Clinical Drug Investigation

, Volume 27, Issue 3, pp 163–195 | Cite as

Diclofenac Potassium 12.5mg Tablets for Mild to Moderate Pain and Fever

A Review of Its Pharmacology, Clinical Efficacy and Safety
Review Article

Abstract

Non-prescription (over-the-counter [OTC]) analgesics are used for the short-term treatment of acute painful conditions of mild to moderate intensity in everyday life. Well documented safety and efficacy, a rapid onset of action and a flexible daily dosing regimen are essential in this context. Film-coated, immediate-release, low-dose diclofenac potassium, developed for OTC use, offers a flexible daily dosing regimen with an initial dose of two tablets (2 × 12.5mg) followed by one or two tablets up to a maximum daily dose of six tablets (75 mg/day). The maximum plasma drug concentration is reached 30 minutes after administration, and the mean terminal half-life is 1-2 hours, allowing a 4-to 6-hour duration of activity, depending on the condition.

Thirteen randomised, double-blind trials with both placebo and active controls have demonstrated the efficacy of diclofenac potassium 12.5mg tablets in conditions suitable for treatment with OTC medication, for example, acute lower back pain, headache, acute pain after dental extraction, symptoms of cold and influenza (including fever), and dysmenorrhoea. A single dose of diclofenac potassium 12.5mg is the lowest recommended effective dose. A two-tablet single dose of 25mg is at least as effective as ibuprofen 400mg. A flexible dosing regimen of an initial two tablets followed by one or two tablets up to a total daily dose of 75mg is as effective as ibuprofen used in comparable fashion up to a total daily dose of 1200mg.

The incidence of adverse events in patients taking single or multiple doses of diclofenac potassium is similar to that of ibuprofen and placebo. In a safety study conducted to compare diclofenac potassium with ibuprofen for up to 3 months in patients with osteoarthritis of the knee, no differences in the pattern of adverse events were noted. There was no evidence of either hepatic injury or cardiovascular safety-related issues at any time during the study.

Patients are generally capable of taking diclofenac potassium appropriately. A maximum OTC treatment duration of 5 days for pain and 3 days for fever is recommended.

Notes

Acknowledgements

The author would like to thank Novartis Consumer Health for providing the data used to prepare this review, and Drs Ackerman, Unkauf and Farrenkopf for their assistance in preparing the manuscript. The persons acknowledged here are employees of Novartis or were commissioned by Novartis to provide the data used in this review. The author received no funding in relation to the preparation, submission or acceptance of this paper. The author has no conflicts of interest that are directly relevant to the contents of this review.

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Copyright information

© Adis Data Information BV 2007

Authors and Affiliations

  1. 1.Department of PharmacologyUniversité Victor SegalenBordeauxFrance
  2. 2.CHU de BordeauxBordeauxFrance

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