ak-fluor 25%
Ak-Fluor 25% (Fluorescein Sodium) is a diagnostic dye.
Fluorescein Sodium · by Long Grove Pharms
This is one strength of Ak-Fluor 10%
The FDA label is the same for every strength in this family, so the full page — with all 2 strengths — lives on Ak-Fluor 10%.
- Ak-Fluor 10%Fluorescein Sodium EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
- Ak-Fluor 25% (this page)Fluorescein Sodium EQ 500MG BASE/2ML (EQ 250MG BASE/ML)
Key facts
- Active ingredient
- Fluorescein Sodium
- Drug class
- Diagnostic Dye
- Form
- Injectable
- Strength
- Fluorescein Sodium EQ 500MG BASE/2ML (EQ 250MG BASE/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Long Grove Pharms
- FDA application
- NDA022186
What is Ak-Fluor 25%?
From the FDA label:AK-FLUOR (fluorescein injection) contains fluorescein sodium, a diagnostic aid, in a sterile solution for use intravenously. It is a dark reddish orange clear solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt. Its molecular weight is 376.27. The active ingredient is represented by the chemical structure: AK-FLUOR (500 mg/5 mL) (100 mg/mL) 10% contains: Active ingredient: fluorescein sodium (10 % w/v, 100 mg/mL), equivalent to 88.3 mg/ml of fluorescein Inactive ingredients: sodium hydroxide and/or hydrochloric acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR 25% (500 mg/2 mL) (250 mg/mL) contains (this strength is currently not being marketed): Active ingredient: fluorescein sodium (25% w/v, 250 mg/mL), equivalent to 220.8 mg/ml of fluorescein Inactive ingredients: sodium hydroxide and/or hydrochloric acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. Chemical Structure
How to use
The normal adult dose of AK-FLUOR ® 10% is 5 mL (500 mg) via intravenous administration. ( 2.1 ) For children, the dose should be calculated on the basis of 35 mg for each 4.54 kg of body weight. (7.7 mg/kg body weight) ( 2.1 ) Do not mix or dilute with other solutions or drugs. ( 2.2 ) 2.1 Dosing Adult Dose The recommended dosage of AK-FLUOR ® 10% (100 mg/mL) is 500 mg via intravenous administration. Pediatric Dose For children, the dose is 7.7 mg/kg (actual body weight) up to a maximum of 500 mg, via intravenous infusion calculated on the basis of 35 mg for each 4.54 kg of body weight. 2.2 Preparation for Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not mix or dilute with other solutions or drugs. Discard unused portion. 2.3 Administration Inject the dose (over 5-10 seconds is normally recommended) into the antecubital vein, after taking precautions to avoid extravasation. A syringe, filled with AK-FLUOR ® , may be attached to transparent tubing and a 23 gauge butterfly needle for injection. Insert the needle and draw the patient's blood to the hub of the syringe so that a small air bubble separates the patient's blood in the tubing from the fluorescein. With the room lights on, slowly inject the blood back into the vein while watching the skin over the needle tip. If the needle has…
Side effects
The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Long Grove Pharmaceuticals, LLC at 1-855-642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 ) 6.1 Skin and urine discoloration The most common reaction is discoloration of the skin and urine. Skin will attain a temporary yellowish discoloration. Urine attains a bright yellow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours. 6.2 Gastrointestinal Reaction The next most common adverse reaction is nausea. Vomiting, and gastrointestinal distress have also occurred. A strong taste may develop after injection. 6.3 Hypersensitivity Reactions Symptoms and signs of hypersensitivity have occurred. Generalized hives and itching, bronchospasm and anaphylaxis have been reported. [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.1 ) ] 6.4 Cardiopulmonary Reactions Syncope and hypotension may occur. Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely. [see Warnings and Precautions ( 5.1 ) ] 6.5 Neurologic Reactions Headache may occur. Convulsions may rarely occur following injection. 6.6 Thrombophlebitis Thrombophlebitis at the injection site has been reported. Extravasation of the solution at the…
Warnings
Important safety information
Respiratory reactions ( 5.1 ) Severe local tissue damage ( 5.2 ) 5.1 Respiratory Reactions Caution should be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should always be available. If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein. 5.2 Severe local tissue damage Extravasation during injection can result in severe local tissue damage due to high pH of fluorescein solution. The following complications resulting from extravasation of fluorescein have been noted to occur: Sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median nerve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. When extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented. [see Administration ( 2.3 ) and Adverse Reactions ( 6.6 ) ].
Who should not take Ak-Fluor 25%
Hypersensitivity to any component of this product. ( 4.1 ) 4.1 Hypersensitivity AK-FLUOR is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )].
Drug class
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- Is there a coupon or discount for Ak-Fluor 25%?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ak-Fluor 25%. 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 Ak-Fluor 25%?
- Ak-Fluor 25% is marketed by Long Grove Pharms. You can see Long Grove Pharms's full profile, rating, and other products on pharmaranks.
- Is Ak-Fluor 25% a brand-name or generic drug?
- Ak-Fluor 25% is a brand-name product with the active ingredient Fluorescein Sodium.
- Is Ak-Fluor 25% available over the counter?
- No. Ak-Fluor 25% 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 Ak-Fluor 25% come in?
- Ak-Fluor 25% is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Ak-Fluor 25%?
- Ak-Fluor 25% is classified as diagnostic dye, per the FDA's Established Pharmacologic Class.
- Is Ak-Fluor 25% FDA-registered?
- Ak-Fluor 25% is on record with the U.S. FDA under application number NDA022186. You can verify this on its official FDA label.
- Is Ak-Fluor 25% safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Ak-Fluor 25%. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Ak-Fluor 25%?
- Ak-Fluor 25%'s side effects are taken directly from its FDA label. From the label: The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Long Grove Pharmaceuticals, LLC at 1-855-642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… 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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