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PULMICORT TURBUHALER (budesonide) is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.
PULMICORT TURBUHALER (budesonide) is NOT indicated for the relief of acute bronchospasm.
DOSAGE AND ADMINISTRATION
PULMICORT TURBUHALER (budesonide) should be administered by the orally inhaled route in asthmatic patients age 6 years and older. Individual patients will experience a variable onset and degree of symptom relief. Generally, PULMICORT TURBUHALER (budesonide) has a relatively rapid onset of action for an inhaled corticosteroid. Improvement in asthma control following inhaled administration of PULMICORT TURBUHALER (budesonide) can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks, or longer. The safety and efficacy of PULMICORT TURBUHALER (budesonide) when administered in excess of recommended doses have not been established.
The recommended starting dose and the highest recommended dose of PULMICORT TURBUHALER (budesonide) , based on prior asthma therapy, are listed in the following table.
|Adults:||Bronchodilators alone||200 to 400 mcg twice daily||400 mcg twice daily|
|Inhaled Corticosteroids*||200 to 400 mcg twice daily||800 mcg twice daily|
|Oral Corticosteroids||400 to 800 mcg twice daily||800 mcg twice daily|
|Children:||Bronchodilators alone||200 mcg twice daily||400 mcg twice daily|
|Inhaled Corticosteroids*||200 mcg twice daily||400 mcg twice daily|
|Oral Corticosteroids||The highest recommended dose in children is 400 mcg twice daily|
*In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, dosing with PULMICORT TURBUHALER (budesonide) 200 mcg or 400 mcg once daily may be considered. PULMICORT TURBUHALER (budesonide) can be administered once daily either in the morning or in the evening.
If the once-daily treatment with PULMICORT TURBUHALER (budesonide) does not provide adequate control of asthma symptoms, the total daily dose should be increased and/or administered as a divided dose.
Patients Maintained on Chronic Oral Corticosteroids
Initially, PULMICORT TURBUHALER (budesonide) should be used concurrently with the patient's usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. The next reduction is made after an interval of one or two weeks, depending on the response of the patient. Generally, these decrements should not exceed 2.5 mg of prednisone 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 TURBUHALER (budesonide) 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.
NOTE: In all patients it is desirable to titrate to the lowest effective dose once asthma stability is achieved.
Directions for Use
Illustrated Patient's Instructions for Use accompany each package of PULMICORT TURBUHALER (budesonide) .
Patients should be instructed to prime PULMICORT TURBUHALER (budesonide) prior to its initial use, and instructed to inhale deeply and forcefully each time the unit is used. Rinsing the mouth after inhalation is also recommended.
PULMICORT TURBUHALER (budesonide) consists of a number of assembled plastic details, the main parts being the dosing mechanism, the storage unit for drug substance and the mouthpiece. The inhaler is protected by a white outer tubular cover screwed onto the inhaler. The body of the inhaler is white and the turning grip is brown. The following wording is printed on the grip in raised lettering, “Pulmicort™ 200 mcg”. The TURBUHALER inhaler cannot be refilled and should be discarded when empty.
PULMICORT TURBUHALER (budesonide) is available as 200 mcg/dose, 200 doses (NDC 0186-0915-42) and has a target fill weight of 104 mg.
When there are 20 doses remaining in PULMICORT TURBUHALER (budesonide) , a red mark will appear in the indicator window. If the unit is used beyond the point at which the red mark appears at the bottom of the window, the correct amount of medication may not be obtained. The unit should be discarded.
Store with the cover tightened in a dry place at controlled room temperature 20-25°C (68-77°F) [see USP]. Keep out of the reach of children.
All trademarks are the property of the AstraZeneca group of companies. ©AstraZeneca 2001, 2006. Manufactured for: AstraZeneca LP, Wilmington, DE 19850 By: AstraZeneca AB, Sodertalje, Sweden 33020-00. Rev. 10/06. FDA Rev date: 8/20/2007
Last reviewed on RxList: 9/11/2007
This monograph has been modified to include the generic and brand name in many instances.
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