Prescription Drugs

CLINICAL PHARMACOLOGY HMS® (medrysone) is a synthetic corticosteroid with topical anti-inflammatory and anti-allergic activity. Corticosteroids inhibit the inflammatory response to inciting agents of mechanical, chemical, or immunological nature of edema, fibrin deposition, capillary dilation and leukocyte migration, capillary proliferation, deposition of collagen and scar formation. HMS® (medrysone) has less anti-inflammatory potency than 0.1% dexamethasone. Data from 2 uncontrolled studies 1-2 indicate that in patients with increased intraocular pressure and in those susceptible to a rise in intraocular pressure, there is less effect on pressure with HMS® (medrysone 1% liquifilm opthalmic) than with dexamethasone or betamethasone.

DESCRIPTION HMS® (medrysone) 1.0% LIQUIFILM® sterile ophthalmic suspension is a topical anti-inflammatory agent for ophthalmic use. Chemical Name: (medrysone 1% liquifilm opthalmic) 11(beta)-Hydroxy-6(alpha)-methylpregn-4-ene-3, 20-dione. Contains: Active: medrysone 1.0%. Preservative: benzalkonium chloride 0.004%. Inactives: LIQUIFILM® (polyvinyl alcohol) 1.4%. edetate disodium; sodium chloride; potassium chloride; sodium phosphate, monobasic; sodium phosphate, dibasic; hydroxypropyl methylcellulose; sodium hydroxide to adjust the pH; and purified water.

PATIENT INFORMATION No Informatuion Provided.

OVERDOSE Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute. CONTRAINDICATIONS HMS® (medrysone) is contraindicated in the following conditions: Acute superficial herpes simplex Viral diseases of the conjunctiva and cornea Ocular tuberculosis Fungal diseases of the eye Hypersensitivity to any of the components of the drug

SIDE EFFECTS Adverse reactions include occasional transient stinging and burning on instillation. Increased intraocular pressure, which may be associated with optic nerve damage and defects in the visual fields, and posterior subcapsular cataract formation have been reported rarely with the use of HMS® (medrysone 1% liquifilm opthalmic) . DRUG INTERACTIONS No Informatuion Provided.

WARNINGS Acute purulent infections of the eye may be masked, enhanced or activated by the presence of corticosteroid medication. Corneal or scleral perforation occasionally has been reported with prolonged use of topical corticosteroids. In high dosages, they have been associated with corneal thinning. Prolonged use of topical corticosteroids may increase intraocular pressure, with resultant glaucoma, damage to the optic nerve, and defects in visual acuity and fields of vision. However, data from 2 uncontrolled studies 1-2 indicate that in patients with increased intraocular pressure and in those susceptible to a rise in intraocular pressure upon application of topical corticosteroids, there is less effect on pressure with HMS® (medrysone 1% liquifilm opthalmic) than with dexamethasone or betamethasone. Prolonged use of topical corticosteroids may rarely be associated with development of posterior subcapsular cataracts. Systemic absorption and systemic side effects may result with the use of topical corticosteroids. HMS® (medrysone 1% liquifilm opthalmic) is not recommended for use in iritis and uveitis as its therapeutic effectiveness has not been demonstrated in these conditions. Corticosteroid medication in the presence of stromal herpes simplex requires great caution; frequent slit-lamp microscopy is suggested. Prolonged use may aid in the establishment of secondary ocular infections from fungi and viruses liberated from ocular tissue. PRECAUTIONS General: With prolonged use of HMS® (medrysone 1% liquifilm opthalmic) , the intraocular pressure and the lens should be examined periodically. In persistent corneal ulceration where a corticosteroid has been used, or is in use, fungal infection should be suspected. Carcinogenesis, mutagenesis, impairment of fertility: No studies have been conducted in animals or in humans to evaluate the potential of these effects. Pregnancy Category C: Medrysone has been shown to be embryocidal in rabbits when given in doses 10 and 30 times the human dose. Medrysone was ocularly applied to both eyes of pregnant rabbits 2 drops 4 times per day on day 6 through 18 of gestation. A significant increase in early resorptions was observed in the treated rabbits. There are no adequate or well-controlled studies in pregnant women. Medrysone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.