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

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.

Posology and method of administration

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.

Overdose

Overdose by the topical ophthalmic route will not ordinarily cause acute problems. If accidentally ingested, treatment should be symptomatic.

Shelf life

The shelf life is 24 months for the unopened vial. The vial should be discarded after a single dose. The remaining vials should be placed back in the original pouch after each use.

Special precautions for storage

Store at or below 25°C.

Nature and contents of container

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

Special precautions for disposal and other handling

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

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