altafluor benox
Pharmaranks rates Altafluor Benox 3.1/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Altafluor Benox is a combination medicine containing Benoxinate Hydrochloride and Fluorescein Sodium.
Benoxinate Hydrochloride and Fluorescein Sodium · by Altaire Pharms Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Benoxinate Hydrochloride and Fluorescein Sodium
- Form
- Solution
- Strength
- Benoxinate Hydrochloride 0.4%; Fluorescein Sodium 0.25%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Altaire Pharms Inc
- FDA application
- NDA208582
What is Altafluor Benox?
From the FDA label:Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a sterile disclosing agent in combination with a short-acting ester anesthetic for topical ophthalmic use. Fluorescein sodium is represented by the following structural formula: C 20 H 10 Na 2 O 5 Mol. Wt. 376.27 Chemical Name: Spiro [isobenzofuran-1 (3 H ),9’-9[9 H ] xanthene]-3-one, 3’,6’ dihydroxy, disodium salt. Benoxinate hydrochloride is represented by the following structural formula: C 17 H 28 N 2 O 3 • HCl Mol. Wt. 344.88 Chemical Name: 2-(Diethylamino) etyl 4-amino-3-butoxybenzoate monohydrochloride. Each mL contains: Actives: fluorescein sodium 2.5 mg (0.25%) equivalent to fluorescein 2.2 mg (0.22%), benoxinate hydrochloride 4 mg (0.4%) equivalent to benoxinate 3.6 mg (0.36%); Inactives: povidone, hydrochloric acid, boric acid, sodium hydroxide, water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.3 – 5.3). Preservative: chlorobutanol 11mg (1.1%). 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. Benoxinate Hydrochloride is represented by the following structural formula:
How to use
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 )
Side effects
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.
Warnings
Important safety information
Corneal toxicity: Prolonged use or abuse may lead to corneal epithelial toxicity and manifest as epithelial defects which may progress to permanent corneal damage. ( 5.1 ) Corneal injury: Patients should not touch the eye for approximately 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. ( 5.2 ) 5.1 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. 5.2 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.
Who should not take Altafluor Benox
Altafluor Benox is contraindicated in patients with known hypersensitivity to any component of this product. Known hypersensitivity to any component of this product. ( 4 )
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- How is Altafluor Benox rated?
- pharmaranks gives Altafluor Benox a composite score of 3.1 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Altafluor Benox?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Altafluor Benox. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Altafluor Benox?
- Altafluor Benox is marketed by Altaire Pharms Inc. You can see Altaire Pharms Inc's full profile, rating, and other products on pharmaranks.
- Is Altafluor Benox a brand-name or generic drug?
- Altafluor Benox is a brand-name product with the active ingredient Benoxinate Hydrochloride and Fluorescein Sodium.
- Is Altafluor Benox available over the counter?
- No. Altafluor Benox is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Altafluor Benox come in?
- Altafluor Benox is currently marketed as solution, per the FDA's National Drug Code Directory.
- Is Altafluor Benox FDA-registered?
- Altafluor Benox is on record with the U.S. FDA under application number NDA208582. You can verify this on its official FDA label.
- Has Altafluor Benox been recalled by the FDA?
- Altafluor Benox has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Altafluor Benox safe?
- There's no single safe-or-not verdict. pharmaranks gives Altafluor Benox a recall-safety score of 62/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Altafluor Benox?
- Altafluor Benox's side effects are taken directly from its FDA label. From the label: 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… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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altafluor benox
62/100