Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Ketoprofen is a non-steroidal anti-inflammatory drug. It has anti-inflammatory and analgesic actions.
Plasma and tissue levels of ketoprofen have been measured in 24 patients undergoing knee surgery. After repeated percutaneous administration of Oruvail gel the plasma levels were about 60 fold less (9-39 ng/g) than those obtained after a single oral dose of ketoprofen (490-3300 ng/g). Tissue levels at the area of application were within the same concentration range for the gel as for the oral treatment, although the gel was associated with a considerably higher inter-individual variability.
The bioavailability of ketoprofen after topical administration has been estimated to be approximately 5% of the level obtained after an orally administered dose, based on urinary excretion data.
The protein binding in plasma is approximately 99%. Ketoprofen is excreted through the kidneys mainly as glucuronide conjugate.
No additional pre-clinical data of relevance to the prescriber.
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