מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
ZAFIRLUKAST
ASTRAZENECA CANADA INC
R03DC01
ZAFIRLUKAST
20MG
TABLET
ZAFIRLUKAST 20MG
ORAL
60
Prescription
LEUKOTRIENE MODIFIERS
Active ingredient group (AIG) number: 0132111001; AHFS:
CANCELLED POST MARKET
2018-01-02
- 1 - COPYRIGHT 1997, 2000, 2012 ASTRAZENECA CANADA INC. PRODUCT MONOGRAPH ACCOLATE ® (zafirlukast tablets) Leukotriene Receptor Antagonist AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.com Date of Revision: November 18, 2013 SUBMISSION CONTROL NO. 167197 ACCOLATE ® is a registered trademark of the AstraZeneca group of companies. - 2 - COPYRIGHT 1997, 2000, 2012 ASTRAZENECA CANADA INC. PRODUCT MONOGRAPH NAME OF DRUG ACCOLATE ® (zafirlukast tablets) Tablets 20 mg THERAPEUTIC CLASSIFICATION Leukotriene Receptor Antagonist ACTIONS AND CLINICAL PHARMACOLOGY Zafirlukast is a selective and competitive receptor antagonist of leukotriene D 4 and E 4 (LTD 4 and LTE 4 ). Cysteinyl leukotriene production and receptor occupation have been correlated with the pathophysiology of asthma, including airway edema, smooth muscle constriction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma. Patients with asthma were found in one study to be 25-100 times more sensitive to the bronchoconstricting activity of inhaled LTD 4 than nonasthmatic subjects. _In vitro_ studies demonstrated that zafirlukast antagonized the contractile activity of three leukotrienes (LTC 4 , LTD 4 and LTE 4 ) in conducting airway smooth muscle from laboratory animals and humans. Zafirlukast prevented intradermal LTD 4 -induced increases in cutaneous vascular permeability and inhibited inhaled LTD 4 -induced influx of eosinophils into animal lungs. Inhalational challenge studies in sensitized sheep showed that zafirlukast suppressed the airway responses to antigen; this included both the early- and late-phase response and the nonspecific hyperresponsiveness. In humans, zafirlukast inhibited bronchoconstriction caused by several kinds of inhalational challenges. Pretreatment with single oral doses of zafirlukast inhibited the bronchoconstriction caused by sulfur dioxide and cold air in patients with asthma. Pretreatment with single doses of קרא את המסמך השלם