QVAR- beclomethasone dipropionate aerosol, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BECLOMETHASONE DIPROPIONATE (UNII: 5B307S63B2) (BECLOMETHASONE 17-MONOPROPIONATE - UNII:5BGA9FD55H)

Available from:

Physicians Total Care, Inc.

INN (International Name):

BECLOMETHASONE DIPROPIONATE

Composition:

BECLOMETHASONE DIPROPIONATE 40 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. QVAR is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR may reduce or eliminate the need for the systemic corticosteroids. Beclomethasone dipropionate is NOT indicated for the relief of acute bronchospasm. QVAR is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

Product summary:

QVAR is supplied in two strengths: The correct amount of medication in each inhalation cannot be assured after 100 actuations from the 7.3 g canister or 120 actuations from the 8.7 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used. Store QVAR Inhalation Aerosol when not being used, so that the product rests on the concave end of the canister with the plastic actuator on top. Store at 25°C (77°F). Excursions between 15° and 30°C (59° and 86°F) are permitted (see USP). 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. CONTENTS UNDER PRESSURE Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. Rx only U.S. Patent Nos. 5605674, 5683677, 5695743, 5776432 Mktd by: Teva Respiratory, LLC– Horsham, PA 19044 © 2010 Teva Respiratory, LLC 639300 QVAR® is a registered trademark of IVAX LLC, a member of the TEVA Group. Rev. 09/10 OptiChamber is a registered trademark of Respironics Healthscan, Inc. and AeroChamber Plus is a registered trademark of Trudell Medical International Trudell Partnership Holdings Limited and Packard Medical Supply Centre Ltd. Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK       74146

Authorization status:

New Drug Application

Summary of Product characteristics

QVAR - BECLOMETHASONE DIPROPIONATE AEROSOL, METERED
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
The active component of QVAR 40 mcg Inhalation Aerosol and QVAR 80 mcg
Inhalation Aerosol is
beclomethasone dipropionate, USP, an anti-inflammatory corticosteroid
having the chemical name 9-
chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione
17,21-dipropionate.
Beclomethasone dipropionate (BDP) 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. Beclomethasone dipropionate is a white to creamy white,
odorless powder with a
molecular formula of C
H ClO and a molecular weight of 521.1. Its chemical structure is:
QVAR is a pressurized, metered-dose aerosol intended for oral
inhalation only. Each unit contains a
solution of beclomethasone dipropionate in propellant HFA-134a
(1,1,1,2 tetrafluoroethane) and
ethanol. QVAR 40 mcg delivers 40 mcg of beclomethasone dipropionate
from the actuator and 50 mcg
from the valve. QVAR 80 mcg delivers 80 mcg of beclomethasone
dipropionate from the actuator and
100 mcg from the valve. Both products deliver 50 microliters (59
milligrams) of solution formulation
from the valve with each actuation. Each canister provides 100
inhalations. QVAR should be "primed"
or actuated twice prior to taking the first dose from a new canister,
or when the inhaler has not been
used for more than ten days. Avoid spraying in the eyes or face while
priming QVAR. This product
does not contain chlorofluorocarbons (CFCs).
CLINICAL PHARMACOLOGY
Airway inflammation is known to be an important component in the
pathogenesis of asthma. Inflammation
occurs in both large and small airways. Corticosteroids have multiple
anti-inflammatory effects,
inhibiting both inflammatory cells (e.g., mast cells, eosinophils,
basophils, lymphocytes, macrophages,
and neutrophils) and rele