Budesonidedosage

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 Recommended dosing based on previous therapy . Start with the lowest recommended dose:

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

Once asthma stability is achieved, titrate the dose downwards.

For inhalation use via compressed air driven jet nebulizers only (not for use with ultrasonic devices). Not for injection.

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. 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.