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Fluorescein: Pediatric drug information

Fluorescein: Pediatric drug information
(For additional information see "Fluorescein: Drug information" and see "Fluorescein: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • AK-Fluor;
  • Bio Glo;
  • Fluor-I-Strips A.T.;
  • Fluorescite;
  • Ful-Glo [DSC];
  • GloStrips
Brand Names: Canada
  • Fluorescite;
  • Minims Fluorescein Sodium
Therapeutic Category
  • Diagnostic Agent
Dosing: Neonatal
Ophthalmic angiography for retinopathy of prematurity

Ophthalmic angiography for retinopathy of prematurity (ROP): Limited data available: PMA ≥30 weeks: IV: Usual reported dose: 10 mg/kg (0.1 mL/kg of 10% solution) as a single dose followed by a saline flush; reported range: 7.7 to 10 mg/kg/dose (Ref).

Dosing: Pediatric
Diagnostic staining

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 (Ref).

Ophthalmic angiography

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 (Ref).

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

Dosing: Kidney 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.

Dosing: Adult

(For additional information see "Fluorescein: Drug information")

Diagnostic staining

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

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 (Ref).

Dosing: Kidney 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.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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])

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: 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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous, as sodium:

Fluorescite: 10% (5 mL)

Solution, Intravenous, as sodium [preservative free]:

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

Generic: 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 [DSC]); 1 mg (100 ea [DSC])

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

Generic Equivalent Available: US

May be product dependent

Pricing: US

Solution (Fluorescite Intravenous)

10% (per mL): $12.38

Strip (Bio Glo Ophthalmic)

1 mg (per each): $0.26

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

1 mg (per each): $0.26

Strip (GloStrips Ophthalmic)

1 mg (per each): $0.15

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.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous, as sodium:

Fluorescite: 10% (5 mL)

Generic: 25% ([DSC])

Solution, Ophthalmic, as sodium:

Generic: 2% (0.3 mL)

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.

Administration: Adult

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.

Oral (off-label route): The solution for injection has been administered orally 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 to 15 minutes following oral administration (Ref).

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.

Storage/Stability

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

Ophthalmic strips: Store at controlled room temperature.

Use

Injection: Diagnostic aid in ophthalmic angiography and angioscopy of the retina and iris vasculature (AK-Fluor: FDA approved in children and adults; Fluorescite: FDA approved in pediatric patients [age not specified] and adults)

Ophthalmic: Staining of the anterior segment of the eye for diagnostic purposes (eg, ophthalmic procedures such as fitting contact lenses, disclosing corneal injury, and in applanation tonometry) (OTC: Bio Glo, Ful-Glo: Approved in adults)

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Fluorescein was found in the amniotic fluid following angiography conducted in a patient ~34 weeks' gestation (Shekleton 1980).

Outcome data following fluorescein use in pregnant patients are limited (Halperin 1990; Interlandi 2021; Lin 2012; Olk 1991).

Monitoring Parameters

Injection: Observe for signs and symptoms of hypersensitivity reactions during procedure and after; monitor injection site

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.

Pharmacokinetics (Adult Data Unless Noted)

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Fluorescein;
  • (AR) Argentina: Angiofluor | Fluoresceina | Fluorescite | Rfg-kit;
  • (AT) Austria: Fluorescein natrium | Fluorescite;
  • (AU) Australia: Fluorescein novartis | Fluoresoft | Minims fluorescein;
  • (BE) Belgium: Ak-fluor | Fluoresceine | Fluoresceine Chauvin Benelux | Fluorescine | Minims fluorescein sodium;
  • (BG) Bulgaria: Fluorescein | Fluorescite;
  • (BR) Brazil: Fludiag | Fluoresceina;
  • (CN) China: Fluorescite;
  • (CO) Colombia: BioGlo | Fluoresceina | Fluorescina sodica;
  • (CZ) Czech Republic: Fluocyne;
  • (DE) Germany: Fluorescein alcon | Fluoreszein | Fluosine;
  • (EC) Ecuador: Fluoresceina;
  • (EE) Estonia: Fluocyne | Fluorescein Se Thilo;
  • (EG) Egypt: Fluorescein | Sunnyfloresin;
  • (ES) Spain: Colircusi Fluoresceina | Fluoresceina oculos | Minims fluoresceina sodica;
  • (FI) Finland: Minims fluorescein;
  • (FR) France: Fluocyne | Fluoresceine faure | Fluorexon;
  • (GB) United Kingdom: Anatera | Fluor amps | Mf fluorescein | Retinofluor;
  • (GR) Greece: Fluocyne;
  • (HK) Hong Kong: Fluorescite | Minims fluorescein;
  • (HU) Hungary: Fluorescein | Fluorescite;
  • (ID) Indonesia: Fluorescein;
  • (IN) India: Fluresin;
  • (IT) Italy: Fluoralfa | Fluoresceina;
  • (JP) Japan: Florestin | Fluorescein kobayashi | Fluorescein sodium kobayashi | Fluorescite;
  • (KR) Korea, Republic of: Fluorecein nvr | Fluorescein | Fluorescite;
  • (KW) Kuwait: Fluorescite | Minims fluorescein sodium;
  • (LT) Lithuania: Fluorescite;
  • (LU) Luxembourg: Fluoresceine Chauvin Benelux;
  • (LV) Latvia: Fluoresceine | Fluorescite | Minims fluorescein;
  • (MA) Morocco: Fluoresceine;
  • (MX) Mexico: Fluoresceina;
  • (MY) Malaysia: Fluorescite;
  • (NL) Netherlands: Fluoresceinedinatrium;
  • (NO) Norway: Fluoresceine ciba | Fluoresceine natrium akorn | Fluoresceinnatr | Fluoresceinnatrium | Fluoresceinnatrium minims | Fluorescite;
  • (NZ) New Zealand: Fluorescein;
  • (PE) Peru: Ak-fluor | Aka fluor | Fluorescite;
  • (PK) Pakistan: Fluoroscein;
  • (PL) Poland: Ak-fluor | Fluocyne | Fluoresceine | Fluoresceine serb | Fluoresceine Thea | Fluorescite;
  • (PR) Puerto Rico: Ak-fluor | Fluorescite;
  • (PT) Portugal: Fluoresceina | Minims fluorescein sodium;
  • (QA) Qatar: Fluorescite | Minims Fluorescein Sodium;
  • (RU) Russian Federation: Fluorescein | Fluorescein novartis | Fluorescite | Flurenat;
  • (SA) Saudi Arabia: Minims fluorescein sodium;
  • (SE) Sweden: Fluoresceinnatrium chauvin | Fluorescite;
  • (SI) Slovenia: Fluorescite;
  • (TH) Thailand: Fluorescite;
  • (TN) Tunisia: Fluocyne;
  • (TR) Turkey: Fluorescein | Fluorescite | Fluoreszein | Flusible;
  • (TW) Taiwan: Fluorescein | Fluorescite;
  • (UA) Ukraine: Fluorescite;
  • (UY) Uruguay: Fluoresceina | Fluorescite;
  • (ZA) South Africa: Fluorescein | Fluorescite | Minims fluorescein sodium
  1. AK-Fluor (fluorescein injection 10% and 25%) injection [prescribing information]. Gurnee, IL: Akorn Operating Company LLC; May 2022.
  2. 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. [PubMed 18286961]
  3. BIOGLO strip (flourescein) [prescribing information]. Rancho Cucamonga, CA: HUB Pharmaceuticals, LLC; April 2012.
  4. Fluorescein GloStrips [prescribing information]. St. Louis, MO: Nomax Inc; February 2017.
  5. Fluorescite (fluorescein injection 10%) [prescribing information]. Fort Worth, Texas: Alcon Laboratories Inc; November 2021.
  6. Fluorets ophthalmic strips (flourescein) [prescribing information]. Rochester, NY: Bausch & Lomb Inc; October 2009
  7. Ful-Glo ophthalmic strips (flourescein) [prescribing information]. Lake Forest, IL: Akorn Inc; March 2012.
  8. Halperin LS, Olk RJ, Soubrane G, Coscas G. Safety of fluorescein angiography during pregnancy. Am J Ophthalmol. 1990;109(5):563-566. [PubMed 1970705]
  9. Hara T, Inami M, and Hara T. Efficacy and Safety of Fluorescein Angiography With Orally Administered Sodium Fluorescein. Am J Ophthalmol. 1998;126(4):560-564. [PubMed 9780101]
  10. Interlandi E, Pellegrini F, Silvestrin C, Pece A, Pavesio C. Hellp syndrome-related hypertensive chorioretinopathy: A multimodal imaging and optical coherence tomography angiography (OCTA) study. Eur J Ophthalmol. 2021:11206721211051238. doi:10.1177/11206721211051238 [PubMed 34636695]
  11. Kliegman RM, Stanton BMD, St. Geme J, Schor NF, eds. Nelson' s Textbook of Pediatrics. 20th ed. Saunders Elsevier; 2015.
  12. 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):33-38. [PubMed 16451256]
  13. 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]
  14. 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]
  15. Lin P, Hahn P, Fekrat S. Peripheral retinal vascular leakage demonstrated by ultra-widefield fluorescein angiography in preeclampsia with HELLP syndrome. Retina. 2012;32(8):1689-90. doi:10.1097/IAE.0b013e318261a757 [PubMed 22869028]
  16. Maquire AM, Bennett J. Fluorescein elimination in human breast milk. Arch Ophthalmol. 1988;106(6):718-719. [PubMed 3369981]
  17. Mattern J, Mayer PR. Excretion of fluorescein into breast milk. Am J Ophthalmol. 1990;109(5):598-599. [PubMed 2333925]
  18. 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]
  19. Shekleton P, Fidler J, Grimwade J. A case of benign intracranial hypertension in pregnancy. Br J Obstet Gynaecol. 1980;87(4):345-347. doi:10.1111/j.1471-0528.1980.tb04554.x [PubMed 7426506]
  20. 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]
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