Flurox

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 2/22/2022
Drug Description

What is Flurox and how is it used?

Flurox is a prescription medicine used as Deep Ophthalmic Anesthesia for short corneal and conjunctival procedures. Flurox may be used alone or with other medications.

Flurox belongs to a class of drugs called Anesthetics, Ophthalmic; Diagnostics, Ophthalmics.

It is not known if Flurox is safe and effective in children.

What are the possible side effects of Flurox?

Flurox may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • eye redness,
  • eye pain,
  • excess tears or discharge from the eye,
  • difficulty opening your eyelid due to pain or irritation,
  • blurred vision,
  • decreased vision,
  • sensitivity to lights,
  • feeling as if something is in your eye,
  • gray or ground glass appearance of the eye,
  • extreme sensitivity to light,
  • corneal scarring,
  • dark floating spots in the field of vision, and
  • drying or cracking skin on the fingertips

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Flurox include:

  • temporary stinging,
  • burning, and
  • eye redness

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Flurox. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For Use in the Eyes Only

DESCRIPTION

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:

Fluorescein sodium Structural Formula Illustration

Chemical Name: Spiro [isobenzofuran-1 (3H), 9 -[9H] xanthene]-3-one, 3’,6’ dihydroxy, disodium salt.

Benoxinate Hydrochloride is represented by the following structural formula:

Benoxinate Hydrochloride Structural Formula Illustration

Chemical Name: 2-(Diethylamino) ethyl 4-amino-3butoxybenzoate monohydrochloride

EACH mL CONTAINS: ACTIVES: Fluorescein Sodium 2.5mg (0.25%), Benoxinate Hydrochloride 4mg (0.4%)
INACTIVES: Povidone, Boric Acid, Water For Injection. Hydrochloric Acid may be added to adjust pH (4.3 - 5.3).
PRESERVATIVE: Methylparaben 0.1%.

Indications & Dosage

INDICATIONS

For procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.

DOSAGE AND ADMINISTRATION

Usual Dosage

Removal of foreign bodies and sutures, and for tonometry, 1 or 2 drops (in single instillations) in each eye before operating.

HOW SUPPLIED

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is supplied in a glass bottle with a sterilized dropper in the following size: 5mL

Storage & Handling

Store in a refrigerator at 2°-8°C (36°-46°F). Can be stored at room temperature for up to one month. Keep tightly closed.

DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR MISSING.

KEEP OUT OF REACH OF CHILDREN

Manufactured: OCuSOFT, Inc. Richmond, TX 77406-0429. Revised: Nov 2019

QUESTION

What causes dry eyes? See Answer
Side Effects & Drug Interactions

SIDE EFFECTS

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 someimes, iritis with descemetitis.

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.

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

WARNINGS

Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss. Avoid contamination - do not touch tip of sterile dropper used to dispense solution to any surface. Replace container closure immediately after using.

PRECAUTIONS

This product should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. The long-term toxicity is unknow; prolonged use may possible delay woundhealing.
Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity manifested by central nervous sytem stimulation followed by depression may occur. Protection of the eye from irritation, 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 anesthsia has worn off.

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

Known hypersensitivity to any component of this product.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

This product is the combination of a disclosing agent with a rapidly acting anesthetic of short duration.

Medication Guide

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

FDA Logo

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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