Држава: Канада
Језик: Енглески
Извор: Health Canada
HYDROMORPHONE HYDROCHLORIDE
PURDUE PHARMA
N02AA03
HYDROMORPHONE
2MG
TABLET
HYDROMORPHONE HYDROCHLORIDE 2MG
ORAL
50
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0108698003; AHFS:
MARKETED
2005-04-01
PRODUCT MONOGRAPH N HYDROMORPH•IR ® HYDROMORPHONE HYDROCHLORIDE TABLETS 2, 4 AND 8 MG PURDUE PHARMA STD. OPIOID ANALGESIC ATC: N02AA03 Purdue Pharma 575 Granite Court Pickering, Ontario L1W 3W8 DATE OF REVISION: August 20, 2009 Control No.: 130742 Page 2 of 35 PRODUCT MONOGRAPH NAME OF DRUG N HYDROMORPH•IR ® Hydromorphone Hydrochloride Tablets 2, 4 and 8 mg THERAPEUTIC CLASSIFICATION Opioid Analgesic ACTIONS Hydromorphone, a semi-synthetic μ opioid agonist, is a hydrogenated ketone of morphine and shares the pharmacologic properties typical of opioid analgesics. Hydromorphone and related opioids produce their major effects on the central nervous system and gastrointestinal tract. These include analgesia, drowsiness, mental clouding, changes in mood, euphoria or dysphoria, respiratory depression, cough suppression, decreased gastrointestinal motility, nausea, vomiting, increased cerebrospinal fluid pressure, increased biliary pressure, pinpoint constriction of the pupils, increased parasympathetic activity and transient hyperglycemia. Estimates of the relative analgesic potency of parenterally administered hydromorphone to morphine in acute pain studies in man range from approximately 7:1 to 11:1. HYDROMORPH•IR ® (HYDROMORPHONE HYDROCHLORIDE TABLETS) PRODUCT MONOGRAPH Page 3 of 35 The relationship between plasma concentration of hydromorphone and analgesic effect has not been well established. In patients with chronic pain, hydromorphone should be titrated to the dose required to adequately relieve pain without unmanageable side effects. There is no intrinsic limit to the analgesic effect of hydromorphone; like morphine, adequate doses will relieve even the most severe pain. Clinically however, dosage limitations are imposed by the adverse effects, primarily respiratory depression, nausea and vomiting, which can result from high doses. PHARMACOKINETICS After oral administration of conventional release hydromorphone tablets, the drug is rapidly absorbed and, like morphine, undergoes pre-systemic eliminati Прочитајте комплетан документ