Loteprednol Etabonate 0.5% 5mL

NDC: 82260-299-05

Loteprednol Etabonate 0.5% Ophthalmic Suspension, 5 mL — Bausch & Lomb

Indications and Usage

Indicated for the treatment of steroid-responsive inflammatory conditions of the eye such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and selected infective conjunctivitis. Also indicated for treatment of postoperative inflammation following ocular surgery.

Dosage and Administration

Instill one to two drops into the conjunctival sac of the affected eye four times daily; during the initial week, dosing may be increased up to every hour if necessary. For postoperative inflammation, apply one to two drops four times daily beginning 24 hours after surgery and continuing through the first two weeks.

Warnings and Precautions

• Prolonged use may result in glaucoma, elevated intraocular pressure, optic nerve damage, and cataract formation
• May increase the risk of secondary ocular infections and delay healing, with possible corneal or scleral perforation
• Corticosteroids may prolong the course and worsen the severity of many viral, fungal, or bacterial eye infections
• Monitor intraocular pressure if the product is used for 10 days or longer

Contraindications

Contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis, vaccinia, and varicella, in mycobacterial and fungal diseases of ocular structures, and in patients with known hypersensitivity to any component.

Adverse Reactions

Common adverse reactions, occurring in 5 to 15% of patients, include blurred vision, burning on instillation, chemosis, discharge, dry eyes, itching, and foreign body sensation; elevated intraocular pressure and secondary infection may also occur.

Storage and Handling

Store upright at 15°C to 25°C (59°F to 77°F); do not freeze.

How Supplied

Supplied as a sterile suspension in a 5 mL plastic bottle with a controlled drop tip.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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