Fluorescin

Pharmacologic Category

Diagnostic Agent

Dosing: Adult

Diagnostic staining: Ophthalmic: Strips: Moisten strip with sterile water, saline or ophthalmic fluid. Touch conjunctiva or fornix with tip of strip until adequately stained.

Ophthalmic angiography/angioscopy: Note: Prior to injection, an intradermal test dose of 0.05 mL may be used if an allergy is suspected. Evaluate 30-60 minutes following intradermal injection. A negative skin test does not exclude the potential for a reaction to occur.

IV: 500 mg as a single dose into antecubital vein; a dose of 200 mg may be appropriate in cases when a highly sensitive imaging system (eg, scanning laser ophthalmoscope) is used.

Oral (off-label route): 1 g of injection solution has been administered orally; clarity of photographs, particularly during early arterial phase, is reportedly poorer than photographs obtained following IV administration (Hara, 1998)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustment provided in the manufacturer's labeling.

Dosing: Pediatric

Diagnostic staining: Limited data available: Infants, Children, and Adolescents: Ophthalmic: Strips: Moisten strip with sterile water, saline, or ophthalmic fluid. Touch conjunctiva or fornix with tip of strip until adequately stained (Kliegman 2015).

Ophthalmic angiography:

Test dose: Infants, Children, and Adolescents: Intradermal: Prior to use, an intradermal test dose of 0.05 mL may be used if an allergy is suspected. Evaluate 30 to 60 minutes following intradermal injection. A negative skin test does not exclude the potential for a reaction to occur.

Diagnostic dose:

Infants: Limited data available: IV: Reported range: 7.7 to 10 mg/kg as a single dose followed by a saline flush (Azad 2008; Lepore 2011; Lepore 2014; Tahija 2013)

Children and Adolescents: IV: 7.7 mg/kg (actual body weight) as a single dose into antecubital vein; maximum dose: 500 mg/dose

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Use: Labeled Indications

Ophthalmic angiography/angioscopy (injection): Diagnostic aid in ophthalmic angiography or angioscopy of the retina and iris vasculature

Ophthalmic diagnostic staining (strips): To stain the anterior segment of the eye for procedures (such as fitting contact lenses), disclosing corneal injury, and in applanation tonometry

Administration: IV

Inject into the antecubital vein at a rate of ~1 mL/second using a 23-gauge butterfly needle attached to a small syringe. Prior to turning off room light, ensure extravasation has not occurred. Immediate treatment for anaphylaxis (including epinephrine) should be available or a test dose may be advised in some patients. Do not mix or dilute with other solutions or drugs; flush IV cannulas before and after drugs are administered. Luminescence usually appears in the retina and choroidal vessels in 7 to 14 seconds. Maintain venous access following procedure in the event treatment is needed for anaphylaxis.

Administration: Injectable Detail

pH: 8-9.8

Administration: Oral

The solution for injection has been administered orally (off-label route) in certain patients. Four grams of sugar or 1 teaspoonful of artificial sweetener may be added to decrease the bitterness of the solution. Luminescence appears in 10-15 minutes following oral administration (Hara, 1998).

Administration: Ophthalmic

Strips: Fluorescein impregnated tip should be moistened prior to application. Strip should be applied to conjunctiva or fornix. For best results, patient should blink several times after application.

Administration: Pediatric

Ophthalmic: Strips: In infants, children, and adolescents, fluorescein impregnated tip should be moistened prior to application. Strip should be applied to conjunctiva or fornix. For best results, patient should blink several times after application.

Parenteral: IV: In infants, children, and adolescents, a 23-gauge butterfly needle inserted into an antecubital vein attached to a small syringe is suggested for administration. Prior to turning off room light, steps should be taken to ensure the needle has not extravasated. Immediate treatment for anaphylaxis (including epinephrine 1 mg/mL) should be available and premedication or a test dose may be advised in some patients. Inject the dose over 5 to 10 seconds. Luminescence appears in the eye 7 to 30 seconds following injection. Maintain venous access following procedure in the event treatment is needed for anaphylaxis.

Storage/Stability

Injection: Store at controlled room temperature; protect from freezing. Protect from light.

Ophthalmic strips: Store at controlled room temperature.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used before an eye exam.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Abdominal pain

• Change in taste

• Urine discoloration

• Headache

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Vision changes

• Eye pain

• Severe eye irritation

• Severe nausea

• Vomiting

• Chest pain

• Seizures

• Passing out

• Severe injection site pain, burning, swelling, or redness

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Contraindications

Hypersensitivity to fluorescein or any other component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions may occur (death has been reported rarely); immediate treatment (including epinephrine) should be available. Serious intolerance reactions may be induced; history of adverse reaction to fluorescein or allergic reaction to foods or drugs, such as urticaria, asthma, eczema, or allergic rhinitis, may increase risk. Premedicating some patients (eg, antihistamines, corticosteroids) may be advisable. An intradermal skin test may be performed prior to use when allergy is suspected; however, a negative skin test does not rule out the potential for a reaction to occur.

• Gastrointestinal effects: Nausea and/or vomiting and gastrointestinal distress occur commonly within the first few minutes following injection; these reactions usually subside within 10 minutes.

• Skin/urine discoloration: Following use of the injection, skin may temporarily turn a yellow color within a few minutes of administration and usually fades in 6 to 12 hours. Urine may appear bright yellow for 24 to 36 hours.

Disease-related concerns:

• Allergies/asthma: Respiratory reactions may occur, especially in patients with a history of allergies or bronchial asthma; use with caution.

Special populations:

• Contact lens wearers: Ophthalmic products should not be used in patients with soft contact lenses, will cause them to discolor. Flush eyes with saline following use and wait at least 1hour prior to replacing contact lenses.

Dosage form specific issues:

• Injection: For administration via antecubital vein only; not for intrathecal or arterial injection. Avoid extravasation; severe local tissue damage may result, including skin sloughing, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. Following extravasation, severe pain may last up to several hours. Discontinue immediately if extravasation occurs.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Pregnancy outcome information is available following fluorescein use in pregnant women (Halperin 1990; Olk 1991).

Breast-Feeding Considerations

Fluorescein is excreted into breast milk when administered by injection (Maquire 1988) and ophthalmic drops (Mattern 1990). Measurable concentrations can be detected for at least 4 days following injection; pumping and discarding milk during this time period is recommended by the manufacturer.

Briggs' Drugs in Pregnancy & Lactation

• Fluorescein Sodium

Adverse Reactions

Reactions associated with use of the injection. Frequency not defined.

Cardiovascular: Arterial ischemia (basilar; rare), hypotension, shock, syncope

Central nervous system: Convulsions (rare), dizziness (Kwan 2006), headache, nerve palsy (localized; [Kwan 2006]), seizure (rare; [Kwan 2006])

Dermatologic: Pruritus, rash at injection site, skin discoloration (yellow), urticaria

Gastrointestinal: Dysgeusia, gastrointestinal distress, nausea (common), vomiting

Genitourinary: Urine discoloration (bright yellow)

Hematologic & oncologic: Hemolytic anemia (Kwan 2006), sickle cell disease (Kwan 2006, Acheson 1985)

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Local: Extravasation, inflammation at injection site

Respiratory: Bronchospasm, pulmonary edema (acute; [Kwan 2006])

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

There are no known significant interactions.

Monitoring Parameters

Injection: Hypersensitivity reactions (during procedure and after)

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as sodium:

AK-Fluor: 10% (5 mL); 25% (2 mL)

Fluorescite: 10% (5 mL)

Strip, Ophthalmic, as sodium:

Bio Glo: 1 mg (100 ea, 300 ea)

Fluor-I-Strips A.T.: 1 mg (300 ea)

Ful-Glo: 0.6 mg (300 ea); 1 mg (100 ea)

GloStrips: 1 mg (100 ea) [orange flavor]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as sodium:

Fluorescite: 10% (5 mL)

Generic: 10% (5 mL); 25% (2 mL)

Solution, Ophthalmic, as sodium:

Generic: 2% (0.3 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• S01JA01

Generic Available (US)

May be product dependent

Pricing: US

Solution (Fluorescite Intravenous)

10% (per mL): $11.57

Strip (Bio Glo Ophthalmic)

1 mg (per each): $0.23

Strip (Fluor-I-Strips A.T. Ophthalmic)

1 mg (per each): $0.26

Strip (Ful-Glo Ophthalmic)

0.6 mg (per each): $0.15

1 mg (per each): $0.19

Strip (GloStrips Ophthalmic)

1 mg (per each): $0.14

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Fluorescein sodium, a fluoresce dye, responds to wavelengths between 465-490 nm of electromagnetic radiation and light, and fluoresces at wavelengths of 520-530 nm.

Pharmacodynamics/Kinetics

Distribution: Vd: 0.5 L/kg

Metabolism: Rapidly metabolized to fluorescein monoglucuronide (~80% is metabolized 1 hour following IV administration)

Excretion: Urine; systemic clearance essentially complete 48 to 72 hours after dose

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Fluorescein Sodium; Sodium Fluorescein; Soluble Fluorescein

References

AK-Fluor (fluorescein injection 10% and 25%) [prescribing information]. Lake Forest, IL: Akorn Inc; August 2019.

Azad R, Chandra P, Khan MA, Darswal A. Role of intravenous fluorescein angiography in early detection and regression of retinopathy of prematurity. J Pediatr Ophthalmol Strabismus. 2008;45(1):36-39.

BIOGLO strip (flourescein) [prescribing information]. Rancho Cucamonga, CA: HUB Pharmaceuticals, LLC; April 2012.

Fluorescein GloStrips [prescribing information]. St. Louis, MO: Nomax Inc; February 2017.

Fluorescite (fluorescein injection 10%) [prescribing information]. Fort Worth, Texas: Alcon Laboratories, Inc; February 2016.

Fluorets ophthalmic strips (flourescein) [prescribing information]. Rochester, NY: Bausch & Lomb Incorporated. October, 2009

Ful-Glo ophthalmic strips(flourescein) [prescribing information]. Lake Forest, IL: Akorn, Inc; March 2012.

Halperin LS, Olk RJ, Soubrane G, Coscas G. Safety of fluorescein angiography during pregnancy. Am J Ophthalmol. 1990;109(5):563-566.[PubMed 1970705]

Hara T, Inami M, and Hara T. “Efficacy and Safety of Fluorescein Angiography With Orally Administered Sodium Fluorescein,” Am J Ophthalmol, 1998, 126(4):560-4.[PubMed 9780101]

Kliegman RM, Stanton BMD, St. Geme J, Schor NF, eds. Nelson' s Textbook of Pediatrics. 20th ed. Philadelphia, PA: Saunders Elsevier; 2015.

Kwan AS, Barry C, McAllister IL, et al, “Fluorescein Angiography and Adverse Drug Reactions Revisited: The Lions Eye Experience,” Clin Experiment Ophthalmol, 2006, 34(1):33-8.[PubMed 16451256]

Lepore D, Molle F, Pagliara MM. Atlas of fluorescein angiographic findings in eyes undergoing laser for retinopathy of prematurity. Ophthalmology. 2011;118(1):168-175.[PubMed 20709401 ]

Lepore D, Quinn GE, Molle F, et al. Intravitreal bevacizumab versus laser treatment in type 1 retinopathy of prematurity: report on fluorescein angiographic findings. Ophthalmology. 2014;121(11):2212-2219.[PubMed 25001158 ]

Maquire AM, Bennett J. Fluorescein elimination in human breast milk. Arch Ophthalmol. 1988;106(6):718-719.[PubMed 3369981]

Mattern J, Mayer PR. Excretion of fluorescein into breast milk. Am J Ophthalmol. 1990;109(5):598-599.[PubMed 2333925]

Olk RJ, Halperin LS, Soubrane G, Coscas G. Fluorescein angiography--is it safe to use in a pregnant patient? Eur J Ophthalmol. 1991;1(2):103-106.[PubMed 1821200]

Tahija SG, Hersetyati R, Lam GC, Kusaka S, McMenamin PG. Fluorescein angiographic observations of peripheral retinal vessel growth in infants after intravitreal injection of bevacizumab as sole therapy for zone I and posterior zone II retinopathy of prematurity. Br J Ophthalmol. 2014;98(4):507-512.[PubMed 24403566 ]

Brand Names: International

Aka-Fluor (PE); Colircusi Fluoresceina (ES); Fluocyne (FR); Fluoftal (AT); Fluor-I-Strip (NL); Fluoralfa (IT); Fluore Stain Strips (IN); Fluorescein (DE, HR); Fluoresceina (BR); Fluoresceina Oculos (ES); Fluoresceine (LU); Fluoresceine Ophtadose (BE); Fluoresceine SDU Faure (CH); Fluoresceinnatrium (SE); Fluorescite (AE, AR, AU, BF, BH, BJ, CI, CN, CY, CZ, EC, EE, EG, ET, GH, GM, GN, HK, HN, IQ, IR, JO, KE, KR, KW, LB, LR, LV, LY, MA, ML, MR, MU, MW, MY, NE, NG, NZ, OM, PL, QA, SA, SC, SD, SG, SL, SN, SY, TH, TN, TR, TW, TZ, UG, YE, ZA, ZM, ZW); Fluorets (AE, GB, HK, MT, MY, NZ, SA, ZA); Flurocin (BD); Minims Fluorescein Sodium (FI, GB); Minims Fluoresceine (BE); Ophth-fluorstrip (PK); Optifluor Diba (MX); Retinofluor (AU)

Last Updated 8/28/20