Pulmodual/Pulmodual MDI Warnings

Pulmodual MDI: Salbutamol Sulphate and Ipratropium Bromide Inhalation can produce paradoxical bronchospasm that can be life-threatening. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister. The Salbutamol Sulphate contained in Salbutamol Sulphate and Ipratropium Bromide Inhalation, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure and/or symptoms. If these symptoms occur, discontinuation of the drug may be indicated. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischemia associated with salbutamol. In addition, beta-adrenergic agents 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, Salbutamol Sulphate and Ipratropium Bromide Inhalation should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
Immediate hypersensitivity reactions may occur after administration of ipratropium bromide or salbutamol sulphate, as demonstrated by urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. If such a reaction occurs, therapy with Salbutamol Sulphate and Ipratropium Bromide Inhalation should be stopped at once and alternative treatment should be considered.
Salbutamol Sulphate and Ipratropium Bromide Inhalation contains ipratropium bromide and, therefore, should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction.
Preparations containing sympathomimetic amines such as Salbutamol Sulphate should be used with caution in patients with convulsive disorders. Hyperthyroidism, or diabetes mellitus and in patients who are usually responsive to sympathomimetic amines. Beta-adrenergic agents may also produce significant hypokalemia in some patients (possibly through intracellular shunting) which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.
Salbutamol Sulphate and Ipratropium Bromide Inhalation has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.