ATROVENT NASAL AEROSOL 20MCG/AEM

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

IPRATROPIUM BROMIDE

Tillgänglig från:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC-kod:

R03BB01

INN (International namn):

IPRATROPIUM BROMIDE

Dos:

20MCG

Läkemedelsform:

AEROSOL

Sammansättning:

IPRATROPIUM BROMIDE 20MCG

Administreringssätt:

INHALATION

Enheter i paketet:

200 DOSES

Receptbelagda typ:

Prescription

Terapiområde:

ANTIMUSCARINICS ANTISPASMODICS

Produktsammanfattning:

Active ingredient group (AIG) number: 0115643002; AHFS:

Bemyndigande status:

CANCELLED POST MARKET

Tillstånd datum:

1999-08-09

Produktens egenskaper

PRODUCT MONOGRAPH
Pr
Atrovent
®
(Ipratropium Bromide)
INHALATION AEROSOL
BRONCHODILATOR
BOEHRINGER INGELHEIM (CANADA) LTD.
DATE OF PREPARATION:
5180 SOUTH SERVICE ROAD,
September 28, 1994
BURLINGTON, ONTARIO
DATE OF REVISION:
L7L 5H4
CONTROL NO. 083050
PMG 03/07/10 BPI 0019-04
2
PRODUCT MONOGRAPH
NAME OF DRUG
Atrovent
®
(Ipratropium bromide)
INHALATION AEROSOL
20 mcg/metered dose
THERAPEUTIC CLASSIFICATION
BRONCHODILATOR
ACTION AND CLINICAL PHARMACOLOGY
ATROVENT (ipratropium bromide), a quaternary ammonium derivative of
atropine is an
anticholinergic drug having bronchodilator properties. On inhalation
the onset of action is noted
within 5 to 15 minutes with a peak response between 1 and 2 hours,
lasting about 2 additional
hours with subsequent decline. An inhaled dose of 40 mcg induces
bronchodilator effect lasting
for some 6 hours.
Significant alterations on airway mucous secretion, mucociliary
clearance of sputum, or gas
exchange have not been observed. Systemic absorption of ATROVENT is
poor and the blood
levels reached are very low. Metabolic studies with ATROVENT in
healthy volunteers show an
average elimination half-life of 3.5 hours (range 1.5 - 4). The drug
is transformed to some 8
metabolites with little or no anticholinergic activity.
In controlled 90 day studies in patients with bronchospasm associated
with chronic obstructive
pulmonary disease (chronic bronchitis and emphysema) significant
improvements in pulmonary
function (FEV
1
and FEF
25-75%
increases of 15% or more) occurred within 15 minutes, reached a
PMG 03/07/10 BPI 0019-04
3
peak in 1-2 hours, and persisted for periods of 3 to 4 hours in the
majority of patients and up to
6 hours in some patients.
INDICATIONS AND CLINICAL USE
ATROVENT (ipratropium bromide) is indicated as a bronchodilator for
maintenance treatment of
bronchospasm associated with chronic obstructive pulmonary disease,
including chronic
bronchitis and emphysema.
CONTRAINDICATIONS
ATROVENT (ipratropium bromide) inhalation aerosol is contraindicated
in patients with a history