Floace ™

Fluorometholone Acetate Ophthalmic Suspension 0.1% w/v. Fluorometholone Acetate Ophthalmic Suspension 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

Trade Name:

Floace

Fluorometholone Acetate Ophthalmic Suspension 0.1% w/v

Composition:

Each ml contains :

Active Ingredient: Fluorometholone Acetate USP 1 mg

Auxiliary Matter:

Benzalkonium chloride, Sodium chloride, Monobasic sodium phosphate, Dibasic sodium phosphate, Disodium edetate, Hydroxyethyl Cellulose, Polysorbate 80, Hydrochloric acid and/or Sodium hydroxide (to adjust pH), Water for Injection.

Dosage Form:

Eye Drops

Flurometholone Acetate Ophthalmic Suspension 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

Dosage and method of Administration:

Shake well before use.

One to two drops instilled into the conjunctival sac(s) four times a day. During the initial 24 to 48 hours the dosage may be safely increased to two drops every two hours. If no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely.

Use in Special Populations:

Pregnancy: Pregnancy Category C. Flurometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed.

There are no adequate and well controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefits justifies the potential risk to the fetus.

Lactating women

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Flurometholone Acetate Ophthalmic Suspension 0.1% is administered to a nursing woman.

Paediatric Population:

Safety and effectiveness in pediatric patients have not been established.
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Carcinogenesis, Mutagenesis, Impairment of fertility:

No studies has been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

Contraindications:

Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; tuberculosis; fungal diseases; acute purulent untreated infections which, like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation

Warnings:

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION.

Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual acuity and visual field cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye masked or exacerbated by presence of steroid medication. In those diseases causing thinning of cornea or sclera, perforation has been known to occur with chronic use of topical steroids. It is advisable that the intraocular pressure be checked frequently.

Precautions:

Fungal infections of the cornea are particularly prone to develop coincidentally with long- term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.

The preservative in flurometholone acetate ophthalmic suspension, benzalkonium chloride may be absorbed by soft contact lens. Flurometholone acetate ophthalmic suspension should not be administered while wearing soft contact lens.

Undesirable Effects:

Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.

Pharmacological Properties:

Clinical Pharmacology

Corticosteroids suppress the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced. Clinical studies demonstrate that Flurometholone Acetate is significantly more efficacious than Fluorometholone for the treatment of external ocular inflammation.

Corticosteroids cause a rise in intraocular pressure in susceptible individuals. In a small study, Flurometholone Acetate Ophthalmic Suspension 0.1% demonstrated a significantly longer average time to produce a rise in intraocular pressure than did dexamethasone phosphate: however, the ultimate magnitude of the rise was equivalent for both drugs and in a small percentage of individuals a significant rise in intraocular pressure occurred within three days.

Shelf Life:

2 Years

Packaging Information:

Product is packed in a 5 ml white plastic bottle with a plastic nozzle pre sterilized and white plastic cap.

Storage and Handling Instructions:

Store at room temperature. Protect from light.

Marketed by: PROVIS

A division of Promed