ATROVENT NASAL AEROSOL 20MCG/AEM

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

IPRATROPIUM BROMIDE

Dostupné s:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC kód:

R03BB01

INN (Mezinárodní Name):

IPRATROPIUM BROMIDE

Dávkování:

20MCG

Léková forma:

AEROSOL

Složení:

IPRATROPIUM BROMIDE 20MCG

Podání:

INHALATION

Jednotky v balení:

200 DOSES

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTIMUSCARINICS ANTISPASMODICS

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

1999-08-09

Charakteristika produktu

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