Loteprednol Etabonate

Indications

INDICATIONS AND USAGE Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid- responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate ophthalmic suspension is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate ophthalmic suspension experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate ophthalmic suspension and 6% with prednisolone acetate 1%.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION SHAKE VIGOROUSLY BEFORE USING. Steroid-Responsive Disease Treatment: Apply one to two drops of loteprednol etabonate ophthalmic suspension into the conjunctival sac of the affected eye(s) four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS ).

Contraindications

CONTRAINDICATIONS Loteprednol etabonate as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Warnings and precautions

WARNINGS Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.

Storage and supply

HOW SUPPLIED Loteprednol etabonate ophthalmic suspension is supplied in an opaque white LDPE bottle with a controlled drop tip with cap in the following sizes: NDC 70748-300-01: 5 mL in a 7.5 mL bottle NDC 70748-300-02: 10 mL in a 10 mL bottle NDC 70748-300-03: 15 mL in a 15 mL bottle DO NOT USE IF NECKBAND IMPRINTED WITH "PROTECTIVE SEAL" IS NOT I…

Source: Loteprednol Etabonate (Loteprednol Etabonate) — US FDA prescribing information, 2026-02-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.