Loteprednol Etabonate Ophthalmic Gel 0.5%, 5g

NDC: 82260-508-01

Loteprednol Etabonate Ophthalmic Gel 0.5%, 5 g, Lotemax Gel AG — Bausch & Lomb

Active ingredients	Loteprednol etabonate 0.5% (5 mg/g)
Dosage form	Ophthalmic gel
Route	Topical ophthalmic
Size	5 g
Manufacturer	Bausch & Lomb
NDC	82260-508-01

Indications and Usage

Indicated for the treatment of postoperative inflammation and pain following ocular surgery.

Dosage and Administration

Invert closed bottle and shake once to fill tip before instilling drops. Apply one to two drops into the conjunctival sac of the affected eye four times daily, beginning the day after surgery and continuing throughout the first two weeks of the postoperative period.

Warnings and Precautions

• Prolonged use may result in glaucoma, elevated intraocular pressure, optic nerve damage, and cataract formation; monitor intraocular pressure if used for 10 days or longer
• 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
• Patients should not wear contact lenses during treatment

Contraindications

Contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis, vaccinia, and varicella, in mycobacterial infection of the eye, and in fungal diseases of ocular structures.

Adverse Reactions

The most common adverse reactions (2 to 5%) are anterior chamber inflammation, eye pain, 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).

How Supplied

Supplied as a sterile ophthalmic gel in a 5 g 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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