Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Loteprednol Etabonate Ophthalmic Suspension, 0.2% is supplied in a plastic bottle with a controlled drop tip in the following sizes: NDC 72485-653-05 5 ml in a 5 ml bottle NDC 72485-653-10 10 ml in a 10 ml bottle Storage: Store upright between 15° to 25°C (59° to 77°F). DO NOT FREEZE. DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Keep out of reach of children. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 USA Manufactured by: Ophtapham AG Riethofstrasse 1, Hettlingen, 8442, Switzerland (CHE) for Sentiss Made in Switzerland Rev. 05/24; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 5 mL NDC 72485-653-05 Loteprednol Etabonate Ophthalmic Suspension, 0.2% Rx only 5 mL container 5 mL carton 5 mL; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 10 mL NDC 72485-653-10 Loteprednol Etabonate Ophthalmic Suspension, 0.2% Rx only 10 mL container 10 mL carton 10 mL
- HOW SUPPLIED Loteprednol Etabonate Ophthalmic Suspension, 0.2% is supplied in a plastic bottle with a controlled drop tip in the following sizes: NDC 72485-653-05 5 ml in a 5 ml bottle NDC 72485-653-10 10 ml in a 10 ml bottle Storage: Store upright between 15° to 25°C (59° to 77°F). DO NOT FREEZE. DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Keep out of reach of children. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 USA Manufactured by: Ophtapham AG Riethofstrasse 1, Hettlingen, 8442, Switzerland (CHE) for Sentiss Made in Switzerland Rev. 05/24
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 5 mL NDC 72485-653-05 Loteprednol Etabonate Ophthalmic Suspension, 0.2% Rx only 5 mL container 5 mL carton 5 mL
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 10 mL NDC 72485-653-10 Loteprednol Etabonate Ophthalmic Suspension, 0.2% Rx only 10 mL container 10 mL carton 10 mL
Overview
Loteprednol Etabonate Ophthalmic Suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula: Chemical Name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate Each mL contains: ACTIVE: Loteprednol Etabonate 2 mg (0.2%); INACTIVES: Edetate Disodium, Glycerin, Povidone, Water for Injection and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3 to 5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium chloride 0.01%. structure
Indications & Usage
Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
Dosage & Administration
SHAKE VIGOROUSLY BEFORE USING. One drop instilled into the affected eye(s) four times daily.
Warnings & 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. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.
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. Loteprednol etabonate 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 to 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 mmHg) 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, the incidence of clinically significant increases in IOP (≥10 mm Hg) was 1 % (1/133) with loteprednol etabonate and 1 % (1/135) with placebo. To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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