The recommended starting dose and highest recommended dose of budesonide inhalation suspension, based on prior asthma therapy, are listed in the following table.
Previous Therapy
Recommended Starting Dose
Highest Recommended Dose
Bronchodilators alone
0.5 mg total daily dose administered
twice daily in divided doses
0.5 mg total daily dose
Inhaled Corticosteroids
0.5 mg total daily dose administered
twice daily in divided doses
1 mg total daily dose
Oral Corticosteroids
1 mg total daily dose administered
as 0.5 mg twice daily
1 mg total daily dose
2.1 Dosing Recommendations
Dosing recommendations based on previous therapy are as follows:
Bronchodilators alone: 0.25 mg twice daily
Inhaled corticosteroids: 0.25 mg twice daily up to 0.5 mg twice daily
Oral corticosteroids: 0.5 mg twice daily
In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved.
2.2 Directions for Use
Budesonide inhalation suspension should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of budesonide inhalation suspension and, therefore, are NOT recommended.
The effects of mixing budesonide inhalation suspension with other nebulizable medications have not been adequately assessed. Budesonide inhalation suspension should be administered separately in the nebulizer [see Patient Counseling Information, Administration with a jet nebulizer (17.1)].
A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver budesonide inhalation suspension to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of budesonide inhalation suspension delivered by other nebulizers and compressors have not been established.