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SALBUTAMOL NORIDEM is a brand name for Albuterol (also known as Salbutamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Brodilaten/Salbutamol Noridem is indicated in adults, adolescents and children aged 4 to 11 years. Brodilaten/Salbutamol Noridem 2.5 mg / 2.5 mL Nebuliser solution is not indicated for babies and children under 4 years of age, see section
Verbatim from this product's MHRA label. Tap a section to expand.
2. Brodilaten/Salbutamol Noridem is indicated for treatment of severe acute exacerbations of chronic obstructive pulmonary disease (COPD), and in the treatment of acute severe asthma. 5 mg to 5 mg salbutamol up to four times a day. Up to 40 mg per day can be given under strict medical supervision in hospital.
Paediatric Population Children aged 12 years and over:
Dose as per adult population. 5 mg to 5 mg up to four times a day. The clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.
Brodilaten/Salbutamol Noridem is intended to be used undiluted. However, if prolonged delivery time (more than 10 minutes) is required, the solution may be diluted with sterile normal saline to a 1:1 dilution. Method of administration Brodilaten/Salbutamol Noridem is for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable nebuliser.
The solution should not be injected or swallowed. For single use only. Use immediately after first opening the single-dose container. Any solution remaining in the nebuliser after nebulisation should be discarded. g. PARI LC SPRINT nebuliser, after the single dose ampoule has been opened and its contents transferred to the nebuliser chamber.
For full instructions on the use of the nebuliser the patient should be instructed to read the leaflet of the respective device carefully before starting the inhalation. 0 bar The delivered dose of Brodilaten/Salbutamol Noridem may vary depending on the nebuliser system used.
Τhe use of an alternative nebuliser system(s) may alter the pulmonary deposition of the active substance, this in turn may alter the efficacy and safety of the product and dose adjustment may then become necessary. The nebulised solution may be inhaled through a face mask, T-piece or via an endotracheal tube.
Intermittent positive pressure ventilation (IPPV) may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air. As many nebulisers operate on a continuous flow basis, it is likely that some nebulised drug will be released into the local environment.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000). Very common and common events were generally determined from clinical trial data.
Rare, very rare and unknown events were generally determined from spontaneous data. System Organ Class Frequency Adverse Drug Reaction Immune system disorders Very rare Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse Rare Hypokalaemia.
4) Vascular disorders Rare Peripheral vasodilatation Respiratory, thoracic and mediastinal disorders Very rare Paradoxical bronchospasm Gastrointestinal disorders Uncommon Mouth and throat irritation Musculoskeletal and connective tissue disorders Uncommon Muscle spasm * reported spontaneously in post-marketing data therefore frequency regarded as unknown.
As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting bronchodilator and therefore should be treated with an alternative presentation or a different rapid-acting inhaled bronchodilator and should be treated straightaway.
Brodilaten/Salbutamol Noridem should be discontinued immediately, the patient assessed and alternative therapy instituted, if necessary. For on-going use a different rapid-acting may be required. Paediatric population In addition, very rare adverse events of psychiatric / behavioral disorders regarding nervousness and agitation, as well as pruritus have been reported in paediatric population.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Brodilaten/Salbutamol Noridem must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed. Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma.
Severe asthma requires regular medical assessment, including lung- function testing, as patients are at risk of severe attacks and even death. Physicians should consider using the maximum recommended dose of inhaled corticosteroid and/or oral corticosteroid therapy in these patients.
Patients receiving treatment at home should seek medical advice if treatment with Brodilaten/Salbutamol Noridem becomes less effective. The dosage or frequency of administration should only be increased on medical advice. Patients being treated with Brodilaten/Salbutamol Noridem may also be receiving other dosage forms of short-acting inhaled bronchodilators to relieve symptoms.
, inhaled corticosteroids) should be advised to continue taking their anti-inflammatory medication even when symptoms decrease, and they do not require Brodilaten/Salbutamol Noridem. Increasing use of bronchodilators, in particular short-acting inhaled β2 agonists to relieve symptoms, indicates deterioration of asthma control, and patients should be warned to seek medical advice as soon as possible.
The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective or more inhalations than usual are required. g. higher doses of inhaled corticosteroid or a course of oral corticosteroid).
Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality. , daytime symptoms, night-time awakening, and activity limitation due to asthma) for proper treatment adjustment as these patients are at risk for overuse of salbutamol.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brodilaten/Salbutamol Noridem should therefore be administered in a well-ventilated room, particularly in hospitals when several patients may be using nebulisers at the same time.
Dilution:
Brodilaten/Salbutamol Noridem may be diluted with sterile normal saline. Solutions in nebulisers should be replaced daily.
Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis. Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol.
g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
Sportsmen should be warned that this drug contains an active substance, which may induce a positive result in anti-doping controls. Brodilaten/Salbutamol Noridem should be used with care in patients known to have received large doses of other sympathomimetic drugs.
Potentially serious hypokalaemia may result from β2 agonist therapy, mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics.
Serum potassium levels should be monitored in such situations. In common with other β adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported.
Concurrent administration of corticosteroids can exaggerate this effect. 9). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting β agonist treatment.
It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting. A small number of cases of acute angle-closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol and ipratropium bromide.
A combination of nebulised salbutamol with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.
As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting bronchodilator and therefore should be treated with an alternative presentation or a different rapid acting inhaled bronchodilator and should be treated straightaway.
Brodilaten/Salbutamol Noridem should be discontinued immediately, the patient assessed and alternative therapy instituted, if necessary. For on-going use a different rapid-acting may be required.