QVAR- beclomethasone dipropionate aerosol, metered

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

A-S Medication Solutions

DCI (Dénomination commune internationale):

BECLOMETHASONE DIPROPIONATE

Composition:

BECLOMETHASONE DIPROPIONATE 80 ug

Mode d'administration:

RESPIRATORY (INHALATION)

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

QVAR® is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use: - QVAR is NOT indicated for the relief of acute bronchospasm. 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

Descriptif du produit:

Product: 50090-1342 NDC: 50090-1342-0 120 AEROSOL, METERED in a CANISTER / 1 in a BOX Product: 50090-3033 NDC: 50090-3033-0 120 AEROSOL, METERED in a CANISTER / 1 in a BOX

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

QVAR- BECLOMETHASONE DIPROPIONATE AEROSOL, METERED
A-S MEDICATION SOLUTIONS
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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
Indications and Usage (1) 09/2017
Dosage and Administration (2.1,2.2) 09/2017
Warnings and Precautions (5.10) 09/2017
INDICATIONS AND USAGE
QVAR is a corticosteroid indicated for:
Maintenance treatment of asthma as prophylactic therapy in patients 5
years of age and older. (1)
Important Limitations:
Not indicated for the relief of acute bronchospasm. (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2.1)
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)
DOSAGE FORMS AND STRENGTHS
Inhalation aerosol: 40 or 80 mcg per actuation (3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
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 corticosteroids: Risk of impaired
adrenal function when trans