The potential for acute toxic effects following overdose of PULMICORT RESPULES is low. If inhaled corticosteroids are used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism or growth suppression may occur (see PRECAUTIONS).

In mice the minimal lethal inhalation dose was 100 mg/kg (approximately 410 or 120 times, respectively, the maximum recommended daily inhalation dose in adults or children on a mg/m² basis). In rats there were no deaths at an inhalation dose of 68 mg/kg (approximately 550 or 160 times, respectively, the maximum recommended daily inhalation dose in adults or children on a mg/m² basis). In mice the minimal oral lethal dose was 200 mg/kg (approximately 810 or 240 times, respectively, the maximum recommended daily inhalation dose in adults or children on a mg/m² basis). In rats, the minimal oral lethal dose was less than 100 mg/kg (approximately 810 or 240 times, respectively, the maximum recommended daily inhalation dose in adults or children on a mg/m² basis).

PULMICORT RESPULES is contraindicated as the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Hypersensitivity to budesonide or any of the ingredients of this preparation contraindicates the use of PULMICORT RESPULES.

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