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Diclofenac sodium injection (Dyloject): in postoperative pain.

Abstract
*A new formulation of the nonselective NSAID diclofenac sodium suitable for intravenous bolus injection has been developed using hydroxypropyl beta-cyclodextrin as a solubility enhancer (HPbetaCD diclofenac). * HPbetaCD diclofenac intravenous bolus injection was shown to be bioequivalent to the existing parenteral formulation of diclofenac containing propylene glycol and benzyl alcohol as solubilizers (PG-BA diclofenac), which is relatively insoluble and requires slow intravenous infusion over 30 minutes. * Single-dose HPbetaCD diclofenac 3.75, 9.4, 18.75, 25, 37.5, 50 and 75 mg administered by intravenous bolus injection produced significantly greater responses than placebo for total pain relief (TOTPAR) over 6 hours or pain intensity at 4 hours in the treatment of moderate or severe postoperative dental pain in randomized, double-blind trials. HPbetaCD diclofenac 37.5 and 75 mg were similar in efficacy to intravenous bolus ketorolac 30 mg. * In a well controlled trial, single-dose HPbetaCD diclofenac 75 mg intravenous bolus injection was shown to be superior to PG-BA diclofenac 75 mg intravenous infusion with respect to TOTPAR over 4 hours, indicating faster onset of analgesia in the treatment of moderate or severe postoperative dental pain. Both HPbetaCD diclofenac and PG-BA diclofenac were superior to placebo. * HPbetaCD diclofenac was generally well tolerated during single-dose treatment of postoperative pain. The tolerability profile was similar to that of PG-BA diclofenac, but with a lower incidence of thrombophlebitis.
AuthorsPaul L McCormack, Lesley J Scott
JournalDrugs (Drugs) Vol. 68 Issue 1 Pg. 123-30 ( 2008) ISSN: 0012-6667 [Print] New Zealand
PMID18081376 (Publication Type: Journal Article, Review)
Chemical References
  • Anti-Inflammatory Agents, Non-Steroidal
  • Diclofenac
Topics
  • Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects, economics, pharmacokinetics)
  • Diclofenac (administration & dosage, adverse effects, economics, pharmacokinetics)
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Costs
  • Humans
  • Injections, Intravenous
  • Pain Measurement
  • Pain, Postoperative (prevention & control)
  • Treatment Outcome

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