Version May 2024
Note: The acetate suspension demonstrates greater bioavailability than the sodium phosphate solution. Previous studies have demonstrated that generic prednisolone acetate may in some cases have reduced bioavailability due to manufacturing processes. Clinicians may wish to change to the brand prednisolone acetate in patients who do not respond to the generic formulation (Ref).
Corneal injury/ophthalmic inflammatory conditions: Ophthalmic:
Prednisolone acetate: Instill 1 to 2 drops in the affected eye(s) 2 to 4 times daily. If signs and symptoms fail to improve after 2 days, re-evaluate. Do not discontinue therapy prematurely; withdraw therapy with gradual tapering of dose in chronic conditions.
Prednisolone sodium phosphate: Instill 1 to 2 drops into conjunctival sac every hour during the day and every 2 hours at night until satisfactory response is obtained, then use 1 drop every 4 hours; subsequent reduction to 1 drop 3 to 4 times daily may be adequate. Do not discontinue therapy prematurely; withdraw therapy with gradual tapering of dose in chronic conditions.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Prednisolone (ophthalmic): Pediatric drug information")
Dosage guidance:
Dosage form information: Studies suggest that generic prednisolone acetate may, in some cases, have reduced bioavailability due to manufacturing processes. Clinicians may wish to change to brand prednisolone acetate in patients who do not respond to the generic formulation (Ref).
Ophthalmic inflammation, treatment: Infants, Children, and Adolescents:
Prednisolone acetate 0.12% (PredMild) or 1% (PredForte) suspension: Ophthalmic: Instill 1 to 2 drops into conjunctival sac of affected eye(s) 2 to 4 times daily; dosing frequency may be increased as necessary within the first 24 to 48 hours as clinically indicated.
There are no dosage adjustments provided in manufacturer's labeling.
There are no dosage adjustments provided in manufacturer's labeling.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Frequency not defined:
Ophthalmic: Glaucoma, increased intraocular pressure, optic nerve damage, secondary ocular infection, subcapsular posterior cataract
Miscellaneous: Wound healing impairment
Postmarketing:
Dermatologic: Pruritus, skin rash, urticaria
Gastrointestinal: Dysgeusia
Hypersensitivity: Hypersensitivity reaction
Nervous system: Headache
Ophthalmic: Blurred vision, eye irritation, eye pain, foreign body sensation of eye, transient burning or stinging in the eyes, visual disturbance
Hypersensitivity to prednisolone, any component of the formulation, or other corticosteroids; untreated ocular infection (bacterial, viral, varicella, fungal, mycobacteria); use after uncomplicated removal of a superficial corneal foreign body.
Concerns related to adverse effects:
• Cataracts: Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. Use following cataract surgery may delay healing or increase the incidence of bleb formation.
• Corneal thinning: Various ophthalmic disorders, as well as prolonged use of corticosteroids, may result in corneal and scleral thinning. Continued use in a patient with thinning may result in perforation.
• Glaucoma: Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) and/or glaucoma; damage to the optic nerve; and defects in visual acuity and fields of vision. Use with caution in patients with glaucoma; monitor IOP in any patient receiving treatment for ≥10 days.
• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), or prolong or exacerbate viral infections. Corticosteroids should not be used to treat ocular herpes simplex; use extreme caution in patients with a history of ocular herpes simplex; frequent slit lamp microscopy examinations are recommended. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.
• Systemic absorption: Studies have demonstrated topical ophthalmic corticosteroids are absorbed systemically and may cause endogenous corticosteroid production reduction. Caution is advised with prolonged use of topical ophthalmic corticosteroids in terms of systemic immunosuppression and additional systemic hazard of corticosteroid exposure (Burch 1968).
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
• Sulfite: May contain sodium bisulfite, which may cause allergic reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible individuals. The overall prevalence of sulfite sensitivity in the general population is unknown; however, sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people (Vally 2012).
Special populations:
• Contact lens wearers: Some formulations may contain benzalkonium chloride, which may be adsorbed by soft contact lenses; remove contacts prior to administration and wait 15 minutes before reinserting.
Other warnings/precautions:
• Appropriate use: For ophthalmic use only; patients should be re-evaluated if symptoms fail to improve after 2 days. Initial prescription and renewal of medication should be made only after examination with the aid of magnification such as slit lamp biomicroscopy or fluorescein staining (if appropriate). Not effective in Sjögren keratoconjunctivitis or mustard gas keratitis.
• Discontinuation of therapy: In chronic conditions, withdraw therapy with gradual tapering of dose.
Increased intraocular pressure (IOP) may occur, especially with prolonged use; in children, increased IOP has been shown to be dose dependent and produce a greater IOP in children <6 years than in older children (Lam 2005).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic, as sodium phosphate:
Generic: 1% (10 mL)
Suspension, Ophthalmic, as acetate:
Pred Forte: 1% (5 mL, 10 mL, 15 mL) [contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80, sodium bisulfite]
Pred Mild: 0.12% (5 mL, 10 mL)
Generic: 1% (5 mL, 10 mL, 15 mL)
Yes
Solution (prednisoLONE Sodium Phosphate Ophthalmic)
1% (per mL): $6.33
Suspension (Pred Forte Ophthalmic)
1% (per mL): $38.50
Suspension (Pred Mild Ophthalmic)
0.12% (per mL): $38.50
Suspension (prednisoLONE Acetate Ophthalmic)
1% (per mL): $10.56 - $11.05
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic:
Generic: 0.5% (0.5 mL)
Suspension, Ophthalmic, as acetate:
Pred Forte: 1% (5 mL, 10 mL) [contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80, sodium bisulfite]
Pred Mild: 0.12% ([DSC]) [contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80, sodium bisulfite]
Generic: 1% (5 mL, 10 mL)
For topical ophthalmic use only; to avoid eye injury or contamination, do not touch dropper tip to eyelids or other surfaces when placing drops in eyes. Apply finger pressure to lacrimal sac during and for 1 to 2 minutes after instillation to decrease risk of absorption and systemic effects. Shake suspension well before use.
Ophthalmic: For topical ophthalmic use only. Not for injection into eye. Shake suspension well before use; avoid contact of container tip with skin or eye to avoid eye injury or contamination. Wait at least 15 minutes after instilling solution before inserting soft contact lenses.
Corneal injury: Treatment of acute chemical injury of the cornea.
Ophthalmic inflammatory conditions: Treatment of ocular, anterior segment inflammation that is expected to be responsive to topical corticosteroid therapy.
0.12%: Treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera.
1%: Treatment of steroid-responsive, ocular inflammatory conditions.
PrednisoLONE may be confused with predniSONE
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy
Adverse events have been observed in animal reproduction studies. Prednisolone crosses the placenta when administered systemically; the amount of prednisolone available systemically following ophthalmic use is unknown. Refer to the Prednisolone (Systemic) monograph for additional information.
Prednisolone is present in breast milk when administered systemically; the amount of prednisolone available systemically following ophthalmic use is unknown. Due to the potential for serious adverse reactions in the breastfeeding infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or the drug, taking into account the importance of treatment to the mother. Refer to the Prednisolone (Systemic) monograph for additional information.
Monitor IOP in any patient receiving treatment for ≥10 days.
Reduces inflammation by inhibiting edema, leukocyte migration, fibrin deposition, capillary proliferation and dilation, collagen deposition and scar formation.
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