Prednisolone (ophthalmic)

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# Overview
Prednisolone (ophthalmic) is a corticosteroid that is FDA approved 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, thermal burns and penetration of foreign bodies.   Common adverse reactions include glaucoma with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation and secondary ocular infections.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- 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.

### Dosing Information
- 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Prednisolone (ophthalmic) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Prednisolone (ophthalmic) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Prednisolone (ophthalmic) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Prednisolone (ophthalmic) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Prednisolone (ophthalmic) in pediatric patients.

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

# 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 Sjogrens keratoconjuncitivitis.
- If irritation persists or develops, the patient should be advised to discontinue use and consult prescribing physician.

### PRECAUTIONS
- As fungal infections of the cornea are particularly prone to develop coincidentally with long-term steroid applications, fungus invasion must be suspected in any persistent corneal ulceration where a steroid has been used or is in use.
- Intraocular pressure should be checked frequently.

# Adverse Reactions

## Clinical Trials Experience
- 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.

## Postmarketing Experience
There is limited information regarding Prednisolone (ophthalmic) Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Prednisolone (ophthalmic) Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- Animal reproductive studies have not been conducted with prednisolone sodium phosphate. It is also not known whether prednisolone sodium phosphate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Prednisolone sodium phosphate should be given to a pregnant woman only if clearly needed.
- The effect of prednisolone sodium phosphate on the later growth, development and functional maturation of the child is unknown.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Prednisolone (ophthalmic) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Prednisolone (ophthalmic) during labor and delivery.

### 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.

### Pediatric Use
There is no FDA guidance on the use of Prednisolone (ophthalmic) in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Prednisolone (ophthalmic) in geriatric settings.

### Gender
There is no FDA guidance on the use of Prednisolone (ophthalmic) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Prednisolone (ophthalmic) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Prednisolone (ophthalmic) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Prednisolone (ophthalmic) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Prednisolone (ophthalmic) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Prednisolone (ophthalmic) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Ophthalmology

### Monitoring
There is limited information regarding Prednisolone (ophthalmic) Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Prednisolone (ophthalmic) and IV administrations.

# Overdosage
There is limited information regarding Prednisolone (ophthalmic) overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action
- Prednisolone sodium phosphate causes inhibition of inflammatory response to inciting agents of mechanical, chemical, or immunological nature. No generally accepted explanation of this steroid property has been advanced.

## Structure
- Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, is a sterile solution for ophthalmic administration having the following composition:
- Each mL Contains:
- ACTIVE: Prednisolone Sodium Phosphate 10 mg (1%)  in a buffered isotonic solution containing INACTIVES: Hypromellose, Monobasic and Dibasic Sodium Phosphate, Sodium Chloride, Edetate Disodium and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust the pH (6.2 - 8.2).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
- The chemical name for prednisolone sodium phosphate is Pregna-1, 4-diene - 3, 20-dione, 11, 17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11 ) -, which has the following structural formula:

## Pharmacodynamics
There is limited information regarding Prednisolone (ophthalmic) Pharmacodynamics in the drug label.

## Pharmacokinetics
There is limited information regarding Prednisolone (ophthalmic) Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Prednisolone (ophthalmic) Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Prednisolone (ophthalmic) Clinical Studies in the drug label.

# How Supplied
Prednisolone Sodium Phosphate Ophthalmic Solution USP, 1% is supplied in a plastic squeeze bottle with a controlled drop tip in the following sizes:
5 mL bottle - NDC 24208-715-02
10 mL bottle - NDC 24208-715-10
15 mL bottle - NDC 24208-715-06
Revised: January 2013
Bausch & Lomb Incorporated 
Tampa, FL 33637
Bausch & Lomb Incorporated
9101403 (Folded) 
9101503 (Flat)

## Storage
- Store between 15 - 25 C (59 - 77 F).
- Protect from light. Keep tightly closed.
- DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.
- KEEP OUT OF REACH OF CHILDREN.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- Do not touch dropper tip to any surface as this may contaminate the solution.

# Precautions with Alcohol
Alcohol-Prednisolone (ophthalmic) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
There is limited information regarding Prednisolone (ophthalmic) Brand Names in the drug label.

# Look-Alike Drug Names
There is limited information regarding Prednisolone (ophthalmic) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price