Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic, as sodium phosphate:
Generic: 1% (10 mL)
Suspension, Ophthalmic, as acetate:
Omnipred: 1% (5 mL [DSC], 10 mL [DSC]) [contains benzalkonium chloride, edetate disodium, polysorbate 80]
Pred Forte: 1% (1 mL [DSC], 5 mL, 10 mL, 15 mL) [contains benzalkonium chloride, edetate disodium, polysorbate 80, sodium bisulfite]
Pred Mild: 0.12% (5 mL, 10 mL)
Generic: 1% (5 mL, 10 mL, 15 mL)
Pharmacology
Mechanism of Action
Reduces inflammation by inhibiting edema, leukocyte migration, fibrin deposition, capillary proliferation and dilation, collagen deposition and scar formation.
Use: Labeled Indications
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.
Contraindications
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.
Dosage and Administration
Dosing: Adult
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 (Fiscella 1998; Roberts 2007).
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.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Ophthalmic inflammation, treatment: Limited data available: Children and Adolescents: Prednisolone acetate 1% (suspension): Instill 1 to 2 drops into conjunctival sac 3 to 6 times daily. If signs and symptoms fail to improve after 2 days, re-evaluate. Initiate with more frequent dosing, and decrease as clinically indicated. If signs and symptoms fail to improve after 2 days, re-evaluate (Wilson, 2009).
Administration
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.
Storage
Omnipred: Store at 8°C to 24°C (46°F to 75°F). Protect from freezing.
Pred Forte: Store up to 25°C (77°F). Protect from freezing.
Pred Mild: Store at 15°C to 30°C (59°F to 86°F). Protect from freezing.
Prednisolone sodium phosphate (solution): Store at 15°C to 25°C (59°F to 77°F). Protect from light.
Drug Interactions
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. Monitor therapy
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Adverse Reactions
Frequency not defined:
Infection: Secondary ocular infection
Ophthalmic: Glaucoma, increased intraocular pressure, optic nerve damage, subcapsular posterior cataract
Miscellaneous: Wound healing impairment
<1%, postmarketing, and/or case reports: Blurred vision, dysgeusia, eye irritation, eye pain, foreign body sensation of eye, headache, hypersensitivity reaction, pruritus, skin rash, transient burning or stinging in the eyes, urticaria, visual disturbance
Warnings/Precautions
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 ≥104 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.
Monitoring Parameters
Monitor IOP in any patient receiving treatment for ≥10 days.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
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.
Patient Education
What is this drug used for?
- It is used to treat eye swelling.
Frequently reported side effects of this drug
- Change in taste
- Foreign body sensation in eye
- Headache
- Burning
- Stinging
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Vision changes
- Eye pain
- Severe eye irritation
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
