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Drugs

, Volume 68, Issue 1, pp 123–130 | Cite as

Diclofenac Sodium Injection (Dyloject®)

In Postoperative Pain
Adis Drug Profile

Abstract

  • ▲ A new formulation of the nonselective NSAID diclofenac sodium suitable for intravenous bolus injection has been developed using hydroxypropyl β-cyclodextrin as a solubility enhancer (HPβCD diclofenac).

  • ▲ HPβCD 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 HPβCD 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. HPβCD diclofenac 37.5 and 75 mg were similar in efficacy to intravenous bolus ketorolac 30 mg.

  • ▲ In a well controlled trial, single-dose HPβCD 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 HPβCD diclofenac and PG-BA diclofenac were superior to placebo.

  • ▲ HPβCD 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.

Keywords

Pain Intensity Ketorolac Thrombophlebitis Intramuscular Administration Intravenous Bolus Injection 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Adis Data Information BV 2008

Authors and Affiliations

  1. 1.Wolters Kluwer Health ¦ AdisMairangi Bay, North Shore 0754, AucklandNew Zealand
  2. 2.Wolters Kluwer HealthConshohockenUSA

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