PHL-IPRATROPIUM - 20ML SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IPRATROPIUM BROMIDE

Disponibil de la:

PHARMEL INC

Codul ATC:

R03BB01

INN (nume internaţional):

IPRATROPIUM BROMIDE

Dozare:

250MCG

Forma farmaceutică:

SOLUTION

Compoziție:

IPRATROPIUM BROMIDE 250MCG

Calea de administrare:

INHALATION

Unități în pachet:

20ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIMUSCARINICS ANTISPASMODICS

Rezumat produs:

Active ingredient group (AIG) number: 0115643001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2009-10-26

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR PHL-IPRATROPIUM
(Ipratropium Bromide Inhalation Solution)
125
:
g/mL & 250
:
g/mL
BRONCHODILATOR
PHARMEL INC.
DATE OF PREPARATION:
8699 8th Avenue
December 14, 2004
Montréal, Canada
DATE OF REVISION:
H1Z 2X4
Control #: 095748
2
PRODUCT MONOGRAPH
PR PHL-IPRATROPIUM
(Ipratropium Bromide Inhalation Solution)
125
:
g/mL & 250
:
g/mL
THERAPEUTIC CLASSIFICATION
Bronchodilator
ACTION AND CLINICAL PHARMACOLOGY
Ipratropium bromide, a quaternary ammonium derivative of atropine, is
an anticholinergic drug
which has 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 from the peak. Bronchodilation is still evident 8
hours after inhalation.
In acute and maintenance therapy of chronic reversible airways
obstruction, ipratropium has
been shown to provide additive bronchodilating effects to theophylline
and beta-adrenoceptor
agonists (sympathomimetic amines). Repeated inhalation of ipratropium
has not been linked to
tolerance towards bronchodilating effects.
In controlled 12-week 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%
in increases of 15% or more) occurred within 15 minutes, reached
a peak in 1 to 2 hours, and persisted for periods of 4 to 5 hours in
the majority of patients, with
25 to 38% of the patients demonstrating increases of at least 15% at 7
to 8 hours. Continued
effectiveness of ipratropium solution was demonstrated throughout the
12-week period. In
addition, significant changes in forced vital capacity (FVC) have been
demonstrated.
Additional controlled 12-week studies were conducted to evaluate the
safety and efficacy of
ipratropium solution administered concomitantly with bronchodilator
solutions of orciprenaline
or salbutamol, compared with the administration of each of the beta
agonists alone.
3