Ocufen®

Flurbiprofen sodium 0.03% w/v

Eye drops.

Ocufen is indicated for

1) the inhibition of intraoperative miosis. Ocufen does not have intrinsic mydriatic properties and does not replace mydriatic agents.

2) the management of post-operative and post-laser trabeculoplasty inflammation in the anterior segment of the eye in patients in whom steroid therapy is not recommended.

Adult dosage: For the inhibition of intraoperative miosis, 1 drop is instilled every half hour starting 2 hours before surgery. The final drop should be given not less than 30 minutes before surgery.

To control post-operative and post-laser trabeculoplasty inflammation the dosing regimen above should be followed. Beginning twenty-four hours after surgery, one drop is administered four times daily for at least one week after laser trabeculoplasty or for two to three weeks after other surgery.

In accordance with standard practice, other topical medication should not be co-administered with Ocufen. When administering other topical medications, a minimum interval of 5 minutes between instillations is recommended.

Use in children: Safety and effectiveness in children have not been established.

Administration: Topical by instillation into the conjunctival sac.

Ocufen is contra-indicated in epithelial herpes simplex keratitis (dendritic keratitis) and in individuals hypersensitive to any component of the medication.

The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Ocufen is contra-indicated in individuals who have previously exhibited sensitivities to these drugs.

Use of Ocufen is contra-indicated in patients with known haemostatic defects or who are receiving other medications which may prolong bleeding time. Ocufen is contra- indicated for intraocular use during surgical procedures.

Wound healing may be delayed with the use of Ocufen.

There have been reports that Ocufen may cause an increased bleeding tendency of ocular tissues in conjunction with surgery.

Patients with a history of herpes simplex keratitis should be monitored closely.

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in some surgical patients treated with Ocufen.

Use in pregnancy: Safety of use in pregnant women has not been established. Ocufen should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

None known.

The most frequent adverse reactions reported with the use of Ocufen are transient burning and stinging on instillation, and other minor signs of ocular irritation.

No adverse effects are likely to be experienced following overdosage.

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.

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

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

Liquifilm® (polyvinyl alcohol)

Potassium chloride

Sodium chloride

Sodium citrate dihydrate

Citric acid monohydrate

Sodium hydroxide or

Hydrochloric acid (to adjust pH)

Purified water

None known.

The shelf life is 24 months for the unopened vial. The vial should be discarded after a single dose.

Store at or below 25^oC.

Clear, plastic unit dose vial, each containing 0.4 ml of solution.

Each vial of Ocufen should be used for a single dose and discarded after use.

Allergan Limited

Marlow International

The Parkway

Marlow

Buckinghamshire SL7 1YL

United Kingdom

PL 00426/0069

28^th June 1991/17^th May 2005

24^th November 2006