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| Product NDC Code | 81046-0319 | ||||
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| Drug Name | Clobetasol propionate |
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| Type | Generic | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SUSPENSION/ DROPS | ||||
| Application Number | NDA218158 | ||||
| Labeler Name | Eyenovia, Inc. | ||||
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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 The following serious reactions are found elsewhere in the labeling: Intraocular Pressure (IOP) Increase [see Warnings and Precautions (5.1) ] Posterior Subcapsular Cataract Formation [see Warnings and Precautions (5.2) ] Delayed Healing [see Warnings and Precautions (5.3) ] Corneal and Scleral Melting [see Warnings and Precautions (5.4) ] Bacterial Infections [see Warnings and Precautions (5.5) ] Viral Infections [see Warnings and Precautions (5.6) ] Fungal Infections [see Warnings and Precautions (5.7) ] Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received clobetasol propionate ophthalmic suspension 0.05% included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%). Many of these reactions may have been the consequence of the surgical procedure ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. at 1-833-393-6684 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. Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received Clobetasol Propionate Ophthalmic Suspension 0.05% included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%). Many of 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 Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . 12.2 Pharmacodynamics In patients treated with Clobetasol Propionate Ophthalmic Suspension 0.05% twice daily for 21 days, the mean (SD) changes from baseline in cortisol concentrations, -18.1 (126.2) nmol/L and +5.1 (129.8) nmol/L for the Clobetasol Propionate Ophthalmic Suspension 0.05% and matching vehicle arms, respectively, were not statistically significant, considering the variability observed in the cortisol concentrations. 12.3 Pharmacokinetics After the first and second (12 hours apart) ocular instillations of Clobetasol Propionate Ophthalmic Suspension 0.05% in healthy adults (n=12), peak plasma clobetasol propionate concentrations (C max ) were below the lower limit of quantitation (LLOQ, 0.04 ng/mL) in 13 out of 22 PK profiles and ranged from 0.040 to 0.182 ng/mL in the other 9 profiles. Time to peak concentration (T max ) was observed between 0.5 - 1 hour post-dose. Clobetasol propionate concentrations declined to lower than LLOQ after 4 to 5 hours post-dose.
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 Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics In patients treated with Clobetasol Propionate Ophthalmic Suspension 0.05% twice daily for 21 days, the mean (SD) changes from baseline in cortisol concentrations, -18.1 (126.2) nmol/L and +5.1 (129.8) nmol/L for the Clobetasol Propionate Ophthalmic Suspension 0.05% and matching vehicle arms, respectively, were not statistically significant, considering the variability observed in the cortisol concentrations.
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 After the first and second (12 hours apart) ocular instillations of Clobetasol Propionate Ophthalmic Suspension 0.05% in healthy adults (n=12), peak plasma clobetasol propionate concentrations (C max ) were below the lower limit of quantitation (LLOQ, 0.04 ng/mL) in 13 out of 22 PK profiles and ranged from 0.040 to 0.182 ng/mL in the other 9 profiles. Time to peak concentration (T max ) was observed between 0.5 - 1 hour post-dose. Clobetasol propionate concentrations declined to lower than LLOQ after 4 to 5 hours post-dose.
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 Clobetasol Propionate Ophthalmic Suspension 0.05% is contraindicated in most active 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. Clobetasol Propionate Ophthalmic Suspension 0.05% is contraindicated in most active 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 Clobetasol Propionate Ophthalmic Suspension 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, that has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate and it has the following structural formula: Clobetasol propionate has the empirical formula C 25 H 32 CIFO 5 and a molecular weight of 467. Clobetasol Propionate Ophthalmic Suspension 0.05% contains a sterile, anti-inflammatory corticosteroid for topical ophthalmic use. Each mL of Clobetasol Propionate Ophthalmic Suspension 0.05% contains: ACTIVE: clobetasol propionate 0.5 mg (0.05%) INACTIVES: sodium chloride, hydrogenated soybean lecithin, citric acid, glycerin, poloxamer 407, polyvinyl alcohol, boric acid, edetate disodium dihydrate, methylcellulose, trisodium citrate, and water for injection PRESERVATIVE: benzalkonium chloride 0.0036%. 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 Instill one drop of clobetasol propionate ophthalmic suspension 0.05% into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. ( 2.1 ) Wash hands well before each use. ( 2.2 ) 2.1 Recommended Dosage Instill one drop of Clobetasol Propionate Ophthalmic Suspension 0.05% 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 Wash hands well before each use. If using other eye drops in addition to Clobetasol Propionate Ophthalmic Suspension 0.05%, wait at least 5 minutes between instillation of Clobetasol Propionate Ophthalmic Suspension 0.05% 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 clobetasol propionate 0.05% (0.5 mg/mL). Ophthalmic suspension containing clobetasol propionate 0.05%. ( 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 Clobetasol Propionate Ophthalmic Suspension 0.05% is indicated for the treatment of post-operative inflammation and pain following ocular surgery. Clobetasol Propionate Ophthalmic Suspension 0.05% 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.CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL SODIUM CHLORIDE HYDROGENATED SOYBEAN LECITHIN ANHYDROUS CITRIC ACID GLYCERIN POLOXAMER 407 POLYVINYL ALCOHOL, UNSPECIFIED BORIC ACID EDETATE DISODIUM BENZALKONIUM CHLORIDE METHYLCELLULOSE, UNSPECIFIED ANHYDROUS TRISODIUM CITRATE WATER
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 Carcinogenesis Long-term animal studies have not been performed with Clobetasol Propionate Ophthalmic Suspension 0.05% to evaluate the carcinogenic potential of clobetasol propionate. Mutagenesis Clobetasol propionate was not mutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test. Impairment of Fertility Fertility studies in the rat following subcutaneous administration at dosage levels up to 50 µg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. This dose is approximately 10 times the recommended human ophthalmic dose of Clobetasol Propionate Ophthalmic Suspension 0.05% (0.83 μg/kg/day), estimated based on body surface area and assuming 100% systemic absorption. Note that systemic levels of clobetasol propionate following topical ocular administration are minimal [see Clinical Pharmacology (12.3) ] .
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies have not been performed with Clobetasol Propionate Ophthalmic Suspension 0.05% to evaluate the carcinogenic potential of clobetasol propionate. Mutagenesis Clobetasol propionate was not mutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test. Impairment of Fertility Fertility studies in the rat following subcutaneous administration at dosage levels up to 50 µg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. This dose is approximately 10 times the recommended human ophthalmic dose of Clobetasol Propionate Ophthalmic Suspension 0.05% (0.83 μg/kg/day), estimated based on body surface area and assuming 100% systemic absorption. Note that systemic levels of clobetasol propionate following topical ocular administration are minimal [see Clinical Pharmacology (12.3) ] .
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 - 3.5 mL Bottle Carton NDC #: 81046-0319-1 Clobetasol Propionate Ophthalmic Suspension 0.05% FOR TOPICAL APPLICATION IN THE EYE Sterile Rx only 3.5 mL eyenovia PRINCIPAL DISPLAY PANEL - 3.5 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: Eyenovia Inc. by Formosa Pharmaceuticals Inc
CLOBETASOL PROPIONATE: 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 with Other Eye Drops Advise patients to wait at least 5 minutes between instillation of Clobetasol Propionate Ophthalmic Suspension 0.05% and other eye drops if using other eye drops in addition to Clobetasol Propionate Ophthalmic Suspension 0.05%. 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 ophthalmic suspension. When to Seek Physician Advice Advise patients to consult a physician if pain develops; or if redness, itching, or inflammation becomes aggravated. Contact Lens Wear Advise patients that the preservative in Clobetasol Propionate Ophthalmic Suspension 0.05% may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of Clobetasol Propionate Ophthalmic Suspension 0.05% and may be reinserted after 15 minutes following administration.
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-center, randomized, double-masked, vehicle-controlled trials in which patients had ≥10 cells in the anterior chamber after cataract surgery were assigned to Clobetasol Propionate Ophthalmic Suspension 0.05% (N=366) or vehicle (N=382) (NCT04739709 (Study 1) and NCT04810962 (Study 2)). One drop of Clobetasol Propionate Ophthalmic Suspension 0.05% or vehicle was self-administered twice a day for 14 days, beginning on the day after surgery. Complete resolution of inflammation (an anterior chamber 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) were assessed at post-operative day (POD) 4, 8, and 15. The co-primary efficacy endpoints were the proportion of subjects with Anterior Chamber Cell (ACC) count = 0 (ACC grade = 0) at POD8 maintained through POD15, and the proportion of subjects with Ocular Pain Grade = 0 at POD4 maintained through POD15. In the intent-to-treat analysis, both co-primary efficacy endpoints were statistically significantly better in Clobetasol Propionate Ophthalmic Suspension 0.05%-treated patients compared to vehicle-treated patients (p<0.01). The clinical trial efficacy results from both studies are provided below. Figure 1: Percent of Patients with Anterior Chamber Cell Count = 0 at Post-Operative Days 8 and 15 Figure 2: Percent of Patients with Complete Resolution of Pain at Post-Operative Days 4, 8, and 15 Figure 1 Figure 1 Figure 2 Figure 2
| Figure 1: Percent of Patients with Anterior Chamber Cell Count = 0 at Post-Operative Days 8 and 15 | |
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| Figure 2: Percent of Patients with Complete Resolution of Pain at Post-Operative Days 4, 8, and 15 | |
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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.8.5 Geriatric Use No overall differences in safety and effectiveness of Clobetasol Propionate Ophthalmic Suspension 0.05% have been observed between patients 65 years of age and older and younger adult 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.8.4 Pediatric Use The safety and effectiveness of Clobetasol Propionate Ophthalmic Suspension 0.05% 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 There are no adequate and well-controlled clinical studies of Clobetasol Propionate Ophthalmic Suspension 0.05% administration in pregnant women to inform drug-associated risks. Plasma concentrations of clobetasol propionate were minimal following topical ophthalmic administration of Clobetasol Propionate Ophthalmic Suspension 0.05% [see Clinical Pharmacology (12.3) ] . However, corticosteroids, including clobetasol propionate have been shown to be teratogenic and fetotoxic in laboratory animals when administered systemically at relatively low dosage levels (see Data ) . Clobetasol Propionate Ophthalmic Suspension 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryofetal development studies in mice, clobetasol propionate was fetotoxic at the highest subcutaneous dose tested (1 mg/kg) and teratogenic at all subcutaneous dose levels tested down to 0.03 mg/kg. Abnormalities observed included cleft palate and skeletal abnormalities. These doses are approximately 98 times and 3 times, respectively, the recommended human ophthalmic dose of Clobetasol Propionate Ophthalmic Suspension 0.05%, estimated based on body surface area and assuming 100% systemic absorption. In embryofetal development studies in rabbits, clobetasol propionate was teratogenic at subcutaneous doses of 3 and 10 µg/kg. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. These doses are approximately 1.2 times and 3.9 times, respectively, the recommended human ophthalmic dose of Clobetasol Propionate Ophthalmic Suspension 0.05%, estimated based on body surface area and assuming 100% systemic absorption.
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 There are no adequate and well-controlled clinical studies of Clobetasol Propionate Ophthalmic Suspension 0.05% administration in pregnant women to inform drug-associated risks. Plasma concentrations of clobetasol propionate were minimal following topical ophthalmic administration of Clobetasol Propionate Ophthalmic Suspension 0.05% [see Clinical Pharmacology (12.3) ] . However, corticosteroids, including clobetasol propionate have been shown to be teratogenic and fetotoxic in laboratory animals when administered systemically at relatively low dosage levels (see Data ) . Clobetasol Propionate Ophthalmic Suspension 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryofetal development studies in mice, clobetasol propionate was fetotoxic at the highest subcutaneous dose tested (1 mg/kg) and teratogenic at all subcutaneous dose levels tested down to 0.03 mg/kg. Abnormalities observed included cleft palate and skeletal abnormalities. These doses are approximately 98 times and 3 times, respectively, the recommended human ophthalmic dose of Clobetasol Propionate Ophthalmic Suspension 0.05%, estimated based on body surface area and assuming 100% systemic absorption. In embryofetal development studies in rabbits, clobetasol propionate was teratogenic at subcutaneous doses of 3 and 10 µg/kg. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. These doses are approximately 1.2 times and 3.9 times, respectively, the recommended human ophthalmic dose of Clobetasol Propionate Ophthalmic Suspension 0.05%, estimated based on body surface area and assuming 100% systemic absorption. 8.2 Lactation Risk Summary There is no information regarding the presence of clobetasol propionate in human milk, the effects on the breastfed infant, or the effects on milk production. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. However, systemic levels of clobetasol propionate following topical ocular administration are minimal [see Clinical Pharmacology (12.3) ], and it is not known whether measurable levels of clobetasol propionate would be present in maternal milk following topical ocular administration. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Clobetasol Propionate Ophthalmic Suspension 0.05%, and any potential adverse effects on the breastfed infant from Clobetasol Propionate Ophthalmic Suspension 0.05%. 8.4 Pediatric Use The safety and effectiveness of Clobetasol Propionate Ophthalmic Suspension 0.05% in pediatric patients have not been established. 8.5 Geriatric Use No overall differences in safety and effectiveness of Clobetasol Propionate Ophthalmic Suspension 0.05% have been observed between patients 65 years of age and older and younger adult 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 16.1 How Supplied Clobetasol Propionate Ophthalmic Suspension 0.05% (0.5 mg/mL) is a sterile ophthalmic suspension. It is supplied in a multi-dose white low-density polyethylene plastic 5 mL eye-dropper bottle with a low-density polyethylene white tip and a high-density polyethylene pink cap with a tamper-proof ring at the bottom of the cap. 3.5 mL in a 5 mL bottle (NDC 81046-0319-1) 16.2 Storage and Handling Do not use if tamper-evident ring seal is broken. Keep the bottle tightly closed with the pink cap when not in use. Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. After opening, Clobetasol Propionate Ophthalmic Suspension 0.05% can be used until the expiration date on the bottle.
Storage and handling
Information about safe storage and handling of the drug product.16.2 Storage and Handling Do not use if tamper-evident ring seal is broken. Keep the bottle tightly closed with the pink cap when not in use. Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. After opening, Clobetasol Propionate Ophthalmic Suspension 0.05% can be used until the expiration date on the bottle.
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