Asmalin MDI Special Precautions

General: The management of asthma should follow a stepwise approach and patient response should be monitored clinically using lung function tests. Patients should be advised to seek medical consultation if either the usual relief with salbutamol is diminished or the usual duration of action is reduced. Patients should be warned not to increase the dose and frequency of administration.
Paradoxical Bronchospasm: Paradoxical bronchospasm, a potentially life-threatening event, has been observed with salbutamol. It should be noted that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new nebule or inhaler. If it occurs, patients should be advised to discontinue use of the product immediately and to seek medical advice for alternative therapy.
Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. Increased use of beta₂-agonists, especially daily use, is a sign of deterioration of asthma control and indicates the need to reassess treatment. Possible need for anti-inflammatory treatment (e.g., corticosteroids) should be considered. In patients who are at risk for deterioration of asthma, daily peak flow monitoring may be instituted.
Hypokalemia: Therapy with salbutamol and other beta₂-agonists may produce decrease in plasma potassium concentration possibly through intracellular shunting resulting in cardiovascular undesirable effects. Use with caution in patients with acute severe asthma where concomitant therapy with corticosteroids, xanthine derivatives, or diuretics, and by hypoxia may result in hypokalemia; potassium concentrations should be monitored in severe asthma (see Interactions).
Metabolic Effects: As with other beta₂-agonists, salbutamol can induce reversible metabolic changes (e.g., increased blood sugar levels). The diabetic patient may be unable to compensate for this; and thus, result in the development of ketoacidosis. Concomitant administration of corticosteroids may exaggerate this effect (see Interactions).
Coexisting Conditions: Use with caution in patients with the following conditions: Cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, or hypertension: Salbutamol, like all other beta₂-agonists, can produce clinically significant cardiovascular effects such as changes in pulse rate or blood pressure; Convulsive disorders; Hyperthyroidism and thyrotoxicosis; Diabetes mellitus; In patients who are unusually responsive to sympathomimetic amines.
Effects on Ability to Drive and Use Machines: Salbutamol has not been reported to influence the ability to drive or use machines.
Use in Children: The safety and efficacy of orally inhaled salbutamol aerosol with hydrofluoroalkane (HFA) propellant have not been established in children younger than 4 years old.
Use in the Elderly: Data on the use of salbutamol inhalation aerosol in patients 65 years and older are limited and are insufficient to determine whether the efficacy and safety are similar to those of younger patients. Because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in elderly patients, salbutamol should be used with caution, starting at the lower end of the usual dosing range.