DOSAGE AND ADMINISTRATION
PULMICORT RESPULES is indicated for use in asthmatic patients 12 months to 8 years of age. PULMICORT RESPULES should be administered by the inhaled route via jet nebulizer connected to an air compressor. Individual patients will experience a variable onset and degree of symptom relief. Improvement in asthma control following inhaled administration of PULMICORT RESPULES can occur within 2-8 days of initiation of treatment, although maximum benefit may not be achieved for 4-6 weeks. The safety and efficacy of PULMICORT RESPULES when administered in excess of recommended doses have not been established. In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved. 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 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
|
In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily of PULMICORT RESPULES may also be considered.
If once-daily treatment with PULMICORT RESPULES does not provide adequate control of asthma symptoms, the total daily dose should be increased and/or administered as a divided dose.
Patients Not Receiving Systemic (Oral) Corticosteroids
Patients who require maintenance therapy of their asthma may benefit from treatment with PULMICORT RESPULES at the doses recommended above. Once the desired clinical effect is achieved, consideration should be given to tapering to the lowest effective dose. For the patients who do not respond adequately to the starting dose, consideration should be given to administering the total daily dose as a divided dose, if a once-daily dosing schedule was followed. If necessary, higher doses, up to the maximum recommended doses, may provide additional asthma control.
Patients Maintained on Chronic Oral Corticosteroids
Initially, PULMICORT RESPULES should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid may be initiated by reducing the daily or alternate daily dose. Further incremental reductions may be made after an interval of one or two weeks, depending on the response of the patient. Generally, these decrements should not exceed 25% of the prednisone dose or its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency (see WARNINGS). During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, eg, joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with PULMICORT RESPULES but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly. During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.
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 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 PRECAUTIONS, Information for Patients).
Directions for Use
Illustrated Patient’s Instructions for Use accompany each package of PULMICORT RESPULES.
|
