Drugplain

FLUORESCEIN 100 mg/mL

FLUORESCEIN · INJECTION · HF Acquisition Co LLC, DBA HealthFirst

No Recall History
Plain English

FLUORESCEIN is a injection containing fluorescein at 100 mg/mL, taken intravenous. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.

Key Facts

Brand Name
FLUORESCEIN
Generic Name
FLUORESCEIN
NDC Code (Product)
51662-1533
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Strength
100 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA022186
Marketing Start
05/10/2021

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1. INDICATIONS & USAGE Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. Fluorescein Injection, USP is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. ( 1 )

Dosage & Administration

2. DOSAGE & ADMINISTRATION The normal adult dose of Fluorescein Injection 10%, is 5 mL (500 mg) and of Fluorescein Injection 25%, is 2 mL (500 mg) via intravenous administration. ( 2.1 ) For children, the dose should be calculated on the basis of 35 mg for each ten pounds of body weight (7.7 mg/kg body weight). ( 2.2 ) Do not mix or dilute with other solutions or drugs. ( 2.2 ) 2.1 Dosing Adult Dose The recommended dosage of Fluorescein Injection 10% (100 mg/mL) and of Fluorescein Injection 25% (250 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 10 lbs. (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, fi led with Fluorescein, may be attached to trans…

Contraindications

4. CONTRAINDICATIONS Hypersensitivity to any component of this product. ( 4.1 ) 4.1 Hypersensitivity Fluorescein Injection, USP 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 Lambda Therapeutics Limited at 1-855-642-2594or email: safety.nexuspharma@lambda-cro.com 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 ye lowish discoloration. Urine attains a bright ye llow 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…

Frequently Asked Questions

What is FLUORESCEIN used for?

FLUORESCEIN contains FLUORESCEIN. It is a injection taken intravenous. Consult your doctor for specific uses.

Is FLUORESCEIN a controlled substance?

FLUORESCEIN is not classified as a controlled substance by the DEA.

What is the generic name for FLUORESCEIN?

The generic name for FLUORESCEIN is FLUORESCEIN. There are 11 other brand versions of FLUORESCEIN.

What is the NDC code for FLUORESCEIN 100 mg/mL?

The NDC (National Drug Code) for FLUORESCEIN 100 mg/mL is 51662-1533, listed by HF Acquisition Co LLC, DBA HealthFirst.

Product NDC

51662-1533

Package NDC

51662-1533-3

Other Fluorescein Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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