Benoxinate; fluorescein is an ophthalmic solution indicated for use in adults and pediatric patients undergoing an ophthalmic procedure that requires a disclosing agent and topical anesthesia. Benoxinate is a local anesthetic agent and fluorescein is a fluorescent dye that is used as a diagnostic aid. The solution is administered topically to the eye by a healthcare professional; after which, corneal anesthesia usually occurs in about 5 to 45 seconds and lasts for approximately 20 minutes. Subsequent doses may be administered as needed every 10 to 20 minutes. Instruct patients not to touch their eyes while the eye is insensitive (approximately 20 minutes after drug application) in order to avoid accidental ocular injury.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Ophthalmic Administration
-For administration by a healthcare provider prior to an ophthalmic procedure.
-Wash hands before and after use.
-To avoid contamination, do not touch the tip of the dropper to the eye, fingertips, or another surface.
-Instruct patients should avoid touching the eye until the anesthesia has worn off (approximately 20 minutes).
Prolonged use of topical ophthalmic anesthetics, such as benoxinate; fluorescein, can cause corneal epithelial toxicity which may progress to permanent corneal damage with accompanying visual loss (visual impairment). Other ocular adverse events associated with the administration of benoxinate; fluorescein include ocular or conjunctival hyperemia, ocular irritation (stinging), ocular pain (burning), blurred vision, and punctate keratitis.
Prolonged use or abuse of topical ophthalmic anesthetics, such as benoxinate; fluorescein, can cause corneal epithelial toxicity which may progress to permanent corneal damage with accompanying visual loss (visual disturbance).
Ophthalmic administration of benoxinate; fluorescein results in corneal anesthesia that lasts for approximately 20 minutes. Instruct patients not to touch their eyes while the eye is insensitive (20 minutes after drug application) to avoid accidental ocular trauma.
The manufacturer recommends that benoxinate; fluorescein be given during pregnancy only if the benefit to the mother outweighs the risk to the fetus. No adequate or well-controlled studies have been conducted in pregnant women, and it is unknown if the drug is associated with any adverse maternal or fetal outcomes.
There are no data on the presence of benoxinate or fluorescein in human milk after ophthalmic administration, the effects on the breast-fed infant, or the effects on milk production. Systemically administered fluorescein has been demonstrated to be excreted in human breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
For use in ophthalmic procedures requiring a disclosing agent and local ophthalmic anesthesia:
Ophthalmic dosage:
Adults: Instill 1 to 2 drops in the affected eye as needed to achieve adequate anesthesia. To extend the anesthetic effect, administer subsequent doses 10 to 20 minutes after the last dose.
Neonates, Infants, Children, and Adolescents: Instill 1 to 2 drops in the affected eye as needed to achieve adequate anesthesia. To extend the anesthetic effect, administer subsequent doses 10 to 20 minutes after the last dose.
Maximum Dosage Limits:
Maximum dosage limits are not available.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Benoxinate; Fluorescein products.
Mechanism of Action:-Benoxinate: Benoxinate is a rapidly acting (within 5 to 45 seconds) anesthetic agent of short duration (approximately 20 minutes).
-Fluorescein: Fluorescein is a fluorescent dye that is used as a diagnostic aid (a disclosing agent). The unbound fraction of the drug responds to electromagnetic radiation and light between the wavelengths of 465 to 490 nm and emits light at wavelengths of 520 to 530 nm. Thus, the fluorescein hydrocarbon is excited by blue light and emits yellowish-green light. Fluorescein is used topically to visualize the anterior surface of the eye. After topical application of fluorescein on the eye, a cobalt blue lamp or slit lamp device is used to visualize the anterior ocular surface for defects and for contact lens fittings.
Benoxinate; fluorescein is administered topically to the eye. The pharmacokinetic parameters of this drug combination have not been studied. If absorbed systemically, fluorescein undergoes rapid metabolism to fluorescein monoglucuronide. The parent drug and the metabolites are primarily eliminated by renal excretion. The estimated renal and hepatic (due to conjugation) clearance of fluorescein is 1.75 mL/min/kg and 1.50 mL/min/kg, respectively.
Affected cytochrome P450 isoenzymes: none
-Route-Specific Pharmacokinetics
Other Route(s)
Ophthalmic Route
The pharmacokinetics of the topical ophthalmic preparation of benoxinate; fluorescein is unknown.
-Fluorescein: When administered via topical ophthalmic preparation, fluorescein is highly water-soluble and thereby readily diffuses through intercellular fluid spaces. Staining is enhanced with cell degeneration or death, which increases membrane permeability. Staining is increased by rapid stromal diffusion and can manifest whenever there is a disruption of the cell-cell junctions.