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:

Preferred Pharmaceuticals Inc.

INN (International Name):

BECLOMETHASONE DIPROPIONATE

Composition:

BECLOMETHASONE DIPROPIONATE 80 ug

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

QVAR® is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use: 4.1 Status Asthmaticus QVAR is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. 4.2 Hypersensitivity QVAR is contraindicated in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR [see Warnings and Precautions (5.6)]. Risk Summary There are no adequate and well-controlled studies with QVAR or beclomethasone dipropionate in pregnant women. There are clinical considerations with the use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women [see Clinical Considerations] . Also, no published studies, including studies of large birth registries, have to date related the use of ICS to any increases in congenital malformations or other adverse perinatal outcomes. Thus, available human data do not

Product summary:

QVAR is supplied in 2 strengths: QVAR 80 mcg is supplied in a box of one 8.7 g canister containing 120 actuations with a dark mauve plastic actuator with a dose counter and gray dust cap, and Patient Information and Instructions for Use; box of one; 120 Actuations – NDC 68788-7025-1. The correct amount of medication in each inhalation cannot be assured after 120 actuations from the 8.7 g canister even though the canister is not completely empty. Patients should be informed to discard the QVAR inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. Store at 25ºC (77ºF). Excursions between 15º and 30ºC (59º and 86ºF) are permitted (see USP Controlled Room Temperature). For optimal results, the canister should be at room temperature when used. QVAR Inhalation Aerosol canister should only be used with the QVAR Inhalation Aerosol actuator and the actuator should not be used with any other inhalation drug product. Store QVAR Inhalation Aerosol when not being used, so that the product rests on the concave end of the canister with plastic actuator on top. CONTENTS UNDER PRESSURE Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49ºC (120ºF) may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

QVAR- BECLOMETHASONE DIPROPIONATE AEROSOL, METERED
PREFERRED 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 sys