loteprednol etabonate

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%. Loteprednol etabonate ophthalmic suspension should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate ophthalmic suspension is also indicated for the treatment of post-operative inflammation following ocular surgery.

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). Post-Operative Inflammation: Apply one to two drops of loteprednol etabonate ophthalmic suspension into the conjunctival sac of the operated eye(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

CONTRAINDICATIONS Loteprednol Etabonate Ophthalmic Suspension, 0.2%, 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. Loteprednol Etabonate Ophthalmic Suspension, 0.2% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

ADVERSE REACTIONS Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2-0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis. Some of these events were similar to the underlying ocular disease being studied. Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis and pharyngitis. In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo. Among the smaller group of patients who were studied with Loteprednol Etabonate Ophthalmic Suspension, 0.2%, the incidence of clinically significant increases in IOP (≥10 mm Hg) was 1% (1/133) with Loteprednol Etabonate Ophthalmic Suspension, 0.2% and 1% (1/135) with placebo. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Information for Patients Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If pain develops, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses when using loteprednol etabonate ophthalmic suspension.

DESCRIPTION Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a micronized sterile white to off-white crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Loteprednol etabonate is represented by the following structural formula: Molecular formula: C 24 H 31 ClO 7 Molecular weight: 466.95 g/mol Chemical name: Chloromethyl 11β, 17-dihydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate, 17-(ethyl carbonate). Each mL of Loteprednol etabonate ophthalmic suspension, 0.2% contains: ACTIVE: Loteprednol etabonate, 2 mg (0.2%) PRESERVATIVE ADDED: Benzalkonium chloride, 0.01% INACTIVES: Edetate disodium, glycerin, povidone K 90, tyloxapol and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH between 5.3 to 5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. 1

HOW SUPPLIED Loteprednol Etabonate Ophthalmic Suspension, 0.5% is a sterile, white to off-white uniform suspension essentially free from foreign particles filled in 10 mL or 15 mL low density polyethylene white opaque bottle with low density polyethylene white opaque nozzle and high density polyethylene pink cap. It is available as follows: 5 mL in 10 mL Bottle (Filled to 1/2 Capacity): NDC 60219-1362-1 10 mL in 15 mL Bottle (Filled to 2/3 Capacity): NDC 60219-1362-2 15 mL in 15 mL Bottle: NDC 60219-1362-3 Storage: Store upright between 15° to 25°C (59° to 77°F). DO NOT FREEZE. KEEP OUT OF THE REACH OF CHILDREN. Rx only Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2025 Version-00 2