AK-FLUOR 100 mg/mL
fluorescein · INJECTION · Long Grove Pharmaceuticals, LLC
AK-FLUOR is a injection containing fluorescein at 100 mg/mL, taken intravenous. Manufactured by Long Grove Pharmaceuticals, LLC.
Key Facts
- Brand Name
- AK-FLUOR
- Generic Name
- fluorescein
- NDC Code (Product)
81298-8660- Manufacturer
- Long Grove Pharmaceuticals, LLC
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA022186
- Marketing Start
- 09/28/2024
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 AK-FLUOR ® 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. AK-FLUOR is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 syrin…
Contraindications
4 CONTRAINDICATIONS 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 )].
Adverse Reactions
6 ADVERSE REACTIONS 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 ( …
Frequently Asked Questions
What is AK-FLUOR used for?
AK-FLUOR contains fluorescein. It is a injection taken intravenous. Consult your doctor for specific uses.
Is AK-FLUOR a controlled substance?
AK-FLUOR is not classified as a controlled substance by the DEA.
What is the generic name for AK-FLUOR?
The generic name for AK-FLUOR is fluorescein. There are 11 other brand versions of fluorescein.
What is the NDC code for AK-FLUOR 100 mg/mL?
The NDC (National Drug Code) for AK-FLUOR 100 mg/mL is 81298-8660, listed by Long Grove Pharmaceuticals, LLC.
Other Fluorescein Brands
See all →- C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips1 mg/mg83851-100
- Fluorescein500 mg/mL14789-122
- Dry Eye Test.12 mg/151801-008
- GloStrips1 mg/151801-009
- ALTAFLUOR4 mg/mL59390-218
- Fluorescein Sodium and Benoxinate Hydrochloride4.4 mg/mL82260-734
- Fluorescein250 mg/mL14789-123
- Fluorescein Sodium and Proparacaine Hydrochloride2.5 mg/mL59390-205
- FLUORESCITE100 mg/mL0065-0092
- GloStrips.6 mg/151801-003
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)