País: Canadá
Idioma: inglés
Fuente: Health Canada
MORPHINE SULFATE
ETHYPHARM INC
N02AA01
MORPHINE
200MG
CAPSULE (SUSTAINED-RELEASE)
MORPHINE SULFATE 200MG
ORAL
100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0104545013; AHFS:
APPROVED
2005-07-05
1 PRODUCT MONOGRAPH ZOMORPH ® (Morphine sulfate) 20, 40, 60, 120 and 200 mg Sustained-release Capsules Opioid Analgesic Ethypharm Inc., 200, boul. Armand-Frappier Laval, Quebec, H7V 4A6 Control # 101797 Date of Preparation: December 2005 Date of Revision: January 19, 2006 2 PRODUCT MONOGRAPH ZOMORPH ® (Morphine sulfate) 20, 40, 60, 120 and 200 mg Sustained-release Capsules OPIOID ANALGESIC ACTIONS AND CLINICAL PHARMACOLOGY Morphine is an opioid analgesic, which exerts an agonist effect at specific, saturable opioid receptors in the CNS and other tissues. In man, morphine produces a variety of effects including analgesia, constipation from decreased gastrointestinal motility, suppression of the cough reflex, respiratory depression from reduced responsiveness of the respiratory centre to CO 2 , nausea and vomiting via stimulation of the CTZ, changes in mood including euphoria and dysphoria, sedation, mental clouding, and alterations of the endocrine and autonomic nervous systems. The psychological effects are of longer duration than that of analgesia. Morphine-induced analgesia is relatively selective in that other sensory modalities (touch, vision, hearing) are not affected. Moderate doses of morphine are effective in relieving clinical (pathological) pain and increasing pain threshold to tolerate pain. The capacity of perceive the sensation of pain may be relatively unaltered. The analgesic effects of morphine are due to its CNS action, i.e, limbic system, hypothalamus, and centrally induced endocrinological effect. At present, the exact mechanism by which the opiates exert their effects remains unknown. Morphine is readily absorbed from the gastrointestinal tract and after s.c. or i.m. injection. Due to first-pass metabolism in the liver, the effect of an oral dose is less than after parenteral administration. With repeated regular dosing, orally administered morphine is about one-third as potent as when given by i.m. injection. Morphine is primarily excreted in the urine as morphine-3-glucuronide. About 7 to Leer el documento completo