Salbutamol sulfate is a white or almost white powder. It is soluble in water but is only slightly soluble in alcohol, chloroform and ether. 1.2mg of salbutamol sulfate is equivalent to 1.0mg of salbutamol base.
APO-Salbutamol Inhaler contains microcrystalline salbutamol sulfate suspended in norflurane (1,1,1,2- tetrafluoroethane), a CFC-free propellant which does not deplete ozone from the atmosphere. Each metered dose delivers an amount of salbutamol sulfate equivalent to 100 ?g of salbutamol. APOSalbutamol Inhaler also contains oleic acid and ethanol. APO-Salbutamol Inhaler is available in pack sizes containing 200 doses.
Relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise-induced asthma or in other situations known to induce bronchospasm.
Known hypersensitivity to salbutamol sulfate or other sympathomimetics, or to any other ingredients.
Use with caution in the following circumstances:
Cardiac disease: When APO-Salbutamol Inhaler is used at the recommended doses the blood concentrations of salbutamol are usually too low to produce a significant systemic effect. However, prescribers should be aware of the possibility of the unwanted stimulation of cardiac adrenergic receptors and care should be taken in patients with hypertension, coronary artery disease and myocardial insufficiency.
Cardiac arrhythmias: Salbutamol may predispose to the occurrence of cardiac arrhythmias or may exacerbate existing arrhythmias. This effect may be due to a direct chronotropic effect and to the reduction of serum potassium. Care should be taken when using salbutamol in patients who have arrhythmias or who are receiving drugs such as digitalis or diuretics which do not spare potassium. Caution should also be taken when using salbutamol with anaesthetic agents which sensitise the myocardium to sympathomimetic agents.
Hypokalaemia: Potentially serious hypokalaemia may result from 2-agonist therapy mainly from parenteral and nebulised administration. This effect may be potentiated in patients with hypoxia or those treated concomitantly with theophylline, steroids or diuretics. Caution should be taken in these patients.
Diabetes mellitus: When given by inhalation at recommended doses salbutamol should have little or no hyperglycaemic effect; however care should be taken initially in using salbutamol in diabetics.
Hyperthyroidism: Salbutamol should be used with caution in patients with thyrotoxicosis.
There are no reasons to consider norflurane as a potential mutagen, clastogen or carcinogen judging from in-vitro and in-vivo studies which include long-term administration by inhalation in rodents.
Use in Pregnancy
There is no experience of APO-Salbutamol Inhaler in pregnant women. An inhalation reproductive study with APO-Salbutamol Inhaler in rats did not exhibit any teratogenic effects. Salbutamol does however cross the placenta. In some rodent studies large doses of salbutamol have been shown to be teratogenic although the relevance of these findings to humans is unknown. Safe use in pregnancy has not been established; therefore APO-Salbutamol Inhaler should not be used during pregnancy unless the benefits outweigh the potential risk.
Use in Lactation
There is no experience of APO-Salbutamol Inhaler in lactating women. It is unknown whether salbutamol is excreted in breast milk. APO-Salbutamol Inhaler should therefore not be used in women who are breast-feeding unless the benefits of therapy outweigh the potential risk to the infant.
Interactions with Other Medicines
Beta-adrenergic blockers specifically antagonise the action of salbutamol and other sympathomimetics on the airways. Use of these drugs is also generally contraindicated in asthma because they tend to increase airway resistance. Concomitant use of theophylline (and other xanthine derivatives), steroids and diuretics may potentiate salbutamol-induced hypokalaemia in acute severe asthma. In those circumstances and in other situations (such as hypoxia) likely to potentiate salbutamol-induced hypokalaemia, serum potassium levels should be monitored.
APO-Salbutamol Inhaler is therapeutically equivalent to CFC salbutamol pressurised inhalers. Patients can be switched from CFC salbutamol pressurised inhalers to APO-Salbutamol Inhaler at the same dose without loss of therapeutic effect.
Adults: 1 to 2 inhalations every four hours as necessary to obtain relief of bronchospasm. If previously effective doses do not provide relief, other treatment should be instituted promptly.
Children: As for adults.
Elderly: Dosage should at first be lower than for younger adults but may be increased gradually to the usual adult level if necessary.
The symptoms of overdose are the same as the adverse effects of salbutamol, the most significant being tachycardia and/or muscle tremor. With the metered dose inhalers some toxicity may be due to the aerosol propellant.
Monitor biochemical abnormalities particularly hypokalaemia. Hypokalaemia should be treated with potassium replacement if necessary.
Presentation And Storage Conditions
APO-Salbutamol Inhaler: Each unit delivers salbutamol sulfate equivalent to salbutamol 100 ?g per metered dose. APO-Salbutamol Inhaler 200 dose delivers 200 doses. Each unit is supplied with an actuator.
APO-Salbutamol Inhaler should be stored below 30°C, away from direct heat or sunlight. As the canister is pressurised, no attempt should be made to puncture it or dispose of it by burning.
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