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| Product NDC Code | 71571-121 | ||||||
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| Drug Name | Inveltys |
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| Type | Brand | ||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SUSPENSION | ||||||
| RxCUI drug identifier | 2055281, 2055286 |
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| Application Number | NDA210565 | ||||||
| Labeler Name | ALCON LABORATORIES, INC. | ||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor-dependent modulation of inflammation are not clearly established. However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms. 12.3 Pharmacokinetics Loteprednol etabonate is lipid soluble and can penetrate into cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon in vivo and in vitro preclinical metabolism studies, loteprednol etabonate undergoes extensive metabolism to inactive carboxylic acid metabolites, PJ-91 and PJ-90. Following twice-daily unilateral topical ocular dosing of INVELTYS for 14 days in healthy subjects, the plasma concentrations of loteprednol etabonate were below the limit of quantitation (1 ng/mL) at all timepoints.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor-dependent modulation of inflammation are not clearly established. However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Loteprednol etabonate is lipid soluble and can penetrate into cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon in vivo and in vitro preclinical metabolism studies, loteprednol etabonate undergoes extensive metabolism to inactive carboxylic acid metabolites, PJ-91 and PJ-90. Following twice-daily unilateral topical ocular dosing of INVELTYS for 14 days in healthy subjects, the plasma concentrations of loteprednol etabonate were below the limit of quantitation (1 ng/mL) at all timepoints.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 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 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION 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
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND 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.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Ophthalmic suspension containing 10 mg/mL of loteprednol etabonate. Ophthalmic suspension containing 10 mg/mL of loteprednol etabonate. ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND 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 )
Spl product data elements
Usually a list of ingredients in a drug product.Inveltys loteprednol etabonate LOTEPREDNOL ETABONATE LOTEPREDNOL GLYCERIN TRISODIUM CITRATE DIHYDRATE SODIUM CHLORIDE EDETATE DISODIUM CITRIC ACID MONOHYDRATE WATER Bottle 2.8ml carton label
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma thymidine kinase (tk) assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma thymidine kinase (tk) assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 USA U.S. Pat.: www.alconpatents.com © 2023 Alcon Inc. Alcon
Inveltys: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Administration Instruct the patient to shake the bottle 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. Risk of Contamination Advise patients to wash their hands well before each use. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the suspension. Risk of Secondary Infection Advise the patient to consult a physician if pain develops, or redness, itching, or inflammation becomes aggravated. Contact Lens Wear Advise patients that 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 after 15 minutes following administration.
Instructions for use
Information about safe handling and use of the drug product.INSTRUCTIONS FOR USE INVELTYS [in-vel-tis] (loteprednol etabonate ophthalmic suspension) 1% for topical ophthalmic use This Instructions for Use contains information on how to properly administer INVELTYS. Important Information You Need to Know Before Using INVELTYS INVELTYS is for use in the eye only. Wash your hands before using INVELTYS. Do not use if the tamper-evident seal is not intact. Do not let the INVELTYS dropper tip touch your eye, fingers, or any other surfaces to avoid contamination or injury to your eye. Use INVELTYS exactly as your healthcare provider tells you to. If you are using INVELTYS with other eye (ophthalmic) medicines, you should wait at least 5 minutes between using INVELTYS and the other medicine. If you wear contact lenses, remove them before using INVELTYS. Put the pink cap back on INVELTYS after each use. Before you use INVELTYS for the first time: There are two caps on your bottle of INVELTYS. Hold the bottle firmly by its neck. Remove the white cap by twisting it clockwise (See Figure A ) . Throw away the white cap. INVELTYS is now ready to use. Figure A Follow Steps 1 to 6 each time you use INVELTYS. Step 1. Wash your hands well. Step 2. Shake the INVELTYS bottle for 1 to 2 seconds (See Figure B ) . Figure B Step 3: Remove the pink cap from the top of the INVELTYS dropper by turning it counterclockwise (See Figure C ) . Keep the pink cap. Do not let the INVELTYS dropper tip touch your eye, fingers, or any other surface. Figure C Step 4: Turn the INVELTYS bottle upside down (See Figure D ) . Figure D Step 5: Tilt your head back. Hold the bottle directly above your affected eye. Squeeze the middle of the INVELTYS bottle gently to put 1 to 2 drops (follow your doctor's recommendation) into the affected eye (See Figure E ) . Figure E Step 6: Place the pink cap back onto the INVELTYS bottle and tighten by turning clockwise (See Figure F ) . Figure F If you use contact lenses, wait for 15 minutes before placing them back in. How should I store INVELTYS? Store INVELTYS upright at 59ºF to 77ºF (15ºC to 25ºC). Do not freeze. Keep INVELTYS and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Revised: 11/2023 figurea figureb figurec figured figuree figuref
| Wash your hands well. | |
| Shake the INVELTYS bottle for 1 to 2 seconds | |
| Remove the pink cap from the top of the INVELTYS dropper by turning it | |
| Turn the INVELTYS bottle upside down | |
| Tilt your head back. Hold the bottle directly above your affected eye. Squeeze the middle of the INVELTYS bottle gently to put 1 to 2 drops (follow your doctor's recommendation) into the affected eye | |
| Place the pink cap back onto the INVELTYS bottle and tighten by turning clockwise | |
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES Clinical efficacy was evaluated in 2 multi-centered, randomized, double-masked, placebo-controlled trials in which patients with an anterior cell grade greater than or equal to "2" (a cell count of 6 or higher using a slit-lamp biomicroscope) after cataract surgery were assigned to INVELTYS or placebo (vehicle) following surgery (NCT # 02163824 and NCT # 02793817). One to two drops of INVELTYS or vehicle was self-administered twice a day for 14 days, beginning the day after surgery. Complete resolution of inflammation (a cell count of 0 maintained through day 15 without rescue medication) and complete resolution of pain (a patient-reported pain grade of 0 maintained through day 15 without rescue medication) was assessed 4, 8, and 15 days post-surgery. In the intent-to-treat analysis of both studies, a significant benefit was seen in the INVELTYS -treated group for complete resolution of ocular inflammation at Days 8 and 15, and complete resolution of pain at Days 4, 8, and 15, when compared with placebo. The consolidated clinical trial results are provided below. Figure 1 Consolidated Clinical Trial Data: Percent of Patients with Complete Resolution of Anterior Chamber Cells (Cell Count = 0) at Days 8 and 15 * p-values < 0.01 for treatment comparisons Figure 2 Consolidated Clinical Trial Data: Percent of Patients Who Were Pain Free at Days 4, 8, and 15 * p-values < 0.01 for treatment comparisons Figure 1 Figure 2
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.4 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.3 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary INVELTYS is not absorbed systemically following topical ophthalmic administration and maternal use is not expected to result in fetal exposure to the drug.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary INVELTYS is not absorbed systemically following topical ophthalmic administration and maternal use is not expected to result in fetal exposure to the drug. 8.2 Lactation Risk Summary INVELTYS is not absorbed systemically by the mother following topical ophthalmic administration, and breastfeeding is not expected to result in exposure of the child to INVELTYS . 8.3 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.4 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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.
Storage and handling
Information about safe storage and handling of the drug product.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API