Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: A. Menarini Industrie Farmaceutiche Riunite srl, Via Sette Santi 3, 50131 Firenze, Italy
Pharmacotherapeutic category: non-steroid anti-inflammatory drug for topical use
ATC code: MO2AA10
Ketoprofen, in a suitable excipient formulation, reaches the site of inflammation by transcutaneous route, allowing local treatment of painful affections of joints, tendons, ligaments and muscles.
Following oral administration of a single dose, maximum blood concentrations are reached within 2 hours.
Plasma half-life of ketoprofen varies from 1 hour to 3 hours; plasma protein binding is 60-90%. Elimination mainly occurs through the urinary rout and in the glycuronoconjugated form; approximately 90% of the administered dose is excreted within 24 hours.
Conversely the absorption by percutaneous route is very low. In fact, the application of 50-150 mg of ketoprofen by percutaneous route determines plasma levels of the active ingredient equal to 0.08-0.15 μg/mL about 5-8 hours after the application.
In animal trials no embryopathic effects have been found, while there is no epidemiological evidence of the safety of ketoprofen in human pregnancy. Pre-clinical and clinical studies on Fastum gel have not evidenced any serious side effects, although anecdotal cases of adverse reactions of systemic type have been described.
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