Altafluor

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/21/2022

Drug Summary

What Is Altafluor?

Altafluor Benox (fluorescein sodium and benoxinate hydrochloride solution) 0.25%/0.4% is used for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent.

What Are Side Effects of Altafluor?

Altafluor may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • feeling like there is something in your eye,
  • watery eyes or increased tearing eye,
  • changes in your vision,
  • stinging or burning in the eye,
  • redness of the eye, and
  • swollen eyelids

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

Side effects of Altafluor include:

  • eye redness,
  • burning,
  • stinging,
  • eye irritation,
  • blurred vision, and
  • punctate keratitis

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, lightheartedness, 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 Altafluor

Instill a dose of 1 to 2 drops of Altafluor Benox in the eye as needed.

Altafluor In Children

The safety and effectiveness of Altafluor Benox have been established for pediatric patients. Use of Altafluor Benox is supported in pediatric patients by evidence from adequate and well controlled studies.

What Drugs, Substances, or Supplements Interact with Altafluor?

Altafluor may interact with other medicines.

Tell your doctor all medications and supplements you use.

Altafluor During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Altafluor; it is unknown how it would affect a fetus. It is unknown if Altafluor passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Altafluor Benox (fluorescein sodium and benoxinate hydrochloride solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drug Description

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

Mol. Wt.= 376.27
C20H10Na2O5

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

Mol. Wt.= 344.88
C17H28N2O3 · HCl

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

EACH mL CONTAINS: ACTIVES: Fluorescein Sodium 2.5 mg (0.25%), Benoxinate Hydrochloride 4 mg (0.4%); INACTIVES: Povidone, Boric Acid, Water for Injection. Hydrochloric Acid may be added to adjust pH (4.3-5.3). PRESERVATIVE: Chlorobutanol 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 to 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: 5 mL.

Storage

Store in a refrigerator at 2°-8°C (36°-46°F), can be stored at room temperature for up to 1 month. Keep tightly closed.

FOR USE IN THE EYES ONLY.

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

KEEP OUT OF REACH OF CHILDREN

Manufactured: ALTAIRE PHARMACEUTICALS, INC. Aquebogue, NY 11931 USA. Revised: May 2014

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 sometimes, 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 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

WARNINGS

Not for Injection. Topical Use Only. 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 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 systems 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 anesthesia has worn off.

Use In Specific Populations

Pregnancy: Pregnancy Category C.

Animal reproductive studies have not been conducted with Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4%. It is also not known whether Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is administered
to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Overdose & 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.

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