Fluorescein sodium

Fluorescein sodium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Overview

Fluorescein sodium is a disclosing agent that is FDA approved for the procedure of fluorescein angiography or angioscopy of the retina and iris vasculature. Common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting and gastrointestinal distress.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Fluorescein sodium is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

• Dosage: 500 mg via intravenous administration.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Fluorescein sodium in adult patients.

Non–Guideline-Supported Use

• Diagnosis of blocked lacrimal canaliculus
• Diagnosis of cerebrospinal fluid rhinorrhea
• Extraction of cataract
• Scanning or imaging with vascular flow
• Torsion of the ovary, ovarian pedicle or fallopian tube

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Fluorescein sodium is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

• Dosage: 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.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Fluorescein sodium in pediatric patients.

Non–Guideline-Supported Use

• Diagnosis of blocked lacrimal canaliculus

Contraindications

• 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.

Warnings

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.

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.

Adverse Reactions

Clinical Trials Experience

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.

Gastrointestinal Reaction

• The next most common adverse reaction is nausea.
• Vomiting, and gastrointestinal distress have also occurred.
• A strong taste may develop after injection.

Hypersensitivity Reactions

• Symptoms and signs of hypersensitivity have occurred.
• Generalized hives and itching, bronchospasm and anaphylaxis have been reported.

Cardiopulmonary Reactions

• Syncope and hypotension may occur.
• Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely.

Neurologic Reactions

• Headache may occur
• Convulsions may rarely occur following injection.

Thrombophlebitis

• Thrombophlebitis at the injection site has been reported.
• Extravasation of the solution at the injection site causes intense pain at the site and a dull aching pain in the injected arm.

Postmarketing Experience

There is limited information regarding Fluorescein sodium Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Fluorescein sodium Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. Fluorescein sodium should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluorescein sodium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fluorescein sodium during labor and delivery.

Nursing Mothers

Fluorescein sodium has been demonstrated to be excreted in human milk. Caution should be exercised when fluorescein sodium is administered to a nursing woman.

Pediatric Use

Pediatric patients have been included in clinical studies. No overall differences in safety or effectiveness have been observed between pediatric and adult patients.

Geriatic Use

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Gender

There is no FDA guidance on the use of Fluorescein sodium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fluorescein sodium with respect to specific racial populations.

Renal Impairment

A renal clearance of 1.75 mL/min/kg have been estimated.

Hepatic Impairment

A hepatic clearance (due to conjugation) of 1.50 mL/min/kg have been estimated.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fluorescein sodium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fluorescein sodium in patients who are immunocompromised.

Administration and Monitoring

Administration

Intravenous

Monitoring

There is limited information regarding Fluorescein sodium Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Fluorescein sodium and IV administrations.

Overdosage

There is limited information regarding Fluorescein sodium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Fluorescein sodium
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Mechanism of Action

Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465 to 490 nm and fluoresces, i.e., emits light at wavelengths of 520 to 530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish green. Following intravenous injection of fluorescein sodium in an aqueous solution, the unbound fraction of the fluorescein can be excited with a blue light flash from a fundus camera as it circulates through the ocular vasculature, and the yellowish green fluorescence of the dye is captured by the camera. In the fundus, the fluorescence of the dye demarcates the retinal and/or choroidal vasculature under observation, distinguishing it from adjacent areas/structures.

Structure

Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure:

Pharmacodynamics

There is limited information regarding Fluorescein sodium Pharmacodynamics in the drug label.

Pharmacokinetics

Distribution

Within 7 to 14 seconds after IV administration into the antecubital vein, fluorescein usually appears in the central retinal artery of the eye. Within a few minutes of IV administration of fluorescein sodium, a yellowish discoloration of the skin occurs, which begins to fade 6 to 12 hours after dosing. Various estimates of volume of distribution indicate that fluorescein distributes into interstitial space (0.5 L/kg).

Metabolism

Fluorescein is metabolized to fluorescein monoglucuronide. After IV administration of fluorescein sodium (14 mg/kg) to 7 healthy subjects, approximately 80% of fluorescein in plasma was converted to glucuronide conjugate after a period of 1 hour post dose.

Excretion

Fluorescein and its metabolite are mainly eliminated via renal excretion. After IV administration, the urine remains slightly fluorescent for 24 to 36 hours. A renal clearance of 1.75 mL/min/kg and a hepatic clearance (due to conjugation) of 1.50 mL/min/kg have been estimated. The systemic clearance of fluorescein was essentially complete by 48 to 72 hours after administration of 500 mg fluorescein.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis

There have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.

Clinical Studies

There is limited information regarding Fluorescein sodium Clinical Studies in the drug label.

How Supplied

• Fluorescein injection 10%

• 100 mg/mL in a 5 mL
• NDC 17478-253-10
• Single dose vials in a package of 12

• Fluorescein injection 25%

• 250 mg/mL in a 2 mL
• NDC 17478-250-20
• Single dose vials in a package of 12

Storage

• Should be stored at 20° to 25°C (68° to 77°F).
• Do not freeze.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

After administration of fluorescein sodium, 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.

Precautions with Alcohol

Alcohol-Fluorescein sodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• AK-Fluor
• Angioscein
• Fluor-I-Strip
• Fluor-I-Strip A.T.
• Fluorescite
• Fluorets
• Ful-Glo
• Ocu-Flur 10

Look-Alike Drug Names

There is limited information regarding Fluorescein sodium Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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