QVAR METERED-DOSE AEROSOL

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

BECLOMETHASONE DIPROPIONATE

Tilgængelig fra:

BAUSCH HEALTH, CANADA INC.

ATC-kode:

R03BA01

INN (International Name):

BECLOMETASONE

Dosering:

100MCG

Lægemiddelform:

METERED-DOSE AEROSOL

Sammensætning:

BECLOMETHASONE DIPROPIONATE 100MCG

Indgivelsesvej:

INHALATION

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

ADRENALS

Produkt oversigt:

Active ingredient group (AIG) number: 0106320003; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2021-01-01

Produktets egenskaber

PRODUCT MONOGRAPH
PR
QVAR
®
Beclomethasone Dipropionate
Inhalation Aerosol - Metered Dose Aerosol
50 mcg and 100 mcg
CORTICOSTEROID FOR ORAL INHALATION
CONTAINS NO CHLOROFLUOROCARBONS (CFCS)
(CFC-FREE)
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
December 29, 2020
Laval, Quebec
H7L 4A8
Control #: 241786
_Pr_
_QVAR _
_®_
_ Product Monograph Page 2 of 29_
PRODUCT MONOGRAPH
PR
QVAR
®
Beclomethasone Dipropionate
Inhalation Aerosol - Metered Dose Aerosol
50 mcg and 100 mcg
ACTION AND CLINICAL PHARMACOLOGY
Beclomethasone dipropionate is a diester of beclomethasone, a
synthetic corticosteroid
chemically related to dexamethasone. Beclomethasone differs from
dexamethasone in having a
chlorine at the 9-alpha carbon in place of a fluorine, and in having a
16 beta-methyl group
instead of a 16 alpha-methyl group.
Bronchial inflammation is known to be an important component in the
pathogenesis of asthma,
occurring in both large and small airways. Glucocorticoids have
multiple anti-inflammatory
effects, inhibiting both inflammatory cells and release of
inflammatory mediators. It is presumed
that these anti-inflammatory actions play an important role in the
efficacy of beclomethasone
dipropionate (BDP) in controlling symptoms and improving lung function
in asthma. Inhaled
BDP probably acts as a topical anti-inflammatory agent at the site of
deposition in the bronchial
tree.
In two studies evaluating the deposition pattern of technetium-99m
labeled QVAR
(beclomethasone dipropionate), approximately 50-60% of the dose from
the actuator (40% of the
dose from the valve) of QVAR was deposited in the lungs. The imaging
data suggest that
QVAR, beclomethasone dipropionate formulated in hydrofluoroalkane-134a
(HFA-BDP),
deposited widely throughout the central, intermediate, and peripheral
airways. In contrast,
approximately 4-7% dose from the actuator (5% of the dose from the
valve) of beclomethasone
dipropionate formulated in chlorofluorocarbons (CFC-BDP) was deposited
in the lungs, and
deposition was limited