Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% is a sterile ophthalmic suspension. It is supplied in a white, low-density polyethylene dropper bottle with a linear low-density polyethylene tip, a pink high-density polyethylene cap, and a white low-density polyethylene tamper-evident overcap in the following size: 8.3 mL in a 10 mL bottle (NDC 71571-333-83) Storage and Handling Do not use if tamper-evident overcap seal is not intact. The white tamper-evident overcap can be thrown away. Retain the pink cap and keep the bottle tightly closed when not in use. Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. After opening, EYSUVIS can be used until the expiration date on the bottle.; PRINCIPAL DISPLAY PANEL - NDC: 71571-333-83 - Bottle Label NDC 71571-333-83 Rx Only EYsuVIS ® (loteprednol etabonate ophthalmic suspension) 0.25% Sterile 8.3 mL FOR TOPICAL APPLICATION IN THE EYE. Dosage: See Prescribing Information. Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 USA; PRINCIPAL DISPLAY PANEL - NDC: 71571-333-83 - Carton Label NDC 71571-333-83 Rx Only EYsuVIS ® (loteprednol etabonate ophthalmic suspension) 0.25% FOR TOPICAL APPLICATION IN THE EYE. Sterile 8.3 mL Alcon Dosage: See Prescribing Information. SHAKE FOR 2 TO 3 SECONDS Storage: Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. DO NOT USE IF TAMPER-EVIDENT OVERCAP IS NOT INTACT 300064649-1123 Store Upright Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 USA; PRINCIPAL DISPLAY PANEL - NDC: 71571-333-24 - Bottle Label; PRINCIPAL DISPLAY PANEL - NDC: 71571-333-24 - Carton Label; PRINCIPAL DISPLAY PANEL - NDC: 71571-333-01 - Bottle Label; PRINCIPAL DISPLAY PANEL - NDC: 71571-333-01 - Carton Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% is a sterile ophthalmic suspension. It is supplied in a white, low-density polyethylene dropper bottle with a linear low-density polyethylene tip, a pink high-density polyethylene cap, and a white low-density polyethylene tamper-evident overcap in the following size: 8.3 mL in a 10 mL bottle (NDC 71571-333-83) Storage and Handling Do not use if tamper-evident overcap seal is not intact. The white tamper-evident overcap can be thrown away. Retain the pink cap and keep the bottle tightly closed when not in use. Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. After opening, EYSUVIS can be used until the expiration date on the bottle.
- PRINCIPAL DISPLAY PANEL - NDC: 71571-333-83 - Bottle Label NDC 71571-333-83 Rx Only EYsuVIS ® (loteprednol etabonate ophthalmic suspension) 0.25% Sterile 8.3 mL FOR TOPICAL APPLICATION IN THE EYE. Dosage: See Prescribing Information. Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 USA
- PRINCIPAL DISPLAY PANEL - NDC: 71571-333-83 - Carton Label NDC 71571-333-83 Rx Only EYsuVIS ® (loteprednol etabonate ophthalmic suspension) 0.25% FOR TOPICAL APPLICATION IN THE EYE. Sterile 8.3 mL Alcon Dosage: See Prescribing Information. SHAKE FOR 2 TO 3 SECONDS Storage: Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. DO NOT USE IF TAMPER-EVIDENT OVERCAP IS NOT INTACT 300064649-1123 Store Upright Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 USA
- PRINCIPAL DISPLAY PANEL - NDC: 71571-333-24 - Bottle Label
- PRINCIPAL DISPLAY PANEL - NDC: 71571-333-24 - Carton Label
- PRINCIPAL DISPLAY PANEL - NDC: 71571-333-01 - Bottle Label
- PRINCIPAL DISPLAY PANEL - NDC: 71571-333-01 - Carton Label
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: C 24 H 31 ClO 7 Mol. Wt. 467.0 EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Each mL contains: ACTIVE: loteprednol etabonate 2.5 mg (0.25%) INACTIVES: glycerin, sodium citrate dihydrate, sodium chloride, Poloxamer 407, edetate disodium dihydrate, citric acid, and water for injection. PRESERVATIVE: benzalkonium chloride 0.01% Chemical Structure
Indications & Usage
EYSUVIS is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. EYSUVIS is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. ( 1 )
Dosage & Administration
Shake for two to three seconds before using. ( 2 ) Instill one to two drops of EYSUVIS into each eye four times daily. ( 2 ) 2.1 Dosage Information Instill one to two drops of EYSUVIS into each eye four times daily for up to two weeks. This product should only be renewed after examination under magnification such as a slit lamp and evaluation of the intraocular pressure. [see Warnings and Precautions (5.1) and (5.2) ] . 2.2 Administration Instructions Instruct patient to wash hands well before each use. Shake for two to three seconds before using. If the patient is using other eye drops in addition to EYSUVIS, advise the patient to wait at least 5 minutes between instillation of EYSUVIS and other eye drops. If a dose is missed, take the missed dose when remembered.
Warnings & Precautions
Delayed Healing and Corneal Perforation :The initial prescription and each 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. ( 5.1 ) 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. Renewal of the medication order should be made by a physician only after examination of the patient and evaluation of the IOP.( 5.2 ) Cataracts : Use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.3 ) Bacterial Infections : Use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection. ( 5.4 ) Viral Infections : Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids 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 corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. ( 5.6 ) 5.1 Delayed Healing and Corneal Perforation Topical corticosteroids have been known to delay healing and cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. The initial prescription and each 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. 5.2 Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision. Corticosteroids should be used with caution in the presence of glaucoma. Renewal of the medication order should be made by a physician only after examination of the patient and evaluation of the IOP. 5.3 Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation. 5.4 Bacterial Infections Use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection. 5.5 Viral Infections Use of corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids 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 corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate. 5.7 Risk of Contamination Do not to allow the dropper tip to touch any surface, as this may contaminate the suspension. 5.8 Contact Lens Wear The preservative in EYSUVIS may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of EYSUVIS and may be reinserted 15 minutes following administration.
Contraindications
EYSUVIS, 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. EYSUVIS, 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. ( 4 )
Adverse Reactions
Adverse reactions associated with ophthalmic corticosteroids 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 reaction following the use of EYSUVIS for two weeks was instillation site pain, which was reported in 5% of patients. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction observed in clinical trials with EYSUVIS was instillation site pain, which was reported in 5% of patients.
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