0000024147 00000 n The nebuliser should be cleaned after each use. This dose is given as a single administration, or as two 1 mg doses separated by 30 minutes. Budesonide Nebuliser Suspension is then given, in combination with the previously used oral steroid dose, for about 10 days. In placebo-controlled studies, cataract was also uncommonly reported in the placebo group. 0000022383 00000 n /Length 244 The efficacy of budesonide nebuliser suspension has been evaluated in a large number of studies, and it has been shown that budesonide nebuliser suspension is effective both in adults and children as once- or twice-daily medication for prophylactic treatment of persistent asthma. A suitable fill volume for most nebulisers is 2 - 4 ml. atrovent xopenex diskus Raised plasma concentrations of and enhanced effects of corticosteroids have been observed in women also treated with oestrogens and contraceptive steroids, but no effect has been observed with budesonide and concomitant intake of low dose combination oral contraceptives. 0000022977 00000 n An air-flow rate of 6 - 8 litres per minute through the device should be employed. One ampoule of 2ml suspension contains 0.5mg budesonide. /E 27693 Animal studies have also identified an involvement of excess prenatal glucocorticosteroids, in increased risk for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range. 0000027212 00000 n There was also a 33% reduction in the length of stay. However, these animal experimental results do not appear to be relevant in humans at the recommended doses. Continue typing to refine. Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD. endobj 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), not known (cannot be estimated from the available data). This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist. Liver changes (primary hepatocellular neoplasms) found in male rats in the original carcinogenicity study were noted again in the repeat study with budesonide, as well as with the reference glucocorticosteroids. No unchanged budesonide has been detected in the urine. After the course of the oral drug, Budesonide Nebuliser Suspension alone should be sufficient therapy. See section 4.4 about titration to the lowest effective dose and about monitoring the growth 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. Per kg body weight children have a clearance which is approximately 50% greater than in adults. When suggestions are available use up and down arrows to review and ENTER to select. Clinical trials with 13,119 patients on inhaled budesonide and 7,278 patients on placebo have been pooled. << 0000011250 00000 n xref 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 such as rhinitis, eczema and muscle and joint pain. In a provocation study pre-treatment with budesonide for four weeks has shown decreased bronchial constriction in immediate as well as late asthmatic reactions. Treatment of persistent bronchial asthma in patients where use of a pressurised inhaler or dry powder formulation is unsatisfactory or inappropriate. Immediate and delayed hypersensitivity reactions* including rash, contact dermatitis, urticaria, angioedema and anaphylactic reaction. At 2 hours, both the budesonide nebuliser suspension and placebo groups showed a similar improvement in croup symptom score, with no statistically significant difference between the groups. To minimise the risk of oropharyngeal candida infection, the patient should rinse their mouth out with water after inhaling. 0000001892 00000 n 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. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. After first opening of the foil sachet, the ampoule may be stored unopened for three months. In 4-6 years old asthmatic children, the systemic availability of budesonide following administration of Budesonide Nebuliser Suspension via a jet nebuliser (Pari LC Jet Plus with Pari Master compressor) is approximately 6% of the nominal dose and 26% of the dose delivered to the patients. Budesonide 0.5 mg Nebuliser Suspension (0.25 mg/ml). Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The kinetics of budesonide are dose-proportional at clinically relevant doses. Budesonide nebuliser suspension may permit replacement or significant reduction in dosage of oral glucocorticosteroids while maintaining asthma control. Children 12 years and older: Dosage as for adults. However, in one study children who had been treated with high dose inhaled budesonide via a dry powder inhaler (400 micrograms daily) for up to 6 years without titration to the lowest effective dose were found on average to be 1.2 cm shorter as adults than those treated with placebo over the same period. The maximal plasma concentration, occurring approximately 20 min after start of nebulisation is approximately 2.4 nmol/L in 4-6 years old asthmatic children after a 1 mg dose. The contents of the ampoule should be gently squeezed into the nebuliser cup. This is about the same as in healthy adults. Facial irritation, as an example of a hypersensitivity reaction, has occurred in some cases when a nebuliser with a face mask has been used. /S 242 73 0 obj Any unused solution should be discarded, Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK. 0000017901 00000 n Results from subacute and chronic toxicity studies show that the systemic effects of budesonide are less severe than, or similar to, those observed after administration of other glucocorticosteroids, e.g. 0000018400 00000 n Treatment with inhaled budesonide has been used to effectively prevent exercise-induced asthma. 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). Patients received either budesonide 2 mg nebuliser suspension or placebo every 12 h for a maximum of 36 h or until discharge from hospital. Very serious pseudocroup (laryngitis subglottica) in which hospitalisation is indicated. After that, the oral steroid dose should be gradually reduced (by, for example, 2.5 mg prednisolone or the equivalent each month) to the lowest possible level. 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. Children 3 months to 12 years: 0.5 1 mg twice daily. To view the changes to a medicine you must sign up and log in. Ultrasound nebulisers are not suitable for nebulisation of Budesonide Nebuliser Suspension and therefore cannot be recommended. This infection may require treatment with appropriate antifungal therapy and in some patients discontinuation of treatment may be necessary (see also section 4.2). Wash the nebuliser container and mouthpiece or face-mask in accordance with the manufacturer's instructions. To find similar products you must sign up and log in. If patients find short-acting bronchodilator treatment ineffective, or they need more inhalations than usual, medical attention must be sought. Budesonide is excreted in breast milk. In adults the systemic availability of budesonide following administration of Budesonide Nebuliser Suspension via a jet nebuliser is approximately 15% of the nominal dose and 40% to 70% of the dose delivered to the patients. If this occurs, treatment with inhaled budesonide should be discontinued immediately, the patient assessed and, if necessary, alternative treatment instituted. 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. 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. This is 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. After a single dose of orally inhaled budesonide, delivered via dry powder inhaler, improvement of the lung function is achieved within a few hours. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. For further information on the withdrawal of corticosteroids, see section 4.4. The terminal half-life of budesonide after inhalation is approximately 2.3 hours in asthmatic children. A reduction in the dose of budesonide should also be considered (see section 4.5). /Pages 43 0 R Adults (including the elderly and children 12 years and older). Start typing to retrieve search suggestions. % 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. A minor fraction of the systemically available drug comes from swallowed drug. Co-treatment with CYP3A inhibitors, e.g. If Budesonide Nebuliser Suspension is co-administered with anti-fungals (such as itraconazole and ketoconazole), the period between treatments should be as long as possible. A therapeutic effect is usually reached within 10 days. The exact mechanism of action of glucocorticosteroids in the treatment of asthma is not fully understood. Available clinical experience shows that there are no indications that budesonide, or other glucocorticosteroids, induce brain gliomas or primary hepatocellular neoplasms in man. The metabolites of budesonide are excreted as such or in conjugated form mainly via the kidneys. Reporting suspected adverse reactions after authorisation of the medicinal product is important. >> The dosage of Budesonide Nebuliser Suspension should be adjusted to the need of the individual. The only harmful effect after a large amount of sprays during a short period is a suppression of the cortex function. To prevent irritation of the facial skin the face should be washed after using the nebuliser with a mask. The frequency of anxiety was 0.52% on inhaled budesonide and 0.63% on placebo; that of depression was 0.67% on inhaled budesonide and 1.15% on placebo. 0000001754 00000 n Therefore, the combination should be avoided unless the benefit outweighs this increased risk, in which case patients should be monitored for systemic corticosteroid side effects. /PageMode /UseNone Budesonide concentrations in infant plasma samples were all less than the limit of quantification. Date of first authorisation/renewal of the authorisation. The clinical relevance of this to treatment with Budesonide Nebuliser Suspension is unknown as no data exist for inhaled budesonide, but increases in plasma levels and hence an increased risk of systemic adverse effects could be expected. 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 cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. In animal studies, glucocorticosteroids have been shown to induce malformations (see section 5.3). /L 838811 When transferral from oral steroids to budesonide nebuliser suspension is started, the patient should be in a relatively stable phase. /T 837727 As with other inhalation therapies paradoxical bronchospasm may occur, manifested by an immediate increase in wheezing and shortness of breath after dosing. startxref In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary. However, at therapeutic doses of budesonide no effects on the suckling child are anticipated. For single use only. endobj Dosing can be repeated every 12 hours for a maximum of 36 hours or until clinical improvement. Inhaled glucocorticosteroids should be considered in preference to oral glucocorticosteroids because of the lower systemic effects at the doses required to achieve similar pulmonary responses. A high dose of budesonide nebuliser suspension is then given in combination with the previously used oral steroid dose for about 10 days.