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Basic Drug Info
Drug Name:PREDNISOLONE SODIUM PHOSPHATE
Manufacturer:Bausch & Lomb Incorporated
Other Info:Bausch & Lomb IncorporatedTampa, FL 33637©Bausch & Lomb IncorporatedXO50176 (Folded)XM10030 (Flat)R.12/03-63



Clinical Trials:


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.
Corneal Diseases -- Diseases of the cornea.

Allergic Conjunctivitis -- Conjunctivitis due to hypersensitivity to various allergens.

rosacea -- A cutaneous disorder primarily of convexities of the central part of the FACE, such as FOREHEAD; CHEEK; NOSE; and CHIN. It is characterized by FLUSHING; ERYTHEMA; EDEMA; RHINOPHYMA; papules; and ocular symptoms. It may occur at any age but typically after age 30. There are various subtypes of rosacea: erythematotelangiectatic, papulopustular, phymatous, and ocular (National Rosacea Society's Expert Committee on the Classification and Staging of Rosacea, J Am Acad Dermatol 2002; 46:584-7).

Punctate epithelial keratoconjunctivitis --

Herpes zoster keratitis --

Herpes zoster keratoconjunctivitis --

Iritis -- Inflammation of the iris characterized by circumcorneal injection, aqueous flare, keratotic precipitates, and constricted and sluggish pupil along with discoloration of the iris.

Cyclitis -- Inflammation of the ciliary body.

Infective conjunctivitis --

Edema -- Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.

Inflammation -- A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.

Disorder of eye -- impairment of health or a condition of abnormal functioning of the organ of sight.

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.
Mycoses -- disease caused by a fungus.

acute disease/disorder -- Disease having a short and relatively severe course.

Vaccinia -- The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.

Chickenpox -- A highly contagious infectious disease caused by the varicella-zoster virus (HERPESVIRUS 3, HUMAN). It usually affects children, is spread by direct contact or respiratory route via droplet nuclei, and is characterized by the appearance on the skin and mucous membranes of successive crops of typical pruritic vesicular lesions that are easily broken and become scabbed. Chickenpox is relatively benign in children, but may be complicated by pneumonia and encephalitis in adults. (From Dorland, 27th ed)

Virus Diseases -- A general term for diseases produced by viruses.

Corneal Diseases -- Diseases of the cornea.

Tuberculosis -- Any of the infectious diseases of man and other animals caused by species of MYCOBACTERIUM.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

NOT FOR INJECTION INTO EYE - FOR TOPICAL USE ONLYEmployment 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.
Branded Drugs
The following US Branded drugs contain PREDNISOLONE SODIUM PHOSPHATE


NEO-HYDELTRASOL -- MERCK AND CO INC

HYDELTRASOL -- MERCK AND CO INC

INFLAMASE FORTE -- NOVARTIS PHARMACEUTICALS CORP

INFLAMASE MILD -- NOVARTIS PHARMACEUTICALS CORP

METRETON -- SCHERING CORP SUB SCHERING PLOUGH CORP

PREDAIR -- PHARMAFAIR INC

PREDAIR FORTE -- PHARMAFAIR INC

ORAPRED -- ASCENT PEDIATRICS INC

PEDIAPRED -- UCB INC

ORAPRED ODT -- MEDICIS PHARMACEUTICAL CORP

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE -- ALCON INC

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE -- BAUSCH AND LOMB PHARMACEUTICALS INC

SULSTER -- AKORN INC

VASOCIDIN -- NOVARTIS PHARMACEUTICALS CORP


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