BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE aerosol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AstraZeneca Pharmaceuticals LP

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is indicated for the treatment of asthma in patients 6 years of age and older. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 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: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 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. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is also indicated to reduce exacerbations of COPD. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is the only strength indicated for the treatment of COPD. Important Limitat

Product summary:

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is available in two strengths and is supplied in the following package sizes: Package Size NDC BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 120 Inhalations 0310-7372-20 BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 120 Inhalations 0310-7370-20 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. 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 BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL canister should only be used with the BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL actuator, and the BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE- 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
BUDESONIDE AND FORMOTEROL
FUMARATE DIHYDRATE INHALATION AEROSOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL.
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL, FOR
ORAL INHALATION USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 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
BUDESONIDE AND FORMOTEROL
FUMARATE DIHYDRATE INHALATION AEROSOL 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 BUDESONIDE AND FORMOTEROL
FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 twice daily. (2.2)
Maintenance treatment in COPD: 2 inhalations of BUDESONIDE AND
FORMOTEROL FUMARATE DIHYDRATE
INHALATION AEROSOL 160/4.5 twice daily. (2.3)
Primary treatment of status asthmaticus or acute episodes of asthma or
COPD requiring intensive measures. (4)
Hypersensitivi