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Feny (Ophthalmic Solution)

COMPOSITION

Each ml contains:
Flurbiprofen Sodium U.S.P …………..0.30mg.
With:  Thiomersal  0.005%, sodium chloride, sodium citrate, potassium chloride, edentate disodium, polyvinyl alcohol 14 mg and purified water.

CLINICAL PHARMACOLOGY

Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins.
Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure.Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, Flurbiprofen has been shown to inhibit the miosis induced during the course of cataract surgery.
Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure.

INDICATIONS

Feny is indicated for the inhibition of intraoperative miosis. It is also indicated for the treatment of inflammation of the anterior segment of the eye after cataract surgery, after laser trabeculoplasty, for the prevention of pseudophakic cystoid macular edema (CME) postoperatively and as an analgesic in relieving ocular pain associated with surgery.

CONTRAINDICATIONS

It is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis) and in individuals who are hypersensitive to any components of the medication.

ADVERSE EFFECTS

The most frequent adverse reactions reported with the use of Flurbiprofen are transient burning and stinging upon instillation and other minor symptoms of ocular irritation. It is known that some systemic absorption does occur with ocularly applied drug, and that nonsteroidal anti-inflammatory drugs have been shown to increase bleeding time by interference with thrombocyte aggregation.

There have been reports that ocularly applied Flurbiprofen may cause an increase bleeding tendency of ocular tissues in conjunction with surgery. It is recommended that Flurbiprofen be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

PRECAUTIONS

There exists the potential for cross sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drug. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drug.

Acute infections of the eye may be masked by the use of topical anti-inflammatory agents. Flurbiprofen possesses no inherent antimicrobial activity. Use of Flurbiprofen with an anti-infected drug in the presence of acular infections should be monitored closely.

Patients with histories of herpes simplex keratitis should be monitored closely. Wound healing may be delayed with the use of Flurbiprpfen.

DOSAGE

For Control of Intraoperetive Miosis: A total 4 to 6 drops of Feny should be administered by instilling one (1) drop in the eye approximately every half hour beginning 2 to 3 hours before surgery.

For Postoperative inflammation: To control postoperative inflammation after cataract or laser trabeculoplasty surgery, pretreatment dosing is recommended using either the dosing regimen listed above or by dosing every 15 minutes beginning 90 minutes before surgery for a total of  6 drops. Postoperatively, one drop should be instilled into the conjunctival sac every four hours for one week after laser trabeculoplasty and for 2 to 3 weeks after surgical procedures. Dosing can then be tapered according to clinical necessity.

For Prevention of CME: For the prevention of cystoid macular edema postoperatively, beginning two days prior to surgery, one (1) drop should be instilled four times a day. Beginning two hours before surgery, one (1) drop should be instilled every 30 minutes for a total of four drops. Postoperatively, one (1) drop should be instilled four times daily for three to six months.

For use as an analgesic: To relieve ocular pain associated with surgery, beginning one day prior to surgery one (1) drop should be instilled every four hour while awake. Beginning two hours before surgery, one (1) drop should be instilled every 20 minutes for a total of six drops. Postoperatively, one (1) drops should be instilled every four hours while awake for 2 weeks.

HOW SUPPLIED

Feny Ophthalmic solution is available as a sterile solution in 5 ml pilfer proof plastic dropper bottles (Gamma Irradiated)

STORAGE

Protect from sunlight. Keep away from children’s reach. Do not freeze. Store between 15˚ to 25˚ C.
After opening the bottle , use within 4 weeks.