IPRATROPIUM BROMIDE AND SALBUTAMOL SULPHATE INHALATION is a brand name for Albuterol (also known as Salbutamol), supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution is contraindicated in: Patients with a history of hypersensitivity to any of its components or to atropine or its derivatives. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
Patients with cardiac tachyarrhythmias and hypertrophic obstructive cardiomyopathy. WARNINGS AND PRECAUTIONS General The unit dose ampoules are intended only for inhalation with suitable nebulizing devices and must not be taken orally or administered parenterally.
It is recommended that the nebulised Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution be administered via a mouth piece. If this is not available and a nebuliser mask is used, it must fit properly. Systemic Effects In the following conditions Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution should only be used after careful risk/benefit assessment: uncontrolled diabetes mellitus, recent myocardial infarction and/or severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy, urinary retention.
Care should be taken with patients suffering from coronary insufficiency, arrhythmias and hypertension, convulsive disorders and in patients who are unusually responsive to sympathomimetic amines. Fatalities have been reported following excessive use of inhaled sympathomimetic amines, the exact cause of which is unknown.
Excessive Use and Use with other Sympaticomimetics or Muscarinic Antagonists As with other inhaled bronchodilators, Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution should not be used more often or at higher doses than recommended.
Concomitant use of Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution with other sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects. Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution should not be administered concomitantly with other medicines containing a muscarinic antagonist, as this has not been studied, and an overdose may result (see DRUG INTERACTIONS).
Anticholinergic Effects Like other anticholinergic drugs, Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution should be used with caution in patients with narrow-angle glaucoma or urinary retention. Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution Page 5 of 40 Worsening of Narrow-Angle Glaucoma: Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution should be used with caution in patients with narrow-angle glaucoma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Care should be taken to ensure that the nebulizer mask fits the patient's face properly and that nebulized solution has not come in contact with the eyes. Patients should be advised that this may result in precipitation or worsening of narrow-angle glaucoma.
, use of swimming goggles or use of a nebulizer with a mouthpiece) are taken to ensure that nebulized solution does not reach the eye. , eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema).
Instruct patients to consult a physician immediately should any of these signs or symptoms develop. Miotic drops alone are not considered to be effective treatment.
Worsening of Urinary Retention:
Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution should be used with caution in patients with urinary retention. , difficulty passing urine, painful urination). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
Carcinogenesis and Mutagenesis Animal data only (see TOXICOLOGY Section). Cardiovascular Special care and supervision are required in patients with idiopathic hypertrophic subvalvular aortic stenosis, in whom an increase in the pressure gradient between the left ventricle and the aorta may occur, causing increased strain on the left ventricle.
Cardiovascular effects in some patients, as measured by pulse rate, blood pressure, and/or symptoms may be seen with sympathomimetic drugs, including Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol, one of the components of Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution.
In addition, beta-adrenergic agents like salbutamol, have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. Therefore, Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution should be used with caution in patients with cardiovascular disorders; especially coronary insufficiency, cardiac arrhythmias, and Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution Page 6 of 40 hypertension.
g. ischaemic heart disease, tachyarrhythmia or severe heart failure) who are receiving Ipratropium Bromide and Salbutamol Sulphate Inhalation Solution for respiratory disease should be warned to seek immediate medical advice if they experience chest pain or other symptoms of worsening heart disease.
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