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Erschienen in:
01.01.2008 | Adis Drug Profile
Diclofenac Sodium Injection (Dyloject®)
In Postoperative Pain
Erschienen in: Drugs | Ausgabe 1/2008
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▲ 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).
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▲ 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.
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▲ 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.
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▲ 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.
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▲ 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.