Fluorescein Sodium and Benoxinate Hydrochloride

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a combination of fluorescein sodium, a disclosing agent and benoxinate hydrochloride, a local ester anesthetic indicated for procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic. ( 1 )

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a yellow to orange-red ophthalmic solution containing fluorescein sodium 2.6 mg/mL (0.3%) and benoxinate hydrochloride 4.4 mg/mL (0.4%). Ophthalmic solution containing fluorescein sodium 2.6 mg/mL (0.3%) and benoxinate hydrochloride 4.4 mg/mL (0.4%). ( 3 )

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is contraindicated in patients with known hypersensitivity to any component of this product. Known hypersensitivity to any component of this product. ( 4 )

Corneal Toxicity : Prolonged use or abuse may lead to corneal epithelial toxicity and manifest as epithelial defects which may progress to permanent corneal damage. ( Error! Hyperlink reference not valid. ) Corneal Injury : Patients should not touch the eye for approximately 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. ( 5.2 )

5.1 Corneal Toxicity Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage with accompanying visual loss.

5.2 Corneal Injury Due to Insensitivity Patients should not touch the eye for approximately 20 minutes after using this anesthetic as accidental injuries can occur due to insensitivity of the eye.

The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal Toxicity [see Warnings and Precautions (5.1) ] Corneal Injury Due to Insensitivity [see Warnings and Precautions (5.2) ] The following adverse reactions have been identified following use of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%: ocular hyperemia, burning, stinging, eye irritation, blurred vision and punctate keratitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common ocular adverse events are: stinging, burning and conjunctival redness. ( 6) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary There are no available data on the use of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% in pregnant women to inform any drug associated risk. Adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% should be given to a pregnant woman only if clearly needed.

8.2 Lactation Risk Summary There are no data on the presence of fluorescein sodium or benoxinate hydrochloride in human milk after ocular administration of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%, and any potential adverse effects on the breastfed infant from Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%.

8.4 Pediatric Use The safety and effectiveness of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% have been established for pediatric patients. Use of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is supported in pediatric patients by evidence from adequate and well controlled studies.

8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.