Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1   Pharmacodynamic properties
Pharmacotherapeutic group: Anti-inflammatory preparations, non-steroids for topical use.
ATC Code: M02AA15
Diclofenac hydroxyethylpyrrolidine or diclofenac epolamine is a water soluble salt of diclofenac.
Diclofenac is a nonsteroidal anti-inflammatory drug derived from phenylacetic acid which belongs to the aryl carboxylic acid group of compounds.
In the form of a medicated patch, it has topical anti-inflammatory and analgesic activity.

Pharmacokinetic Properties

5.2   Pharmacokinetic properties
Following cutaneous application of the medicated patch, diclofenac epolamine is absorbed through the skin.
The absorption kinetics at steady state show a prolonged release of the active ingredient with a maximum diclofenac plasma level (Cmax) of 17.4
±13.5ng/ml, which is reached after about 5 hours (Tmax 5.4±3.7 hours).
Diclofenac is extensively bound to plasma protein (about 99%).
Systemic transfer in healthy volunteers when using the medicated patch, compared with oral forms of diclofenac, is of the order of 2%, as estimated from the urinary excretion of the drug and its metabolites and from a between study comparison.