Altafluor Drug Information
Generic name: FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE
Uses of Altafluor
Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a combination disclosing agent and local ester anesthetic indicated for procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic.
Dosage & Administration of Altafluor
Instill 1 to 2 drops of Altafluor Benox in the eye as needed. Instill 1 to 2 drops topically in the eye as needed to achieve adequate anesthesia.
Side Effects of Altafluor
The following ocular adverse reactions are described elsewhere in the labeling: Corneal Toxicity Corneal Injury due to Insensitivity The following adverse reactions have been identified following use of fluorescein sodium and benoxinate hydrochloride ophthalmic solution 0.25% / 0.4%: ocular hyperemia, burning, stinging, eye irritation, blurred vision and punctate keratitis. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common ocular adverse events are: stinging, burning and conjunctival redness.
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.
Warnings & Cautions for Altafluor
Corneal Toxicity Prolonged use or abuse may lead to corneal epithelial toxicity
which may manifest as epithelial defects and progress to permanent corneal opacification with accompanying visual loss.
Corneal Injury Due to Insensitivity Patient should not touch the eye for
approximately 20 minutes after using this anesthetic as accidental injuries can occur due to insensitivity of the eye.
Pregnancy Safety for Altafluor
Pregnancy Risk Summary There are no available data on the use of Altafluor Benox in pregnant women to inform any drug associated risk. Adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. Altafluor Benox should be given to a pregnant woman only if clearly needed.
Pediatric Use of Altafluor
Pediatric Use 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.
Contraindications for Altafluor
CONTRAINDICATIONS: Altafluor Benox is contraindicated in patients with known hypersensitivity to any component of this product. Known hypersensitivity to any component of this product.
Clinical Studies of Altafluor
Controlled clinical studies in adults and pediatric patients have demonstrated that topical administration of fluorescein sodium and benoxinate hydrochloride ophthalmic solution 0.25%/0.4% enables visualization and corneal anesthesia sufficient to enable applanation tonometry, tear fluid dynamics evaluation and short conjunctival and corneal procedures. Maximal corneal anesthesia usually occurs in about 5-45 seconds and lasts about 20 minutes after single administration.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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