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Eyfem (Ophthalmic Suspension & Ointment)

 

COMPOSITION

Eye Drops:
Each ml contains:
Fluorometholone U.S.P. ……………………. 1.0 mg.
with: Benzalkonium chloride 0.004%, sodium chloride, edetate disodium, polysorbate 80, polyvinyl alcohol 14 mg and purified water.
Ophthalmic Ointment:
Each gm contains:
Fluorometholone U.S.P. ……………………. 1.0 mg.
with: Mineral oil & white petrolatum.
DESCRIPTION: Fluorometholone (Eyfem) is a glucocorticoid employed as eye drops/ointment containing 0.1% in the treatment of allergic and inflammatory conditions of the eye.

CLINICAL PHARMACOLOGY

Fluorometholone has 40 times powerful anti-inflammatory action than hydrocortisone. Like all anti- inflammatory glucocorticoids, fluorometholone inhibits phospholipase A2, the first stage in prostaglandin synthesis. Fluorometholone also inhibits the chemotactic migration of neutrophilic cells into the focus of inflammation. In contrast to other topical glucocorticoids, fluorometholone has an anti-inflammatory action without significantly influencing the intraocular pressure. The immunosuppressive action of fluorometholone is less pronounced than that of dexamethasone. With a single administration of fluorometholone eye drops in the eye, maximum concentrations of 1.5 µg to 1.9 µg were measured in the cornea after 30 minutes. In comparison with other corticosteroids, fluorometholone is more rapidly degraded in the tissue and therefore, has less effect on the intraocular pressure.

INDICATIONS

Eyfem is indicated for the treatment of corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

CONTRAINDICATIONS

Vaccinia, varicella, acute superficial herpes simplex keratitis (dendritic keratitis), and many other viral diseases of the cornea and conjunctiva, tuberculosis of the eye, fungal diseases of the ocular structures, hypersensitivity to any component of the medication.

ADVERSE REACTIONS AND PRECAUTIONS

Steroids may mask, activate or enhance infection, if no improvement is observed after few days treatment, other measures should be followed.
- Prolonged topical corticosteroid therapy is a possible factor in the formation of posterior subcapsular cataract, or may help in occurrence of secondary eye infections from fungi or viruses.
- Topical steroids when used in diseases causing thinning of cornea or sclera may lead to perforation of the globe.
- Extended use of fluorometholone may cause an increase in IOP in certain cases, most of those with family history of glaucoma. However, it is to be noted that tendency to increase IOP is minimal with fluorometholone as compared with other corticosteroids.
Treatment should be continued with regular monitoring of IOP.
- Prolonged use of topical steroids may result in overgrowth of non-susceptible organisms including fungi.
- Corticosteroid medication requires great care while treating the patients with a history of herpes simplex keratitis.

Use in Children: Safety and effectiveness have not been demonstrated in children of the age group 2 years or below.

Use in Pregnancy: Safety of the use of topical steroids during pregnancy has not been established.

DOSAGE

Eye Drops:1 to 2 drops into the conjunctival sac(s) 2 to 4 times daily. During the initial 24 to 48 hours, the dosage may be safely increased to 2 drops every hour or as directed by the ophthalmologist.
Ophthalmic Ointment: Apply a small amount (app. 1/2 inch ribbon) into the conjunctival sac (s) one to three times daily. During the initial 24 to 48 hours, the frequency of dosing may be increased to one application every four hours.
Care should be taken not to discontinue therapy prematurely.

HOW SUPPLIED

Eyfem Eye Drops is available as a sterile suspension in 5 ml pilfer proof plastic dropper bottles (Gamma Irradiated).
Eyfem Ophthalmic Ointment is available as a sterile ointment in 5 gm ophthalmic tube (Gamma Irradiated).

STORAGE

Protect from sunlight. Keep away from children’s reach. Do not freeze. Store between 15°C to 30°C.
After opening the bottle/tube, use within 4 weeks.