CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE- clobetasol propionate suspension/ drops
Eyenovia, Inc.

1 INDICATIONS AND USAGE

Clobetasol Propionate Ophthalmic Suspension 0.05% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

2 DOSAGE AND ADMINISTRATION

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.

3 DOSAGE FORMS AND STRENGTHS

Ophthalmic suspension containing clobetasol propionate 0.05% (0.5 mg/mL).

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.

5 WARNINGS AND PRECAUTIONS

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. Steroids should be used with caution in the presence of glaucoma. If Clobetasol Propionate Ophthalmic Suspension 0.05% is used for 10 days or longer, IOP should be monitored.

5.2 Cataracts

Prolonged use of corticosteroids may result in posterior subcapsular cataract formation.

5.3 Delayed Healing

The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation.

5.4 Corneal and Scleral Melting

In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. 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.

5.5 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. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated.

5.6 Viral Infections

Employment 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).

5.7 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 culture should be taken when appropriate.

5.8 Risk of Contamination

Do not allow the dropper tip to touch any surface, as this may contaminate the ophthalmic suspension.

5.9 Contact Lens Wear

Clobetasol Propionate Ophthalmic Suspension 0.05% should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of Clobetasol Propionate Ophthalmic Suspension 0.05%. The preservative in Clobetasol Propionate Ophthalmic Suspension 0.05% may be absorbed by soft contact lenses. Lenses may be reinserted after 15 minutes following administration of clobetasol propionate ophthalmic suspension 0.05%.

6 ADVERSE REACTIONS

The following serious reactions are found elsewhere in the labeling:

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.

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%.

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