QVAR beclomethasone dipropionate aerosol metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BECLOMETHASONE DIPROPIONATE (UNII: 5B307S63B2) (BECLOMETHASONE - UNII:KGZ1SLC28Z)

Available from:

RPK Pharmaceuticals, Inc.

INN (International Name):

BECLOMETHASONE DIPROPIONATE

Composition:

BECLOMETHASONE DIPROPIONATE 40 ug

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

QVAR- BECLOMETHASONE DIPROPIONATE AEROSOL, METERED
RPK PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QVAR
SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR QVAR INHALATION AEROSOL.
QVAR® (BECLOMETHASONE DIPROPIONATE HFA), INHALATION AEROSOL, FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 1976
RECENT MAJOR CHANGES
Warnings and Precautions (5.10) 09/2017
INDICATIONS AND USAGE
QVAR is a corticosteroid indicated for:
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Important Limitations:
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DOSAGE AND ADMINISTRATION
For oral inhalation only. (2.1)
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Indications and Usage (1) 09/2017
Dosage and Administration (2.1,2.2) 09/2017
Maintenance treatment of asthma as prophylactic therapy in patients 5
years of age and older. (1)
Not indicated for the relief of acute bronchospasm. (1)
Starting dosage is based on prior asthma therapy and disease severity.
(2.2)
Treatment of asthma in patients 12 years and older: 40 mcg, 80 mcg,
160 mcg, or 320 mcg twice daily.(2.2)
Treatment of asthma in patients 5 to 11 years of age: 40 or 80 mcg
twice daily. (2.2)
Discard QVAR inhaler when the dose counter displays 0 or after the
expiration date on the product, whichever comes
first. (2.1)
Inhalation aerosol: 40 or 80 mcg per actuation (3)
Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive measures are required.
(4 )
Hypersensitivity to any of the ingredients of QVAR. (4)
Localized infections: _Candida albicans_ infection of the mouth and
throat may occur. Monitor patients periodically for
signs of adverse effects on the oral cavity. Advise patients to rinse
the mouth with water without swallowing after
inhalation. (5.1)
Deterioration of asthma and acute episodes: Do not use QVAR for relief
of acute symptoms. Patients require
immediate re-evaluation during rapidly deteriorating asthma. (5.2)
Transferring patients from systemic