DailyMed Label: Fluorescein Sodium and Proparacaine Hydrochloride

DailyMed Label: Fluorescein Sodium and Proparacaine Hydrochloride

2022

DailyMed Prescription

Fluorescein Sodium and Proparacaine Hydrochloride

Fluorescein Sodium and Proparacaine Hydrochloride

Altaire Pharmaceuticals Inc.

NDC: 59390-205

NDC: 59390-205

NDC: 59390-205

NDC: 59390-205

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

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.

This product 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 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.

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.

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

This product is the combination of a disclosing agent with a rapidly acting anesthetic of short duration. For procedures requiring a disclosing agent in combination with an anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.

Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solutions, USP (STERILE) Rx Only 5 mL image description package insert image description iBottle Label