Provexel Special Precautions

Excessive use of sympathomimetic oral inhalations has been associated with fatalities. The exact cause of death is unknown but cardiac arrest following severe, acute asthmatic crisis and hypoxia is suspected.
Asthma Exacerbations: Patients who are overdependent on rapid-acting inhaled beta-2-agonists, especially those who use more than one canister of salbutamol (or equivalent) monthly is at high risk of asthma-related death. They require closer supervision by the physician and should be encouraged to seek urgent care early in the course of their exacerbations.
Paradoxical Bronchospasm: Paradoxical bronchospasm, a potentially life-threatening event, has been observed with inhaled salbutamol. If it occurs, discontinue use of the product immediately.
Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronologically over several days or longer. Increased use of beta-2-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.
Hypokalemia: Therapy with salbutamol and other beta-2-agonists may produce a decrease in plasma potassium concentration possibly through intracellular shunting resulting in cardiovascular undesirable effects.
Use with caution in acute severe asthma where concomitant therapy with steroid, xanthine derivatives, or diuretics and by hypoxia may result in hypokalemia; potassium concentrations should be monitored in severe asthma.
Coexisting Conditions: Use with caution in patients with the following conditions: Cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, or hypertension. Salbutamol, like all other beta-2-agonists, can produce clinically significant cardiovascular effects such as changes in pulse rate or blood pressure.
Convulsive disorders.
Hyperthyroidism.
Diabetes mellitus.
In patients who are unusually responsive to sympathomimetic amines.
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.