Oral hydromorphone in extended-release form by ProQuest


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                  New drug information from the publishers of MPR

Oral hydromorphone in                                                  adequate pain control was
                                                                       achieved with once-daily dos-
                                                                                                            Increased intracranial pressure.
                                                                                                            Acute abdomen. GI surgery.
extended-release form                                                  ing, patients entered a 12-week,
                                                                       placebo-controlled treatment
                                                                                                            Impaired renal, hepatic, thy-
                                                                                                            roid, adrenocortical, or pul-
Product: Exalgo                   opioid-tolerant patients; that       phase. In this phase, patients       monary function. Gallbladder
Company: Mallinckrodt             is, patients who have been           were randomized to receive           disease. Biliary disease or
Pharmacologic class:              taking significant doses of           either the same dose of Exalgo,      surgery. Convulsive disorders.
Opioid analgesic                  opioids (e.g., oral morphine         or Exalgo and matched pla-           Delirium tremens.Toxic
Active ingredient:                60 mg/day, transdermal fen-          cebo in doses tapering from          psychosis. Circulatory shock.
Hydromorphone 8 mg, 12            tanyl 25 µg/hour, oxycodone          the stable dose achieved dur-        Drug abusers.Avoid abrupt
mg, 16 mg; extended-release       30 mg/day, oral hydro-               ing the titration phase (rescue      cessation. Elderly. Debilitated.
tablets; contains sulfites.        morphone 8 mg/day, oral              doses of an immediate-relief         Obstetric analgesia, labor and
Indication: Moderate-to-          oxymorphone 25 mg/day)               product allowed). Compared           delivery, nursing mothers: not
severe pain when continuous       for at least one week.After a        to placebo, Exalgo provided          recommended. Pregnancy
opioid analgesia is needed        single oral dose, plasma levels      superior analgesia. In average       (Cat. C).
for an extended time period.      gradually increase over six to       weekly pain intensity Numeric        Interactions: Not recom-
Not for as-needed use or to       eight hours.After that, the          Rating Scale scores, there was       mended within 14 days
treat acute or post-op pain.      concentration is sustained for       a significant difference in the       of monoamine oxidase
For use in opioid-tolerant        24 hours. Steady-state levels        mean changes from baseline to        inhibitors. Potentiation with
patients only.                    are reached
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