The potential for acute toxic effects following overdose of PULMICORT RESPULES (budesonide inhalation suspension) 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 WARNINGS AND PRECAUTIONS, Hypercorticism and Adrenal Suppression].

In mice, the minimal lethal inhalation dose was 100 mg/kg (approximately 410 and 120 times, respectively, the maximum recommended daily inhalation dose in adults and children 12 months to 8 years of age on a mg/m² basis). In rats there were no deaths at an inhalation dose of 68 mg/kg (approximately 550 and 160 times, respectively, the maximum recommended daily inhalation dose in adults and children 12 months to 8 years of age on a mg/m² basis). In mice, the minimal oral lethal dose was 200 mg/kg (approximately 810 and 240 times, respectively, the maximum recommended daily inhalation dose in adults and children 12 months to 8 years of age on a mg/m² basis). In rats, the minimal oral lethal dose was less than 100 mg/kg (approximately 810 and 240 times, respectively, the maximum recommended daily inhalation dose in adults or and children 12 months to 8 years of age on a mg/m² basis).

The use of PULMICORT RESPULES (budesonide inhalation suspension) is contraindicated in the following conditions:

• 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 PULMICORT RESPULES [see WARNINGS AND PRECAUTIONS, DESCRIPTION and ADVERSE REACTIONS, Post-marketing Experience].

Last reviewed on RxList: 7/29/2010
This monograph has been modified to include the generic and brand name in many instances.