BREYNA- budesonide and formoterol fumarate aerosol, metered

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

budesonide (UNII: Q3OKS62Q6X) (budesonide - UNII:Q3OKS62Q6X), Formoterol Fumarate (UNII: W34SHF8J2K) (Formoterol - UNII:5ZZ84GCW8B)

Inapatikana kutoka:

Mylan Pharmaceuticals Inc.

Njia ya uendeshaji:

RESPIRATORY (INHALATION)

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

BREYNA is indicated for the treatment of asthma in patients 6 years of age and older. BREYNA 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: BREYNA 160 mcg/4.5 mcg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. BREYNA 160 mcg/4.5 mcg is also indicated to reduce exacerbations of COPD. BREYNA 160 mcg/4.5 mcg is the only strength indicated for the treatment of COPD. Important Limitations of Use: The use of BREYNA is contraindicated in the following conditions: There are no adequate and well-controlled studies of budesonide and formoterol fumarate dihydrate inhalation aerosol or one of its individual components, formoterol fumarate, in pre

Bidhaa muhtasari:

BREYNA (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol is available in two strengths and is supplied in the following package sizes: Dosage Forms and Strengths Package Size NDC BREYNA Inhalations 80 mcg/4.5 mcg      120 0378-7502-32 BREYNA Inhalations 160 mcg/4.5 mcg     120 0378-7503-32 Each strength is supplied as a pressurized aluminum canister with an attached counting device, a blue plastic actuator body with a blue mouthpiece, and attached grey dust cap. Each 120 inhalation canister has a net fill weight of 10.3 grams. 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 BREYNA canister should only be used with the BREYNA actuator, and the BREYNA 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 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. 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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

BREYNA- BUDESONIDE AND FORMOTEROL FUMARATE AEROSOL, METERED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BREYNA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BREYNA.
BREYNA™ (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) INHALATION
AEROSOL, FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
BREYNA 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 mcg or
160 mcg) and formoterol
fumarate dihydrate (4.5 mcg) as an inhalation aerosol. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 3%) are:
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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
BREYNA 80 mcg/4.5 mcg or 160
mcg/4.5 mcg 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 BREYNA 80 mcg/4.5
mcg twice daily. (2.2)
Maintenance treatment in COPD: 2 inhalations of BREYNA 160 mcg/4.5 mcg
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 BREYNA (4)
Serious asthma-related events: Long-acting beta -adrenergic agonists
as monotherapy increase the
risk. (5.1)
2
Deterioration of disease and acute episodes: Do n