Windel® Plus: Each ampoule contains 2.5 ml isotonic, clear solution for inhalation of salbutamol sulphate BP equivalent to Salbutamol 2.5 mg and Ipratropium Bromide BP equivalent to Ipratropium 0.5 mg.
Adults (including elderly): One ampoule as required for the relief of symptoms or as directed. Up to three to four ampoules daily.
Patients should be advised to consult a doctor or the nearest hospital immediately in the case of acute or rapidly worsening dyspnoea if additional inhalations do not produce an adequate improvement.
Potentially serious hypokalaemia may result from prolonged and / or high dose beta2-agonist therapy.
As with use of other inhalation therapy, cough, local irritation and, less commonly, inhalation induced bronchospasm can occur.
As with other beta-mimetics, nausea, vomiting, sweating, weakness and myalgia/muscle cramps may occur. In rare cases decrease in diastolic blood pressure, increase in systolic blood pressure, arrhythmias, particularly after higher doses, may occur.
In individual cases psychological alterations have been reported under inhalation therapy with beta-mimetics.
The most frequent non-respiratory anticholinergic related adverse events are dryness of mouth and dysphonia.
There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular pressure, angle-closure glaucoma, and eye pain) when aerosolised ipratropium bromide either alone or in combination with adrenergic beta2-agonist, has escaped into the eyes. Ocular side effects, gastrointestinal motility disturbances and urinary retention may occur in rare cases and are reversible.
Windel Plus should be used with caution before childbirth in view of Salbutamol's inhibitory effects on uterine contractions.
Salbutamol Sulphate and Ipratropium Bromide are probably excreted in breast milk and their effects on neonates are not known. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that this will happen to any extent especially when taken by inhalation. However, because many drugs are excreted in breast milk, caution should be exercised when Windel Plus is administered to a nursing woman.
Beta-agonist induced hypokalaemia may be increased by concomitant treatment with xanthine derivatives, glucocorticosteroids and diuretics. This should be taken into account particularly in patients with severe airway obstruction.
Hypokalaemia may result in an increased susceptibility to arrhythmias in patients receiving digoxin. It is recommended that serum potassium levels be monitored in such situations.
A potentially serious reduction in bronchodilator effect may occur during concurrent administration of beta-blockers.
Beta-adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta-adrenergic agonists may be enhanced.
Inhalation of halogenated hydrocarbon anaesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility to the cardiovascular effects of beta-agonists.
Manifestations of overdosage with Salbutamol may include tachycardia, anginal pain, hypertension, hypotension , palpitations, tremor, widening of the pulse pressure, arrhythmia and flushing.
Administration of sedatives, tranquillisers.
In severe cases, intensive therapy.
Beta-receptor blockers, preferably beta1-selective, are suitable as specific antidotes; however, a possible increase in bronchial obstruction must be taken into account and the dose should be adjusted carefully in patients suffering from bronchial asthma.