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PrednisoLONE (Ophthalmic)

Pronunciation

(pred NISS oh lone)

Index Terms

  • Econopred
  • Prednisolone Acetate, Ophthalmic
  • Prednisolone Sod Phosphate
  • Prednisolone Sodium Phosphate, Ophthalmic

Dosage Forms

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:

Omnipred: 1% (5 mL, 10 mL) [contains benzalkonium chloride, edetate disodium, polysorbate 80]

Pred Forte: 1% (1 mL, 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)

Brand Names: U.S.

  • Omnipred
  • Pred Forte
  • Pred Mild

Pharmacologic Category

  • Corticosteroid, Ophthalmic

Pharmacology

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 corneal injury from chemical or thermal burns (excluding Pred Forte) or radiation burns or penetration of foreign bodies (Omnipred only).

Ophthalmic inflammatory conditions:

0.12%: Treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera.

1%: Treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as acne rosacea, allergic conjunctivitis, cyclitis, herpes zoster keratitis, iritis, superficial punctate keratitis, and selected infective conjunctivitis.

Contraindications

Hypersensitivity to prednisolone, any component of the formulation, or other corticosteroids; acute untreated purulent ocular infections; viral diseases of the cornea and conjunctiva (eg, epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella); mycobacterial infection of the eye; fungal diseases of ocular structures; use after uncomplicated removal of a superficial corneal foreign body (prednisolone sodium phosphate solution only)

Dosing: Adult

Ophthalmic inflammatory conditions/corneal injury: Ophthalmic:

Prednisolone acetate: Instill 1 to 2 drops in the affected eye(s) 2 to 4 times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. 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: Children and Adolescents (off-label use): Ophthalmic: Prednisolone acetate 1%: Limited data available: 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).

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

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).

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

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

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

Adverse Reactions

Frequency not defined.

Infection: Secondary ocular infection

Ophthalmic: Accommodation disturbance, blepharoptosis, conjunctival hyperemia, conjunctivitis, corneal ulcer, glaucoma, increased intraocular pressure, keratitis, optic nerve damage, mydriasis, subcapsular posterior cataract

Miscellaneous: Wound healing impairment

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 ≥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. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.

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 in susceptible individuals.

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 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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience change in taste, foreign body sensation in eye, headache, burning, or stinging. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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