Land: Canada
Taal: Engels
Bron: Health Canada
IPRATROPIUM BROMIDE
PHARMEL INC
R03BB01
IPRATROPIUM BROMIDE
125MCG
SOLUTION
IPRATROPIUM BROMIDE 125MCG
INHALATION
2ML
Prescription
ANTIMUSCARINICS ANTISPASMODICS
Active ingredient group (AIG) number: 0115643003; AHFS:
CANCELLED POST MARKET
2016-10-25
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 Lees het volledige document