ORUVAIL Controlled release capsule Ref.[7739] Active ingredients: Ketoprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  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

Pharmacodynamic properties

Ketoprofen overall has the properties of a potent non-steroidal anti-inflammatory agent.

It has the following pharmacological effects:

Anti-inflammatory:

It inhibits the development of carageenan-induced abscesses in rats at 1 mg/kg, UV radiation induced erythema in guinea pigs at 6 mg/kg. It is also a potent inhibitor of PGE2 and PFG2oc synthesis in guinea pig and human chopped lung preparations.

Analgesic:

Ketoprofen effectively reduced visceral pain in mice caused by phenyl benzoquinone or by bradykinin following p.o. Administration at about 6 mg/kg.

Antipyretic:

Ketoprofen (2 and 6 mg/kg) inhibited hyperthermia caused by s.c injection of brewer’s yeast in rats and, at 1 mg/kg hyperthermia caused by i.v. administration of anticoagulant vaccine to rabbits.

Ketoprofen at 10 mg/kg i.v. did not affect the cardiovascular, respiratory, central nervous system or autonomic nervous systems.

Pharmacokinetic properties

Ketoprofen is slowly but completely absorbed from Oruvail capsules. Maximum plasma concentration occurs after 6–8 hours. It declines thereafter with a half-life of about 8 hours. There is no accumulation on continued daily dosing. Ketoprofen is very highly bound to plasma protein.

Preclinical safety data

No additional data of relevance to the prescriber.

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