Drug Facts
Composition & Profile
Identifiers & 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
- 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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