OCUFEN Eye drops, solution Ref.[8116] Active ingredients: Flurbiprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory agents, non-steroids
ATC code: S01BC04

Flurbiprofen sodium is a non steroidal anti inflammatory agent which inhibits prostaglandin synthesis by inhibition of the cyclo-oxygenase enzyme.

Ophthalmic surgery causes prostaglandin release, with the effect that prostaglandin-mediated miosis may occur.

Treatment with Ocufen prior to surgery has been shown to inhibit intra-operative miosis and it is believed that this is brought about by inhibition of ocular prostaglandin release.

The sympathetic nervous system is not affected by this mechanism and acetylcholine- induced miosis has not been found to be inhibited in clinical trials.

Prostaglandins have also been shown to be mediators of certain kinds of intraocular inflammatory processes. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humour barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.

Pharmacokinetic properties

Flurbiprofen concentrations of 213 ng/ml in aqueous humour have been reported following half hourly treatment for two hours preceding surgery.

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in the Summary of Product Characteristics.

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