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Eyfem-N (Ophthalmic Suspension)

COMPOSITION

Each ml contains:

Fluorometholone U.S.P. 1.0 mg. Neomycin Sulphate U.S.P. equivalent to Neomycin base 3.5mg. with: Benzalkonium chloride, sodium chloride, edetate disodium, polysorbate 80, polyvinyl alcohol 14 mg and purified water.

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.

Neomycin sulphate has got bactericidal activity against a wide range of Gram – ve bacteria such as, Escherichia coli, Heamophilus influenzae, Klebsiella, Enterobactor spp; Neisseria spp; and proteus vulgaris. Gram + ve bacteria that are inhibited include staphylococcus aureus and corynebacterium. It is useful in many eye infections especially when used in combination with a potent anti-inflammatory agent.

INDICATIONS

Eyfem-N is indicated for the treatment of infectious conjunctivitis due to organisms sensitive to neomycin.
It may be used for the treatment of anterior segment inflammatory disorders which may be threatened with or complicated by bacteria sensitive to neomycin. Eyfem-N is effective following removal of foreign bodies as well as before and after surgery where the possibility of infection with susceptible organisms exist.

CONTRAINDICATIONS

It is contraindicated in acute untreated purulent ocular infections caused by microorganisms not sensitive to neomycin. Acute superficial herpes simplex (dendritic keratitis), vaccinia, varicella and most other viral diseases of the conjunctiva and cornea. Ocular tuberculosis. Fungal diseases of the eyes. Hypersensitivity to any of the components of the drug.

ADVERSE REACTIONS AND PRECAUTIONS

Prolonged use may cause increased intraocular pressure in susceptible individuals resulting in glaucoma. Intraocular pressure should be routinely monitored. Posterior subcapsular cataract formation has been reported to occur after protracted use of topical corticosteroids. Prolonged use may suppress the host immune response in ocular tissues and thus increase the possibility of secondary ocular infections. When signs of chronic ocular inflammation persists following prolonged corticosteroid dosing, the possibility of fungal infections of the cornea should be considered. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection. Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

Use in children: Safety and effectiveness in children have not been established.

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

DOSAGE

1 drop into the conjunctival sac(s) 2 to 4 times daily. During the initial 24-48 hours, the dosage may be safely increased to 1 drop every hour or as directed by the ophthalmologist. Care should be taken not to discontinue therapy prematurely.

HOW SUPPLIED

Eyfem-N eye drops is available as a sterile suspension 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°C to 30°C.
After opening the bottle, use within 4 weeks.