"The US Food and Drug Administration has approved AstraZeneca's Symbicort inhalation aerosol (80/4.5 mcg) for children aged 6 to 12 years with asthma that is not well controlled with an inhaled corticosteroid, the company has announced.
Treatment of Asthma
PULMICORT FLEXHALER (budesonide inhalation powder) is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older.
Important Limitations of Use:
- PULMICORT FLEXHALER (budesonide inhalation powder) is NOT indicated for the relief of acute bronchospasm.
DOSAGE AND ADMINISTRATION
PULMICORT FLEXHALER (budesonide inhalation powder) should be administered twice daily by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing [see PATIENT INFORMATION].
Patients should be instructed to prime PULMICORT FLEXHALER (budesonide inhalation powder) prior to its initial use, and instructed to inhale deeply and forcefully each time the device is used.
The safety and efficacy of PULMICORT FLEXHALER (budesonide inhalation powder) when administered in excess of recommended doses have not been established.
After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with PULMICORT FLEXHALER (budesonide inhalation powder) , increasing the dose may provide additional asthma control.
If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Patients 18 Years of Age and Older: For patients 18 years of age and older, the recommended starting dosage is 360 mcg twice daily. In some adult patients, a starting dose of 180 mcg twice daily may be adequate. The maximum dosage should not exceed 720 mcg twice daily.
Patients 6 to 17 Years of Age: The recommended starting dosage is 180 mcg twice daily. In some pediatric patients, a starting dose of 360 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.
For all patients, it is desirable to titrate to the lowest effective dose after adequate asthma stability is achieved.
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. Individual patients will experience a variable onset and degree of symptom relief.
If a previously effective dosage regimen of PULMICORT FLEXHALER (budesonide inhalation powder) fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options (e.g. replacing the lower strength of PULMICORT FLEXHALER with the higher strength or initiating oral corticosteroids) should be considered.
Dosage Forms And Strengths
PULMICORT FLEXHALER (budesonide inhalation powder) is available as a dry powder for inhalation containing budesonide in the following 2 strengths: 90 mcg and 180 mcg. Each inhaler contains 60 or 120 actuations.
Storage And Handling
PULMICORT FLEXHALER (budesonide inhalation powder) is available as a dry powder for inhalation containing budesonide in the following 2 strengths: 90 mcg and 180 mcg. Each dosage strength contains 60 or 120 actuations per device. 180 mcg/dose (NDC 0186-0916-12) with a target fill weight of 225 mg (range 200-250), and 90 mcg/dose, 60 dose (NDC 0186-0917-06) with a target fill weight of 165 mg (range 140-190).
PULMICORT FLEXHALER (budesonide inhalation powder) 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 (budesonide inhalation powder) inhaler cannot be refilled and should be discarded when empty.
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.
Manufactured for: AstraZeneca LP, Wilmington DE 19850. By: AstraZeneca AB, Södertälje, Sweden. Product of Sweden. Revised April 2010This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/6/2017
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