Pulmicort Respules
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
PULMICORT RESPULES 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:
• PULMICORT RESPULES 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 PULMICORT RESPULES®, 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 is provided as a mixture of two epimers (22R and 22S). The empirical 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.
PULMICORT RESPULES is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80, and Water for Injection. Three dose strengths are available in single-dose ampules (Respules™ ampules): 0.25 mg, 0.5 mg, and 1 mg per 2 mL RESPULES ampule. For PULMICORT RESPULES, 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. PULMICORT RESPULES should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)].
Sources
Pulmicort Respules Manufacturers
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Physicians Total Care, Inc.
![Pulmicort Respules (Budesonide) Suspension [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pulmicort Respules | Physicians Total Care, Inc.
The recommended starting dose and highest recommended dose of PULMICORT RESPULES, based on prior asthma therapy, are listed in the following table.
Previous Therapy Recommended Starting Dose Highest Recommended DoseBronchodilators 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 RecommendationsDosing 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 UsePULMICORT RESPULES 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 PULMICORT RESPULES and, therefore, are NOT recommended.
The effects of mixing PULMICORT RESPULES with other nebulizable medications have not been adequately assessed. PULMICORT RESPULES 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 PULMICORT RESPULES to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of PULMICORT RESPULES delivered by other nebulizers and compressors have not been established.
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Astrazeneca Lp
Pulmicort Respules | Astrazeneca Lp
The recommended starting dose and highest recommended dose of PULMICORT RESPULES, based on prior asthma therapy, are listed in the following table.
Previous Therapy Recommended Starting Dose Highest Recommended DoseBronchodilators 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 RecommendationsDosing 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 dailyIn 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 UsePULMICORT RESPULES 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 PULMICORT RESPULES and, therefore, are NOT recommended.
The effects of mixing PULMICORT RESPULES with other nebulizable medications have not been adequately assessed. PULMICORT RESPULES 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 PULMICORT RESPULES to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of PULMICORT RESPULES delivered by other nebulizers and compressors have not been established.
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Cardinal Health
Pulmicort Respules | Cardinal Health
The recommended starting dose and highest recommended dose of PULMICORT RESPULES, based on prior asthma therapy, are listed in the following table.
Previous Therapy Recommended Starting Dose Highest Recommended DoseBronchodilators 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 RecommendationsDosing 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 dailyIn 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 UsePULMICORT RESPULES 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 PULMICORT RESPULES and, therefore, are NOT recommended.
The effects of mixing PULMICORT RESPULES with other nebulizable medications have not been adequately assessed. PULMICORT RESPULES 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 PULMICORT RESPULES to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of PULMICORT RESPULES delivered by other nebulizers and compressors have not been established.
![Pulmicort Respules (Budesonide) Suspension [Astrazeneca Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=33cd9834-76df-4f26-3fa2-aab6b9eee8f2&name=37814a0a-646e-44b1-bb71-323bab776259-09.jpg)
![Pulmicort Respules (Budesonide) Suspension [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9e6641a9-32c8-422a-a1d6-3aba08fd1400&name=14355f76-caa3-4c12-957a-9605e5c0f09c-09.jpg)
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