical diagnosis of croup.The budesonide nebuliser suspension was given after an initial dose of 2 or placebo.In patients with an initial croup symptom score above 3, budesonide nebuliser suspension significantly improved their score at 12 and 24 hours.The length of stay was reduced by a third.

A randomized, double-blind, placebo-controlled study compared the efficacy of budesonide nebuliser suspension and placebo in the treatment of croup in 83 infants and children who were admitted to the hospital.Patients were given either placebo or budesonide for a maximum of 36 hours until they were discharged from the hospital.After the initial dose, the total croup symptom score was assessed.The budesonide nebuliser suspension and placebo groups showed the same improvement in the croup symptom score at 2 hours.By 6 hours, the croup symptom score in the budesonide nebuliser suspension group was significantly improved compared with the placebo group, and this improvement was also visible at 12 and 24 hours.

Budesonide Nebuliser Suspension via a jet nebuliser is used for 15% to 30% of the nominal dose in adults.A small amount of the drug comes from swallowed drugs.After a single dose of 2 grams, the maximal plasma concentration is approximately 4 nmol/L.

Budesonide has a volume of distribution.The average is 85 - 90%.

Budesonide undergoes an extensive degree of biotransformation on its way through the body.The glucocorticosteroid activity is less than that of budesonide.The metabolism of budesonide is mainly done by the sub family of cytochrome P450.

The urine from budesonide is usually in the form of aconjugated form.Budesonide has not been found in the urine.Budesonide has high systemic clearance in healthy adults, and it has a terminal half-life of about 3 hours.

By 7.8-fold, the increased levels of oral budesonide in the study were due to the fact that 100MG of ketoconazole was taken twice daily.There is no information about this interaction for budesonide.

Budesonide has a clearance of less than 1 L/min in asthmatic children.Children have a clearance that is 50% greater than adults.The half-life of budesonide in asthmatic children is 2.3 hours.This is the same as in healthy adults.Budesonide Nebuliser Suspension can be administered via a jet nebuliser and delivered to patients at a rate of 26% of the nominal dose.The availability in children is less than in healthy adults.After a single dose of nebulisation, the maximal plasma concentration is approximately 2.4 nmol/L in 3-6 year old asthmatic children.The exposure of budesonide to children is comparable to that of healthy adults given the same delivered dose by the nebuliser system.

The acute toxicity of budesonide is comparable to that of the reference glucocorticosteroids studied.

The systemic effects of budesonide are less severe than those observed after administration of other glucocorticosteroids, according to the results of subacute and chronic toxicity studies.Decreased body-weight gain and atrophy of the adrenal cortex.

The incidence of brain gliomas in male rats could not be verified in a repeat study in which the groups on active treatment did not differ.

In the repeat study with budesonide, as well as with the reference glucocorticosteroids, the primary hepatocellular neoplasms found in male rats in the original carcinogenicity study were noted again.These effects are related to a class effect.

There are no indications that budesonide or other glucocorticosteroids cause brain gliomas in man.

Corticosteroids have been shown to induce malformations in animal reproduction studies.The animal results don't seem to be relevant to humans at the recommended doses.

Fetal glucocorticosteroids have been found to be involved in increased risk for growth retardation, adult cardiovascular disease and permanent changes in neurotransmitters.

The product must not be mixed with other products.

Pack sizes include 5, 20, 24, 40, 2 x 20 and 60 Ampoules.

Budesonide nebuliser suspension can be mixed with a variety of drugs.