Budesonide Suspension label

Budesonide Suspension

Budesonide Suspension Recall

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Uses

1.1 Maintenance Treatment of Asthma

Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.

Important Limitations of Use:

• Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.

History

There is currently no drug history available for this drug.

Other Information

Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide inhalation suspension is provided as a mixture of two epimers (22R and 22S). The molecular formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is:

Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103.

Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients: citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride, sodium citrate dihydrate and water for injection. Three dose strengths are available in single-dose ampules: 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see DOSAGE AND ADMINISTRATION (2)].

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Budesonide Suspension Manufacturers

Sandoz Inc
No Recall
Budesonide Suspension | Sandoz Inc
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 either once daily or twice daily in divided doses

0.5 mg total daily dose

Inhaled Corticosteroids

0.5 mg total daily dose administered either once daily or twice daily in divided doses

1 mg total daily dose

Oral Corticosteroids

1 mg total daily dose administered either as 0.5 mg twice daily or 1 mg once daily

1 mg total daily dose
2.1 Dosing Recommendations
Dosing recommendations based on previous therapy are as follows:
• Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily • Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily • Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily
In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered. If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose. 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.
Physicians Total Care, Inc.
No Recall
Budesonide Suspension | Physicians Total Care, Inc.
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.
Cardinal Health
No Recall
Budesonide Suspension | Cardinal Health
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.
Apotex Corp.
No Recall
Budesonide Suspension | Apotex Corp.
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.
Dispensing Solutions, Inc.
No Recall
Budesonide Suspension | Dispensing Solutions, Inc.
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.
Teva Pharmaceuticals Usa Inc
No Recall
Budesonide Suspension | Teva Pharmaceuticals Usa Inc
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.
Preferred Pharmaceuticals, Inc.
No Recall
Budesonide Suspension | Preferred Pharmaceuticals, Inc.
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.