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Pulmicort (Budesonide Inhalation) - Indications and Dosage

 
 



INDICATIONS AND USAGE

PULMICORT FLEXHALER 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 FLEXHALER is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

PULMICORT FLEXHALER 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, budesonide has a relatively rapid onset of action for an inhaled corticosteroid. Improvement in asthma control following inhaled administration of 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 FLEXHALER when administered in excess of recommended doses have not been established.

A definitive comparative therapeutic ratio between PULMICORT FLEXHALER and PULMICORT TURBUHALER has not been established. For patients who have been on PULMICORT TURBUHALER the dose of PULMICORT FLEXHALER may not be predicted by the dose of that product. The clinical response of PULMICORT FLEXHALER compared with PULMICORT TURBUHALER tends to be lower (see Clinical Studies). Any patient who is switched from PULMICORT TURBUHALER to PULMICORT FLEXHALER should be dosed appropriately, taking into account the dosing recommendations, and titrating the dose as dictated by the clinical response.

Adults (age 18 and older): The recommended starting dosage is 360 mcg twice daily. In some patients, a starting dosage of 180 mcg twice daily may be adequate. The maximum dosage should not exceed 720 mcg twice daily.

Children (age 6 to 17): The recommended starting dosage is 180 mcg twice daily. In some patients a starting dosage of 360 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.

Dose Titration

As with any inhaled corticosteroid, physicians are advised to select the dosage of PULMICORT FLEXHALER that would be appropriate based upon the patient’s disease severity and titrate the dosage of PULMICORT FLEXHALER downward over time to the lowest level that maintains proper asthma control. In adult patients who are well controlled, a dosage of 180 mcg twice daily may be considered. In some adult patients, a starting dosage of 180 mcg twice daily may be adequate. If the 180 mcg twice daily dosage of PULMICORT FLEXHALER in adults does not provide adequate control, the dosage should be increased.

Patients Maintained on Chronic Oral Corticosteroids

Clinical studies with PULMICORT FLEXHALER did not evaluate patients on oral corticosteroids. However, clinical studies with therapeutic doses of PULMICORT TURBUHALER did show efficacy in the management of asthmatics dependent or maintained on systemic corticosteroids. If a patient is already on a systemic corticosteroid for asthma control, PULMICORT FLEXHALER should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroid. The patient’s asthma should be reasonably stable before withdrawal of oral corticosteroids is initiated. After approximately one week, gradual withdrawal of the systemic corticosteroid may be 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 FLEXHALER 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.

Directions for Use

Illustrated Patient Information and Instructions for Use accompany each package of PULMICORT FLEXHALER.

Patients should be instructed to prime PULMICORT FLEXHALER 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 (see further instructions in PRECAUTIONS, Information for Patients).

HOW SUPPLIED

PULMICORT FLEXHALER 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 PULMICORT FLEXHALER inhaler cannot be refilled and should be discarded when empty.

PULMICORT FLEXHALER is available in two strengths: 180 mcg/dose, 120 doses (NDC 0186-0916-12) with a target fill weight of 225 mg (range 200-250), and 90 mcg/dose, 60 doses (NDC 0186-0917-06) with a target fill weight of 165 mg (range 140-190).

The number in the middle of the dose indicator window shows how many doses are left in the inhaler. The inhaler is empty when the number zero (“0”) on the red background reaches the middle of the window. If the unit is used beyond the point at which the zero reaches the middle of the window, the correct amount of medication may not be obtained and the unit should be discarded.

Store in a dry place at controlled room temperature 20-25°C (68-77°F) [see USP] with the cover tightly in place. Keep out of the reach of children.

All trademarks are the property of the AstraZeneca group of companies

© AstraZeneca 2007

Manufactured for: AstraZeneca LP, Wilmington, DE 19850

By: AstraZeneca AB, Södertälje, Sweden

33023–02

Rev. 08/07

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