Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING INVELTYS (loteprednol etabonate ophthalmic suspension) 1% is a sterile ophthalmic suspension. It is supplied in a white low-density polyethylene plastic dropper bottle with a controlled-drop linear low-density polyethylene tip, a pink high-density polyethylene cap, and a white low-density polyethylene tamper-evident overcap in the following size: 2.8 mL in a 5 mL bottle (NDC 71571-121-28) 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.; PRINCIPAL DISPLAY PANEL - 2.8 mL Bottle Carton NDC 71571-121-28 Rx Only INVELTYS ® (loteprednol etabonate ophthalmic suspension)1% Sterile 2.8 mL kala ® PHARMACEUTICALS NDC 71571-121-28 Rx Only INVELTYS ® (loteprednol etabonate ophthalmic suspension) 1% Sterile 2.8 mL Alcon FOR TOPICAL APPLICATION IN THE EYE. Dosage: See Prescribing Information. SHAKE FOR 1-2 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 300064651-1123 Store upright INVELTYS ® (loteprednol etabonate ophthalmic suspension) 1% Sterile NDC 71571-121-28 Rx Only Alcon Laboratories, Inc. 2.8 mL Bottle Carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING INVELTYS (loteprednol etabonate ophthalmic suspension) 1% is a sterile ophthalmic suspension. It is supplied in a white low-density polyethylene plastic dropper bottle with a controlled-drop linear low-density polyethylene tip, a pink high-density polyethylene cap, and a white low-density polyethylene tamper-evident overcap in the following size: 2.8 mL in a 5 mL bottle (NDC 71571-121-28) 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.
- PRINCIPAL DISPLAY PANEL - 2.8 mL Bottle Carton NDC 71571-121-28 Rx Only INVELTYS ® (loteprednol etabonate ophthalmic suspension)1% Sterile 2.8 mL kala ® PHARMACEUTICALS NDC 71571-121-28 Rx Only INVELTYS ® (loteprednol etabonate ophthalmic suspension) 1% Sterile 2.8 mL Alcon FOR TOPICAL APPLICATION IN THE EYE. Dosage: See Prescribing Information. SHAKE FOR 1-2 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 300064651-1123 Store upright INVELTYS ® (loteprednol etabonate ophthalmic suspension) 1% Sterile NDC 71571-121-28 Rx Only Alcon Laboratories, Inc. 2.8 mL Bottle 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: C 24 H 31 ClO 7 Mol. Wt. 467.0 INVELTYS (loteprednol etabonate ophthalmic suspension) 1% contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Each mL contains: ACTIVE: loteprednol etabonate 10 mg (1%) INACTIVES: glycerin, sodium citrate dihydrate, Poloxamer 407, sodium chloride, edetate disodium dihydrate, citric acid, and water for injection PRESERVATIVE: benzalkonium chloride 0.01% Chemical Structure
Indications & Usage
INVELTYS is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. INVELTYS is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. ( 1 )
Dosage & Administration
Shake for one to two seconds before using. ( 2 ) Instill one to two drops of INVELTYS into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. ( 2 ) 2.1 Dosage Information Instill one to two drops of INVELTYS into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. 2.2 Administration Instructions Instruct patient to wash hands well before each use. Shake for one to two seconds before using. If the patient is using other eye drops in addition to INVELTYS , advise the patient to wait at least 5 minutes between instillation of INVELTYS and other eye drops. 2.1 Dosage Information Instill one to two drops of INVELTYS into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. 2.2 Administration Instructions Instruct patient to wash hands well before each use. Shake for one to two seconds before using. If the patient is using other eye drops in addition to INVELTYS , advise the patient to wait at least 5 minutes between instillation of INVELTYS and other eye drops.
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 : 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 infections. In acute purulent conditions, steroids 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 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 may result in glaucoma with damage to the optic nerve, as well as 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 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 Use of 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 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 INVELTYS may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of INVELTYS and may be reinserted 15 minutes following administration.
Contraindications
INVELTYS 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. INVELTYS 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 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 were eye pain (1%) and posterior capsular opacification (1%). These reactions may have been the consequence of the surgical procedure. ( 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 drug reactions in the clinical trials with INVELTYS were eye pain and posterior capsular opacification, both reported in 1% of patients. These reactions may have been the consequence of the surgical procedure.
Storage & Handling
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.
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