Drug Summary
What Is Fluress?
Fluress (fluorescein sodium and benoxinate hydrochloride) is a sterile ophthalmic solution combining a disclosing agent with an anesthetic agent used for eye 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.
What Are Side Effects of Fluress?
Fluressmay cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- changes in vision, and
- eye pain
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Fluress include:
- temporary stinging and burning in the treated eye,
- eye irritation,
- conjunctival redness,
- contact dermatitis on fingertips, and
- allergic reaction (rare).
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Fluress
The dosage of Fluress is 1 to 2 drops in each eye before operating. For deep ophthalmic anesthesia, the administration is 2 drops in each eye at 90-second intervals for 3 instillations. The use of an eye patch is recommended.
What Drugs, Substances, or Supplements Interact with Fluress?
Fluress may interact with other drugs. Tell your doctor all medications you use.
Fluress During Pregnancy or Breastfeeding
Fluress should be taken during pregnancy only if clearly needed. Consult your doctor before breastfeeding.
Additional Information
Our Fluress (fluorescein sodium and benoxinate hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Description for Fluress
Fluress® (Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP) is a sterile ophthalmic solution combining a disclosing agent with an anesthetic agent.
Fluorescein sodium is a disclosing agent with molecular formula C20H10Na2O5, molecular weight 376.28, and chemical structure:
Chemical Name:
Spiro[isobenzofuran-1(3H), 9'-[9H]xanthene]-3-one, 3'6'-dihydroxy, Disodium salt
Benoxinate Hydrochloride is an anesthetic agent with molecular formula C17H28N2O3•HCl, molecular weight 344.88, and chemical structure:
Chemical Name: Benzoic acid, 4-amino-3-butoxyl-,2-(diethylamino) ethyl ester, monohydrochloride
Each mL contains:
Active: Benoxinate Hydrochloride 4 mg (0.4%), Fluorescein Sodium 2.5 mg (0.25%).
Preservative: Chlorobutanol 10 mg (1%).
Inactive: Povidone, Boric Acid, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH), Purified Water USP.
Uses for Fluress
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.
Dosage for Fluress
Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating.
Deep ophthalmic anesthesia: 2 drops in each eye at 90 second intervals for 3 instillations.
NOTE: The use of an eye patch is recommended.
HOW SUPPLIED
Fluress (fluorescein and benoxinate) is supplied as 5 mL contained in a 10 mL plastic bottle with a separate sterile dropper applicator. (NDC 17478-640-10)
Storage
Refrigerate at 2°-8°C (36°-46°F). User may store at room temperature for up to one month. Protect from light. Keep tightly closed.
Akorn Inc., Buffalo Grove, IL 60089. Rev 5/04
Side Effects for Fluress
Occasional temporary stinging, burning and conjunctival redness have been reported after use of ocular anesthetics, as well as a rare severe, immediate-type, apparently hyperallergic corneal reaction with acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing or large areas of necrotic epithelium, corneal filaments and sometimes, iritis with descemetitis.
Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.
Drug Interactions for Fluress
No information provided.
Warnings for Fluress
NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY
Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.
Precautions for Fluress
Fluress® (Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP) 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, 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.
Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with Fluress® (fluorescein and benoxinate) . It is also not known whether Fluress® (fluorescein and benoxinate) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluress® (fluorescein and benoxinate) should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Caution should be exercised when Fluress® (fluorescein and benoxinate) is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of this product in pediatric patients has not been established.
Overdose Information for Fluress
No information provided.
Contraindications for Fluress
Known hypersensitivity to any component of this product.
Clinical Pharmacology for Fluress
Fluress® (fluorescein and benoxinate) is the combination of a disclosing agent with a rapidly acting anesthetic agent of short duration.
Patient Information for Fluress
No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.
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