Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a sterile, yellow to orange-red solution supplied in a 5 mL glass bottle with a sterilized dropper. NDC #59390-218-05 Storage : Store in refrigerator at 2° to 8°C (36° to 46°F). After opening, Altafluor Benox can be stored up to one month if stored at room temperature or until the expiration date on the bottle if stored in refrigerated conditions. Keep tightly closed.; PRINCIPAL DISPLAY PANEL NDC 59390-218-05 ALTAFLUOR BENOX Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP 0.25%/0.4% (Sterile) 5 mL Rx Only NDC 59390-218-05 ALTAFLUOR BENOX Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP 0.25%/0.4% (Sterile) 5 mL Rx Only
- 16 HOW SUPPLIED/STORAGE AND HANDLING Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a sterile, yellow to orange-red solution supplied in a 5 mL glass bottle with a sterilized dropper. NDC #59390-218-05 Storage : Store in refrigerator at 2° to 8°C (36° to 46°F). After opening, Altafluor Benox can be stored up to one month if stored at room temperature or until the expiration date on the bottle if stored in refrigerated conditions. Keep tightly closed.
- PRINCIPAL DISPLAY PANEL NDC 59390-218-05 ALTAFLUOR BENOX Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP 0.25%/0.4% (Sterile) 5 mL Rx Only NDC 59390-218-05 ALTAFLUOR BENOX Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP 0.25%/0.4% (Sterile) 5 mL Rx Only
Overview
Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a sterile disclosing agent in combination with a short-acting ester anesthetic for topical ophthalmic use. Fluorescein sodium is represented by the following structural formula: C 20 H 10 Na 2 O 5 Mol. Wt. 376.27 Chemical Name: Spiro [isobenzofuran-1 (3 H ),9’-9[9 H ] xanthene]-3-one, 3’,6’ dihydroxy, disodium salt. Benoxinate hydrochloride is represented by the following structural formula: C 17 H 28 N 2 O 3 • HCl Mol. Wt. 344.88 Chemical Name: 2-(Diethylamino) etyl 4-amino-3-butoxybenzoate monohydrochloride. Each mL contains: Actives: fluorescein sodium 2.5 mg (0.25%) equivalent to fluorescein 2.2 mg (0.22%), benoxinate hydrochloride 4 mg (0.4%) equivalent to benoxinate 3.6 mg (0.36%); Inactives: povidone, hydrochloric acid, boric acid, sodium hydroxide, water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.3 – 5.3). Preservative: chlorobutanol 11mg (1.1%). Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is a disclosing agent with rapid anesthetic action of short duration. Fluorescein Sodium is represented by the following structural formula. Benoxinate Hydrochloride is represented by the following structural formula:
Indications & Usage
Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a combination disclosing agent and local ester anesthetic indicated for procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic. ( 1 )
Dosage & Administration
Instill 1 to 2 drops of Altafluor Benox in the eye as needed. Instill 1 to 2 drops topically in the eye as needed to achieve adequate anesthesia. ( 2 )
Warnings & Precautions
Corneal toxicity: Prolonged use or abuse may lead to corneal epithelial toxicity and manifest as epithelial defects which may progress to permanent corneal damage. ( 5.1 ) 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 which may manifest as epithelial defects and progress to permanent corneal opacification with accompanying visual loss. 5.2 Corneal Injury Due to Insensitivity Patient should not touch the eye for approximately 20 minutes after using this anesthetic as accidental injuries can occur due to insensitivity of the eye.
Contraindications
: Altafluor Benox is contraindicated in patients with known hypersensitivity to any component of this product. Known hypersensitivity to any component of this product. ( 4 )
Adverse Reactions
The following 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 0.25% / 0.4%: ocular hyperemia, burning, stinging, eye irritation, blurred vision and punctate keratitis. Because these reactions were 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 Altaire Pharmaceuticals, Inc., at 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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