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Pulmicort Respules

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Pulmicort Respules

Indications
Dosage
How Supplied

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.

Previous Therapy Recommended Starting Dose Highest Recommended Dose
Bronchodilators alone 0.5 mg total daily dose administered either once dail 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

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:

NDC 0186-1988-04 0.25 mg/2 mL
NDC 0186-1989-04 0.5 mg/2 mL
NDC 0186-1990-04 1 mg/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

Last reviewed on RxList: 7/29/2010
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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