PREDNISOLONE SODIUM PHOSPHATE

INDICATIONS AND USAGE Prednisolone sodium phosphate ophthalmic solution, 1% or 1/8% is for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation, corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. Prednisolone sodium phosphate ophthalmic solution, 1%, is recommended for moderate to severe inflammations, particularly when unusually rapid control is desired. In stubborn cases of anterior segment eye disease, systemic adrenocortical hormone therapy may be required. When deeper ocular structures are involved, systemic therapy is necessary.

DOSAGE AND ADMINISTRATION Depending on the severity of inflammation, instill one or two drops of solution into the conjunctival sac up to every hour during the day and every two hours during the night as necessary as initial therapy. When a favorable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three to four times daily may suffice to control symptoms. The duration of treatment will vary with the type of lesion and may extend from a few days to several weeks, according to therapeutic response. Relapses, more common in chronic active lesions than in self-limited conditions, usually respond to retreatment.

WARNINGS NOT FOR INJECTION INTO EYE - FOR TOPICAL USE ONLY Employment of steroid medication in the treatment of herpes simplex keratitis involving the stroma requires great caution; frequent slit-lamp microscopy is mandatory. Prolonged use may result in elevated intraocular pressure and/or glaucoma, damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation, or may aid in the establishment of secondary ocular infections from pathogens liberated from ocular tissues. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical steroids. Acute purulent untreated infection of the eye may be masked or activity enhanced by presence of steroid medication. Viral, bacterial, and fungal infections of the cornea may be exacerbated by the application of steroids. This drug is not effective in mustard gas keratitis and Sjögren’s keratoconjuncitivitis. If irritation persists or develops, the patient should be advised to discontinue use and consult prescribing physician.

CONTRAINDICATIONS The use of this preparation is contraindicated in the presence of: 1. Acute superficial herpes simplex keratitis. 2. Fungal diseases of ocular structures. 3. Acute infectious stages of vaccinia, varicella and most other viral diseases of the cornea and conjunctiva. 4. Tuberculosis of the eye. 5. Hypersensitivity to a component of this medication. The use of this preparation is always contraindicated after uncomplicated removal of a superficial corneal foreign body.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prednisolone sodium phosphate is administered to a nursing woman.

ADVERSE REACTIONS Glaucoma with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infections from pathogens including herpes simplex and fungi, and perforation of the globe. Rarely, filtering blebs have been reported when topical steroids have been used following cataract surgery. Rarely, stinging, or burning may occur. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.