Overdose by the topical ophthalmic route will not ordinarily cause acute problems. If accidentally ingested, treatment should be symptomatic.
Hypersensitivity to the active substance or to any of the excipients.
Ocufen is contra-indicated in epithelial herpes simplex keratitis (dendritic keratitis).
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.
With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thromobocyte aggregation. The 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.
As with all Non-Steroidal Anti inflammatory drugs, Ocufen is contraindicated in the third trimester of pregnancy.
Not applicable
The following adverse reactions were reported during the use of Ocufen in clinical studies.
Very Common (> 1/10); Common (>1/100 to <1/10); Uncommon (>1/1,000 to <1/100); Rare (>1/10,000 to <1/1,000); Very Rare (<1/10,000) adverse reactions are presented according to MedDRA System organ class
Eye disorders:
Very common: Eye irritation, eye pain, Hyphema*
Additionally, the following adverse reactions have been identified during post marketing experience;
Eye disorders:
Not known: eye haemorrhage*, mydriasis (prolonged mydriasis), ocular hyperaemia.
* see section 4.4 for further information.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
There are no preclinical data of relevance to the prescriber which are additional to that already included in the Summary of Product Characteristics.
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.
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.
Flurbiprofen concentrations of 213 ng/ml in aqueous humour have been reported following half hourly treatment for two hours preceding surgery.
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.
Transient blurred vision can result after instillation. If this occurs, the patient should wait until the vision clears before driving or using machinery.
Posology:
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.
Paediatric population:
The safety and efficacy of Ocufen in children has not been established.
Elderly population:
There is no specific advice for the elderly.
Method of administration:
Ocufen is administered topically by instillation into the conjunctival sac.
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.
Each vial of Ocufen should be used for a single dose and discarded after use.
