"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
ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.
Important Limitations of Use:
ALVESCO is NOT indicated for the relief of acute bronchospasm.
ALVESCO is NOT indicated for children under 12 years of age.
DOSAGE AND ADMINISTRATION
ALVESCO should be administered by the orally inhaled route. Prime ALVESCO Inhalation Aerosol before using for the first time by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for four weeks or longer after initiation. 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 4 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ALVESCO when administered in excess of the highest recommended doses has not been established.
The recommended starting dose and the highest recommended dose of ALVESCO Inhalation Aerosol are listed in the following table.
|Previous Therapy||Recommended Starting Dose||Highest Recommended Dose|
|Patients ≥ 12 years who received bronchodilators alone||80 mcg twice daily||160 mcg twice daily|
|Patients ≥ 12 years who received inhaled corticosteroids||80 mcg twice daily||320 mcg twice daily|
|Patients ≥ 12 years who received oral corticosteroids1||320 mcg twice daily||320 mcg twice daily|
|1Prednisone should be reduced gradually, no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with ALVESCO. Patients should be carefully monitored for signs of asthma instability, including monitoring of serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see WARNINGS AND PRECAUTIONS].|
Dosage Forms And Strengths
ALVESCO Inhalation Aerosol is available in the following two strengths: 80 mcg/actuation, and 160 mcg/actuation. The 80 mcg/actuation strength contains 60 actuations fill/canister, and the 160 mcg/actuation strength contains 60 actuations fill/canister.
ALVESCO 80 mcg Inhalation Aerosol is supplied with a brown plastic actuator with a red dust cap.
ALVESCO 160 mcg Inhalation Aerosol is supplied with a red plastic actuator with a red dust cap.
Storage And Handling
ALVESCO is available in the following strengths and canister presentations.
|Micrograms per Actuation||Number of Actuations per Canister||Canister Weight||Canister per Box||NDC Number|
|ALVESCO 80 mcg||60||6.1g||1||63402-711-01|
|ALVESCO 160 mcg||60||6.1g||1||63402-712-01|
ALVESCO 80 mcg Inhalation Aerosol is supplied with a brown plastic actuator with a red dust cap. Each actuation of the inhaler delivers 80 mcg of ciclesonide from the actuator.
ALVESCO 160 mcg Inhalation Aerosol is supplied with a red plastic actuator with a red dust cap. Each actuation of the inhaler delivers 160 mcg of ciclesonide from the actuator.
ALVESCO canisters are for use with ALVESCO Inhalation Aerosol actuators only. The actuators are fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each actuation cannot be assured from the canister labeled to contain 60 actuations when the dose indicator display window shows zero even though the canister is not completely empty. The canister should be discarded when the dose indicator display window shows zero.
Store at 25°C (77°F).
Excursions between 15° and 30°C (59° and 86°F) are permitted (see USP). For optimal results, the canister should be at room temperature when used. Keep out of reach of children.
CONTENTS UNDER PRESSURE
Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.
Manufactured for: Sunovion Pharmaceuticals Inc. Marlborough, MA 01752 USA. Made in the United Kingdom.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/15/2016
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