Budesonide Inhalation

Budesonide Inhalation

Budesonide Inhalation Recall

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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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 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:

Chemical Structure Formula of Budesonide

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 sodium chloride, disodium edetate, polysorbate 80, citric acid, tri sodium citrate, and water for injection. Two dose strengths are available in single-dose ampules: 0.25 mg and 0.5 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)].

Budesonide Inhalation Manufacturers


  • Watson Laboratories, Inc.
    Budesonide Inhalation (Budesonide) Suspension [Watson Laboratories, Inc.]
  • Preferred Pharmaceuticals Inc.
    Budesonide Inhalation (Budesonide) Suspension [Preferred Pharmaceuticals Inc.]

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