DESCRIPTION

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is a disclosing agent with rapid anesthetic action and short duration.

Fluorescein sodium is represented by the following structural formula:

C20H10Na2O5
Mol. Wt. 376.28

Chemical Name: Spiro (isobenzofuran-1 (3H),9'-(9H) xanthene)-3-one, 3',6' dihydroxy-, disodium salt.

Benoxinate hydrochloride is represented by the following structural formula:

C17H28N2O3 • HCl
Mol. Wt. 344.88

Chemical Name: 2-(Diethylamino) ethyl 4-amino-3-butoxybenzoate monohydrochloride.

Each mL Contains: ACTIVES: Fluorescein Sodium 2.5 mg (0.25%), Benoxinate Hydrochloride 4 mg (0.4%); INACTIVES: Boric Acid, Povidone, Purified Water. Hydrochloric Acid may be added to adjust pH (4.3 – 5.3). PRESERVATIVE ADDED: Chlorobutanol 1%.

CLINICAL PHARMACOLOGY

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is the combination of a disclosing agent with a rapidly acting anesthetic of short duration.

INDICATIONS AND USAGE

For procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.

CONTRAINDICATIONS

Known hypersensitivity to any component of this product.

WARNINGS NOT FOR INJECTION- FOR TOPICAL OPHTHALMIC USE ONLY.

Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

PRECAUTIONS

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. The long-term toxicity is unknown; prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity manifested by central nervous system stimulation followed by depression may occur. Protection of the eye from irritation chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Patients should be advised to avoid touching the eye until the anesthesia has worn off.

ADVERSE REACTIONS

Occasional temporary stinging, burning, and conjunctival redness have been reported after use of ocular anesthetics, as well as a rare, severe, immediate-type, apparent hyper-allergic corneal reaction, with acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and sometimes, iritis with descemetitis.

Allergic contact dermatitis with drying and fissuring of the fingertips has been reported

DOSAGE AND ADMINISTRATION

Usual Dosage: Removal of foreign bodies and sutures, and for tonometry, 1 to 2 drops (in single instillations) in each eye before operating.

HOW SUPPLIED

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is supplied in a glass bottle with a sterilized dropper in the following size:

5 mL – NDC 24208-732-05

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 24208-732-05

BAUSCH + LOMB

Fluorescein Sodium and

Benoxinate Hydrochloride

Ophthalmic Solution USP,

0.25%/0.4%

(Sterile)

(with Sterilized Dropper)

5 mL

Rx only

9115101

AB30107