SYMBICORT- budesonide and formoterol fumarate dihydrate aerosol

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X), FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B)

可用日期:

AstraZeneca Pharmaceuticals LP

INN（国际名称）:

BUDESONIDE

组成:

BUDESONIDE 160 ug

给药途径:

RESPIRATORY (INHALATION)

处方类型:

PRESCRIPTION DRUG

疗效迹象:

SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older. SYMBICORT should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA). Important Limitations of Use: SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. SYMBICORT 160/4.5 is also indicated to reduce exacerbations of COPD. SYMBICORT 160/4.5 is the only strength indicated for the treatment of COPD. Important Limitations of Use: The use of SYMBICORT is contraindicated in the following conditions: Risk Summary There are no adequate and well-controlled studies of SYMBICORT or one of its individual components, formoterol fumarate, in pregnant women; however studies are available for t

產品總結:

SYMBICORT is available in two strengths and is supplied in the following package sizes: Package Size NDC SYMBICORT Inhalations 80/4.5 120 0186-0372-20 SYMBICORT inhalations (institutional pack) 80/4.5 60 0186-0372-28 SYMBICORT Inhalations 160/4.5 120 0186-0370-20 SYMBICORT inhalations (institutional pack) 160/4.5 60 0186-0370-28 Each strength is supplied as a pressurized aluminum canister with an attached counting device, a red plastic actuator body with a white mouthpiece, and attached gray dust cap. Each 120 inhalation canister has a net fill weight of 10.2 grams and each 60 inhalation canister has a net fill weight of 6.9 grams (SYMBICORT 80/4.5) or 6 grams (SYMBICORT 160/4.5). Each canister is packaged in a foil overwrap pouch with desiccant sachet and placed into a carton. Each carton contains one canister and a Patient Information leaflet. The SYMBICORT canister should only be used with the SYMBICORT actuator, and the SYMBICORT actuator should not be used with any other inhalation drug product. The correct amount of medication in each inhalation cannot be ensured after the labeled number of inhalations from the canister have been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of inhalations have been used or within 3 months after removal from the foil pouch. Never immerse the canister into water to determine the amount remaining in the canister (“float test”). Store at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP]. Store the inhaler with the mouthpiece down. For best results, the canister should be at room temperature before use. Shake well for 5 seconds before using. Keep out of the reach of children. Avoid spraying in eyes. CONTENTS UNDER PRESSURE. Do not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures over 120ºF may cause bursting. Never throw container into fire or incinerator.

授权状态:

New Drug Application

产品特点

SYMBICORT- BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE AEROSOL
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SYMBICORT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SYMBICORT.
SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) INHALATION
AEROSOL, FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
SYMBICORT is a combination product containing a corticosteroid and a
long-acting beta -adrenergic agonist indicated for:
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Important limitations:
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DOSAGE AND ADMINISTRATION
For oral inhalation only.
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DOSAGE FORMS AND STRENGTHS
Metered-dose inhaler containing a combination of budesonide (80 or 160
mcg) and formoterol (4.5 mcg) as an inhalation
aerosol. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
2
Treatment of asthma in patients 6 years of age and older. (1.1)
Maintenance treatment of airflow obstruction and reducing
exacerbations in patients with chronic obstructive
pulmonary disease (COPD) including chronic bronchitis and/or
emphysema. (1.2)
Not indicated for the relief of acute bronchospasm. (1.1, 1.2)
Treatment of asthma in patients 12 years and older: 2 inhalations of
SYMBICORT 80/4.5 or 160/4.5 twice daily.
Starting dosage is based on asthma severity. (2.2)
Treatment of asthma in patients aged 6 to less than 12 years: 2
inhalations of SYMBICORT 80/4.5 twice daily. (2.2)
Maintenance treatment in COPD: 2 inhalations of SYMBICORT 160/4.5
twice daily. (2.3)
Primary treatment of status asthmaticus or acute episodes of asthma or
COPD requiring intensive measures. (4)
Hypersensitivity to any of the ingredients in SYMBICORT. (4)
Serious asthma-related events: Long-acting beta2-adrenergic agonists
as monotherapy increase the risk. (5.1)
Deterioration of disease and acute episodes: Do not initiate in
acutely deteriorating asthma or COPD or to treat acute
symptoms. (5.2)
Use with additional long-acting beta -ago