DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. Removal of foreign bodies and sutures, and for tonometry: to drops (in single instillations) in each eye before operating.Deep ophthalmic anesthesia: drops in each eye at 90 second intervals for instillations.NOTE: The use of an eye patch is recommended.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Fluress(R) is supplied as mL contained in 10 mL plastic dropper bottle with separate sterile dropper applicator. (NDC 17478-640-10).

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE:. For procedures requiring disclosing agent in combination with an anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.

NURSING MOTHERS SECTION.

Nursing Mothers:. Caution should be exercised when Fluress(R) is administered to nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel Text for Container Label:. NDC 17478-640-10 Akorn Logo5 mLFLURESS(R) Fluorescein Sodium andBenoxinate HydrochlorideOphthalmic Solution, USP(0.25% 0.4%)Rx only Sterile. Figure.

PEDIATRIC USE SECTION.

Pediatric Use:. The safety and effectiveness of this product in pediatric patients has not been established.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS:. Occasional temporary stinging, burning and conjunctival redness have been reported after use of ocular anesthetics, as well as rare severe, immediate-type, apparently hyperallergic corneal reaction with acute, intense and diffuse epithelial keratitis, gray, ground glass appearance, sloughing or 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.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY:. Fluress(R) is the combination of disclosing agent with rapidly acting anesthetic agent of short duration.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. Known hypersensitivity to any component of this product.

DESCRIPTION SECTION.

DESCRIPTION:. Fluress(R) (Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP) is sterile ophthalmic solution combining disclosing agent with an anesthetic agent.Fluorescein sodium is disclosing agent with molecular formula C20H10Na2O5, molecular weight 376.28, and chemical structure:. Chemical Structure. Chemical Name:. Spiro[isobenzofuran-1 (3H), 9-[9H]xanthene]-3-one. 36-dihydroxy, Disodium saltBenoxinate Hydrochloride is an anesthetic agent with molecular formula C17H28N2O3oHCl, molecular weight 344.88, and chemical structure:. Chemical Structure. Chemical Name:. Benzoic acid, 4-amino-3-butoxyl-,2-(diethylamino) ethyl ester, monohydrochlorideEach mL contains:Actives: Benoxinate Hydrochloride mg (0.4%). Fluorescein Sodium 2.5 mg (0.25%).Preservative: Chlorobutanol 10 mg (1%).Inactives: Boric Acid, Povidone, Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (4.3 to 5.3), and Purified Water USP.

PRECAUTIONS SECTION.

PRECAUTIONS:. Fluress(R) (Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP) 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, systemic toxicity (manifested by central nervous system stimulation followed by depression) may occur.Protection of the eye from irritating 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.. Pregnancy:. Pregnancy Category C. Animal reproduction studies have not been conducted with Fluress(R). It is also not known whether Fluress(R) can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Fluress(R) should be given to pregnant woman only if clearly needed.. Nursing Mothers:. Caution should be exercised when Fluress(R) is administered to nursing woman.. Pediatric Use:. The safety and effectiveness of this product in pediatric patients has not been established.

PREGNANCY SECTION.

Pregnancy:. Pregnancy Category C. Animal reproduction studies have not been conducted with Fluress(R). It is also not known whether Fluress(R) can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Fluress(R) should be given to pregnant woman only if clearly needed.

SPL UNCLASSIFIED SECTION.

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP(0.25%/0.4%).

STORAGE AND HANDLING SECTION.

STORAGE:. Refrigerate at to 8C (36 to 46F). User may store at room temperature for up to one month. Store in carton until empty to protect from light. Keep tightly closed.U.S. PATENT NO. 3306820CANADIAN PATENT NO. 835940AkornManufactured by: Akorn, Inc.Lake Forest, IL 60045FS00N Rev 05/08.

WARNINGS SECTION.

WARNINGS:. NOT FOR INJECTION FOR TOPICAL OPHTHALMIC USE ONLY.Prolonged use of topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.KEEP OUT OF REACH OF CHILDREN.