Fluorescein Sodium and Proparacaine Hydrochloride FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE ALTAIRE PHARMACEUTICALS INC. FDA Approved Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is a sterile ophthalmic solution combining the disclosing action of Fluorescein with the anesthetic action of Proparacaine Hydrochloride. The active ingredient, Fluorescein Sodium , has the chemical name Spiro [isobenzofuran-1 (3H), 9'-[9H]xanthene]-3-one, 3' ,6' dihydroxy-,disodium salt. It is represented by the following structural formula: The active ingredient, Proparacaine Hydrochloride , has the chemical name Benzoic acid, 3-amino-4-propoxy-, 2-[diethylamino]ethyl ester monohydrochloride. It is represented by the following structural formula: EACH mL CONTAINS : ACTIVES: Fluorescein Sodium, USP, 0.25% [2.5 mg]. Proparacaine Hydrochloride, USP, 0.5% [5mg]; INACTIVES: Povidone, Boric Acid, Water for Injection, Sodium Hydroxide, or/and Hydrochloric Acid may be added to adjust pH. PRESERVATIVE: Methylparaben 0.1%. structural formula structural formula
FunFoxMeds bottle
Substance Fluorescein Sodium
Route
OPHTHALMIC
Package NDC

Drug Facts

Composition & Profile

Strengths
5 ml
Quantities
5 ml
Treats Conditions
Description Fluorescein Sodium And Proparacaine Hydrochloride Ophthalmic Solution Usp Sterile Is A Sterile Ophthalmic Solution Combining The Disclosing Action Of Fluorescein With The Anesthetic Action Of Proparacaine Hydrochloride The Active Ingredient Fluorescein Sodium Has The Chemical Name Spiro Isobenzofuran 1 3h 9 9h Xanthene 3 One 3 6 Dihydroxy Disodium Salt It Is Represented By The Following Structural Formula The Active Ingredient Proparacaine Hydrochloride Has The Chemical Name Benzoic Acid 3 Amino 4 Propoxy 2 Diethylamino Ethyl Ester Monohydrochloride It Is Represented By The Following Structural Formula Each Ml Contains Actives Fluorescein Sodium Usp 0 25 2 5 Mg Proparacaine Hydrochloride 0 5 5mg Inactives Povidone Boric Acid Water For Injection Sodium Hydroxide Or And Hydrochloric Acid May Be Added To Adjust Ph Preservative Methylparaben 0 1 Structural Formula Structural Formula

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0756641205051
UNII
93X55PE38X U96OL57GOY
Packaging

HOW SUPPLIED: Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is supplied in a glass or plastic bottle with a controlled tip applicator in the following sizes: 5 mL fill (glass bottle) with dropper DO NOT USE IS IMPRINTED SEAL ON CAP IS BROKEN OR MISSING. KEEP OUT OF REACH OF CHILDREN FOR OPHTHALMIC USE ONLY Manufactured By: Altaire Phamacueticals, Inc. 311 West Lane Aquebogue, NY 119311 Tel: 631-722-5988; Principal Display Panel Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solutions, USP (STERILE) Rx Only 5 mL image description package insert image description iBottle Label

Package Descriptions
  • HOW SUPPLIED: Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is supplied in a glass or plastic bottle with a controlled tip applicator in the following sizes: 5 mL fill (glass bottle) with dropper DO NOT USE IS IMPRINTED SEAL ON CAP IS BROKEN OR MISSING. KEEP OUT OF REACH OF CHILDREN FOR OPHTHALMIC USE ONLY Manufactured By: Altaire Phamacueticals, Inc. 311 West Lane Aquebogue, NY 119311 Tel: 631-722-5988
  • Principal Display Panel Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solutions, USP (STERILE) Rx Only 5 mL image description package insert image description iBottle Label

Overview

Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is a sterile ophthalmic solution combining the disclosing action of Fluorescein with the anesthetic action of Proparacaine Hydrochloride. The active ingredient, Fluorescein Sodium , has the chemical name Spiro [isobenzofuran-1 (3H), 9'-[9H]xanthene]-3-one, 3' ,6' dihydroxy-,disodium salt. It is represented by the following structural formula: The active ingredient, Proparacaine Hydrochloride , has the chemical name Benzoic acid, 3-amino-4-propoxy-, 2-[diethylamino]ethyl ester monohydrochloride. It is represented by the following structural formula: EACH mL CONTAINS : ACTIVES: Fluorescein Sodium, USP, 0.25% [2.5 mg]. Proparacaine Hydrochloride, USP, 0.5% [5mg]; INACTIVES: Povidone, Boric Acid, Water for Injection, Sodium Hydroxide, or/and Hydrochloric Acid may be added to adjust pH. PRESERVATIVE: Methylparaben 0.1%. structural formula structural formula

Dosage & Administration

: Usual Dosage : Removal of foreign bodies and sutures, and for tonometry, 1 to 2 drops (in single instillations) in each eye before operating. Deep Ophthalmic Anesthesia : 1 drop in each eye every 5 to 10 minutes for 5-7 doses. NOTE : The use of an eye patch is recommended.

Warnings & Precautions
WARNINGS: Avoid contamination - do not touch tip of sterile dropper used to dispense solution to any surface. Replace container closure immediately after using. Prolonged use of a topical ocular anesthetic is not recommended. It may product permanent corneal opacification with accompanying visual loss.
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 descementitis. Allergic contact dermatitis with drying and fissuring of the fingertips has been reported. To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc. at (631) 722-5988.

Storage & Handling

STORAGE: Store in refrigerator at 2°-8°C (36°-46°F). Can be stored at room temperature for up to 1 month.


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