Fluorescein Sodium and Proparacaine Hydrochloride
Solution/ Drops · Ophthalmic
Dosage and administration
DOSAGE AND 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
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.
Precautions
PRECAUTIONS: 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.
Side effects
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.
Description
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, 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
How supplied
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
Storage
STORAGE: Store in refrigerator at 2°-8°C (36°-46°F). Can be stored at room temperature for up to 1 month.
Label text from the FDA structured product label by Altaire Pharmaceuticals Inc. (revised Oct 28, 2022). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Fluorescein Sodium in 1 product
- Proparacaine Hydrochloride in 1 product
Fluorescein Sodium and Proparacaine Hydrochloride NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 59390-205 | Fluorescein Sodium 2.5 mg/mL; Proparacaine Hydrochloride 5 mg/mL Solution/ Drops | Altaire Pharmaceuticals Inc. | UNAPPROVED DRUG OTHER |
Fluorescein Sodium and Proparacaine Hydrochloride recalls
- D-0422-2020 Nov 27, 2019 · Class II · Completed
Lack of Assurance of Sterility
Frequently asked questions
What are the side effects of Fluorescein Sodium and Proparacaine Hydrochloride?
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… See the full label for the complete list.
Who makes Fluorescein Sodium and Proparacaine Hydrochloride?
Fluorescein Sodium and Proparacaine Hydrochloride is listed by 1 labeler in the FDA NDC directory, including Altaire Pharmaceuticals Inc..
Has Fluorescein Sodium and Proparacaine Hydrochloride been recalled?
The FDA enforcement database lists 1 recall for Fluorescein Sodium and Proparacaine Hydrochloride, most recently D-0422-2020 (class ii): Lack of Assurance of Sterility