ALTAFLUOR 4 mg/mL
Fluorescein Sodium and Benoxinate Hydrochloride · SOLUTION · Altaire Pharmaceuticals Inc.
ALTAFLUOR is a solution containing fluorescein sodium and benoxinate hydrochloride at 4 mg/mL, taken ophthalmic. Manufactured by Altaire Pharmaceuticals Inc..
Key Facts
- Brand Name
- ALTAFLUOR
- Generic Name
- Fluorescein Sodium and Benoxinate Hydrochloride
- NDC Code (Product)
59390-218- Manufacturer
- Altaire Pharmaceuticals Inc.
- Strength
- 4 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA208582
- Marketing Start
- 03/01/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. ( 2 )
Contraindications
4 CONTRAINDICATIONS: Altafluor Benox is contraindicated in patients with known hypersensitivity to any component of this product. Known hypersensitivity to any component of this product. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following ocular adverse reactions are described elsewhere in the labeling: Corneal Toxicity [ see Warnings and Precautions (5.1) ] Corneal Injury due to Insensitivity [ see Warnings and Precautions (5.2) ] 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. ( 6 ) 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.
Frequently Asked Questions
What is ALTAFLUOR used for?
ALTAFLUOR contains Fluorescein Sodium and Benoxinate Hydrochloride. It is a solution taken ophthalmic. Consult your doctor for specific uses.
Is ALTAFLUOR a controlled substance?
ALTAFLUOR is not classified as a controlled substance by the DEA.
What is the generic name for ALTAFLUOR?
The generic name for ALTAFLUOR is Fluorescein Sodium and Benoxinate Hydrochloride. There are 2 other brand versions of Fluorescein Sodium and Benoxinate Hydrochloride.
What is the NDC code for ALTAFLUOR 4 mg/mL?
The NDC (National Drug Code) for ALTAFLUOR 4 mg/mL is 59390-218, listed by Altaire Pharmaceuticals Inc..