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Hypersensitivity: Immediate hypersensitivity reactions may occur after administration of Ipratropium + Salbutamol , as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal oedema.
Paradoxical bronchospasm: 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 inhaled bronchodilator and should be treated straightaway. Ipratropium + Salbutamol should be discontinued immediately, the patient should be assessed and alternative therapy instituted if necessary.
Ocular complications: There have been rare cases of ocular complications (i.e. mydriasis, blurring of vision, narrow-angle glaucoma and eye pain) when the contents of metered aerosols containing ipratropium bromide have been sprayed inadvertently into the eye.
Patients must be instructed in the correct use of Ipratropium + Salbutamol and warned not to allow the solution or mist to enter the eyes. This is particularly important in patients who may be pre-disposed to glaucoma. Such patients should be warned specifically to protect their eyes. Eye pain or discomfort, blurred vision, visual halos or coloured images, in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Systemic effects: In the following conditions Ipratropium + Salbutamol should only be used after careful risk/benefit assessment: Insufficiently controlled diabetes mellitus, recent myocardial infarction and/or severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.
Cardiovascular effects: Cardiovascular effects may be seen with sympathomimetic drugs including Ipratropium + Salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol for respiratory disease, 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.
Hypokalaemia: Potentially serious hypokalaemia may result from beta2-agonist therapy. Particular caution is advised in severe airway obstruction as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics.
Additionally, hypoxia may aggravate the effects of hypokalaemia on cardiac rhythm (especially in patients receiving digoxin). It is recommended that serum potassium levels are monitored in such situations.
Gastro-intestinal motility disturbances: Patients with cystic fibrosis may be more prone to gastro-intestinal motility disturbances.
Dyspnoea: The patient should be instructed to consult a doctor immediately in the event of acute, rapidly worsening dyspnoea. In addition, the patient should be warned to seek medical advice should a reduced response become apparent.
Lactic acidosis: Lactic acidosis has been reported in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute exacerbation of bronchospasm in severe asthma or chronic obstructive pulmonary disease. 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 beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.
Interference with laboratory tests or other diagnostic measures: The use of Ipratropium + Salbutamol may lead to positive results with regards to salbutamol in tests for non clinical substance abuse, e.g. in the context of athletic performance enhancement (doping).
