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1. Name Of The Medicinal Product


2. Qualitative And Quantitative Composition

Flurbiprofen sodium 0.03% w/v

3. Pharmaceutical Form

Eye drops.

4. Clinical Particulars 4.1 Therapeutic Indications

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.

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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.

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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.

4.9 Overdose

No adverse effects are likely to be experienced following overdosage.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

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

5.3 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.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Liquifilm® (polyvinyl alcohol)

Potassium chloride

Sodium chloride

Sodium citrate dihydrate

Citric acid monohydrate

Sodium hydroxide or

Hydrochloric acid (to adjust pH)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

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

6.4 Special Precautions For Storage

Store at or below 25oC.

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

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

7. Marketing Authorisation Holder

Allergan Limited

Marlow International

The Parkway


Buckinghamshire SL7 1YL

United Kingdom

8. Marketing Authorisation Number(S)

PL 00426/0069

9. Date Of First Authorisation/Renewal Of The Authorisation

28th June 1991/17th May 2005

10. Date Of Revision Of The Text

24th November 2006


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