Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Loteprednol Etabonate Ophthalmic Gel 0.5% is a sterile ophthalmic gel supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a pink polypropylene cap in the following size: NDC 72485-630-05 5 g in a 10 mL bottle Storage: Store upright at 15º to 25º C (59º to 77º F).; Principal Display Panel Text for Container Label: NDC 72485-630-05 Loteprednol Etabonate Ophthalmic Gel 0.5% FOR USE IN THE EYES ONLY Rx only Sterile 5 g container; Principal Display Panel Text for Carton Label: NDC 72485-630-05 Loteprednol Etabonate Ophthalmic Gel 0.5% FOR USE IN THE EYES ONLY Sterile 5 g Rx only carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING Loteprednol Etabonate Ophthalmic Gel 0.5% is a sterile ophthalmic gel supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a pink polypropylene cap in the following size: NDC 72485-630-05 5 g in a 10 mL bottle Storage: Store upright at 15º to 25º C (59º to 77º F).
- Principal Display Panel Text for Container Label: NDC 72485-630-05 Loteprednol Etabonate Ophthalmic Gel 0.5% FOR USE IN THE EYES ONLY Rx only Sterile 5 g container
- Principal Display Panel Text for Carton Label: NDC 72485-630-05 Loteprednol Etabonate Ophthalmic Gel 0.5% FOR USE IN THE EYES ONLY Sterile 5 g Rx only carton
Overview
Loteprednol etabonate is a corticosteroid. Its chemical name is chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Its molecular formula is C 24 H 31 ClO 7 and its chemical structure is: Loteprednol etabonate ophthalmic gel 0.5% contains a sterile, topical corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Each gram contains: ACTIVE: loteprednol etabonate 5 mg (0.5%) INACTIVES: boric acid, edetate disodium dihydrate, glycerin, polycarbophil, propylene glycol, sodium chloride, tyloxapol, water for injection, and sodium hydroxide to adjust to a pH of between 6 and 7 PRESERVATIVE: benzalkonium chloride 0.003% Chemical Structure
Indications & Usage
Loteprednol etabonate ophthalmic gel is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. Loteprednol etabonate ophthalmic gel is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery. ( 1 )
Dosage & Administration
Invert closed bottle and shake once to fill tip before instilling drops. Apply one to two drops of loteprednol etabonate ophthalmic gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. Invert closed bottle and shake once to fill tip before instilling drops. ( 2 ) Apply one to two drops of Loteprednol etabonate ophthalmic gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period. ( 2 )
Warnings & Precautions
Intraocular pressure (IOP) increase – Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored. ( 5.1 ) Cataracts - Use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) Delayed healing - The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. ( 5.3 ) Bacterial infections - Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infection. In acute purulent conditions, steroids may mask infection or enhance existing infection. ( 5.4 ) Viral infections - Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). ( 5.5 ) Fungal infections - Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. ( 5.6 ) 5.1 Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids, including loteprednol etabonate ophthalmic gel, may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored. 5.2 Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation. 5.3 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. 5.4 Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. 5.5 Viral Infections Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). 5.6 Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate. 5.7 Contact Lens Wear Patients should not wear contact lenses during their course of therapy with loteprednol etabonate ophthalmic gel.
Contraindications
Loteprednol etabonate ophthalmic gel is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, in mycobacterial infection of the eye and fungal diseases of ocular structures. Loteprednol etabonate ophthalmic gel is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, in mycobacterial infection of the eye and fungal diseases of ocular structures. ( 4 )
Adverse Reactions
Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. The most common adverse drug reactions reported in the clinical trials (2 to 5%) were anterior chamber inflammation, eye pain, and foreign body sensation. The most common adverse drug reactions (2 to 5%) were anterior chamber inflammation, eye pain, and foreign body sensation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
Storage: Store upright at 15º to 25º C (59º to 77º F).
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