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PULMICORT RESPULES®
(budesonide) Inhalation Suspension

DESCRIPTION

Budesonide, the active component of PULMICORT RESPULES® (budesonide inhalation suspension) , is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20dione 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 (budesonide inhalation suspension) 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 (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. PULMICORT RESPULES should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see DOSAGE AND ADMINISTRATION].

INDICATIONS

Maintenance Treatment of Asthma

PULMICORT RESPULES (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:

• PULMICORT RESPULES (budesonide inhalation suspension) is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

The recommended starting dose and highest recommended dose of PULMICORT RESPULES (budesonide inhalation suspension) , based on prior asthma therapy, are listed in the following table.

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.

Directions for Use

PULMICORT RESPULES (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 PULMICORT RESPULES (budesonide inhalation suspension) and, therefore, are NOT recommended.

The effects of mixing PULMICORT RESPULES (budesonide inhalation suspension) with other nebulizable medications have not been adequately assessed. PULMICORT RESPULES (budesonide inhalation suspension) should be administered separately in the nebulizer [see PATIENT INFORMATION, Administration with a jet nebulizer].

A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver PULMICORT RESPULES (budesonide inhalation suspension) 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.

HOW SUPPLIED

Dosage Forms And Strengths

PULMICORT RESPULES (budesonide inhalation suspension) is available in three strengths, each containing 2 mL: 0.25 mg/2 mL, 0.5 mg/2mL, and 1 mg/2 mL. PULMICORT RESPULES (budesonide inhalation suspension) is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose RESPULES ampules together with patient instructions for use. There are 30 RESPULES ampules in a carton. Each single-dose RESPULES ampule contains 2 mL of sterile liquid suspension.

Storage And Handling

PULMICORT RESPULES (budesonide inhalation suspension) is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose RESPULES ampules together with patient instructions for use. There are 30 RESPULES ampules in a carton. Each single-dose RESPULES ampule contains 2 mL of sterile liquid suspension.

PULMICORT RESPULES (budesonide inhalation suspension) is available in three strengths, each containing 2 mL:

PULMICORT RESPULES (budesonide inhalation suspension) should be stored upright at controlled room temperature 20-25°C (68-77°F) [see USP], and protected from light. When an envelope has been opened, the shelf life of the unused RESPULES ampules is 2 weeks when protected. After opening the aluminum foil envelope, the unused RESPULES ampules should be returned to the aluminum foil envelope to protect them from light. Any opened RESPULES ampule must be used promptly. Gently shake the RESPULES ampule using a circular motion before use. Keep out of reach of children. Do not freeze.

Revised: 04/10. Manufactured for: AstraZeneca LP, Wilmington, DE 19850. By: AstraZeneca AB, Sodertalje, Sweden. Product of Sweden

SIDE EFFECTS

Systemic and inhaled corticosteroid use may result in the following:

• Candida albicans infection [see WARNINGS AND PRECAUTIONS]
• Hypersensitivity reactions including anaphylaxis [see WARNINGS AND PRECAUTIONS]
• Immunosuppression [see WARNINGS AND PRECAUTIONS]
• Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
• Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]
• Growth effects in pediatric patients [see WARNINGS AND PRECAUTIONS and Use in Specific Populations, Pediatric Use]
• Glaucoma, increased intraocular pressure and cataracts [see WARNINGS AND PRECAUTIONS]
• Eosinophilic conditions and Churg-Strauss syndrome [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidence of common adverse reactions is based on three double-blind, placebo-controlled, randomized U.S. clinical trials in which 945 patients, 12 months to 8 years of age, (98 patients ≥ 12 months and < 2 years of age; 225 patients ≥ 2 and < 4 years of age; and 622 patients ≥ 4 and ≤ 8 years of age) were treated with PULMICORT RESPULES (budesonide inhalation suspension) (0.25 to 1 mg total daily dose for 12 weeks) or vehicle placebo. The incidence and nature of adverse events reported for PULMICORT RESPULES (budesonide inhalation suspension) was comparable to that reported for placebo. The following table shows the incidence of adverse events in U.S. controlled clinical trials, regardless of relationship to treatment, in patients previously receiving bronchodilators and/or inhaled corticosteroids. This population included a total of 605 male and 340 female patients and 78.4% were Caucasian, 13.8% African American, 5.5% Hispanic and 2.3% Other.

Table 1 : Adverse Reactions occurring at an incidence of ≥ 3% in at least one active treatment group where the incidence was higher with PULMICORT RESPULES (budesonide inhalation suspension) than placebo