Land: Kanada
Tungumál: enska
Heimild: Health Canada
OXYCODONE HYDROCHLORIDE
PURDUE PHARMA
N02AA05
OXYCODONE
20MG
TABLET (EXTENDED-RELEASE)
OXYCODONE HYDROCHLORIDE 20MG
ORAL
50
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0107552001; AHFS:
CANCELLED POST MARKET
2012-09-26
_Page 1 of 49_ PRODUCT MONOGRAPH N OXYCONTIN ® OXYCODONE HYDROCHLORIDE CONTROLLED RELEASE TABLETS 5, 10, 15, 20, 30, 40, 60, 80, 120 AND 160 MG PURDUE PHARMA STD. OPIOID ANALGESIC Purdue Pharma 575 Granite Court Pickering, Ontario L1W 3W8 DATE OF REVISION: Control No.: 148343 November 8, 2011 ® Purdue Pharma, owner of the registered trademark OxyContin _Page 2 of 49_ PRODUCT MONOGRAPH NAME OF DRUG N OXYCONTIN ® Oxycodone Hydrochloride Controlled Release Tablets 5, 10, 15, 20, 30, 40, 60, 80, 120 and 160 mg Purdue Pharma Std. PHARMACOLOGICAL CLASSIFICATION Opioid Analgesic ACTIONS Oxycodone is a semi-synthetic opioid analgesic which exerts an agonist effect at specific, saturable opioid receptors in the CNS and other tissues. In man, oxycodone 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 center to CO 2 , nausea and vomiting via stimulation of the chemoreceptor trigger zone, changes in mood including euphoria and dysphoria, sedation, mental clouding, and alterations of the endocrine and autonomic nervous systems. PHARMACODYNAMICS Oxycodone retains at least one-half of its analgesic activity when administered orally and with acute dosing is approximately twice as potent as orally administered morphine. There is no intrinsic limit to the analgesic effect of oxycodone; like morphine, adequate doses will relieve even the most severe pain. Clinically, however, dosage limitations are imposed by OXYCONTIN ® (OXYCODONE HCL CR TABLETS) PRODUCT MONOGRAPH _Page 3 of 49_ the adverse effects, primarily respiratory depression, nausea and vomiting, which can result from high doses. Studies with OXYCONTIN ® (oxycodone hydrochloride controlled release tablets) and immediate release oxycodone hydrochloride tablets (Oxy•IR ® ) in normal volunteers and patients demonstrate a consistent relationship between oxycodone dosage and plasma oxycodone concentrations as well Lestu allt skjalið