Fluorescite Fluorescein Sodium Injection

1. Indications and Usage
Fluorescein Sodium Injection is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
2. Dosage and Administration
Route: Intravenous administration.
Adult Dose: 500 mg administered intravenously. This may be given as 5 mL of Fluorescein Injection 10% (100 mg/mL) or 2 mL of Fluorescein Injection 25% (250 mg/mL).
Pediatric Dose: 7.7 mg/kg (35 mg per 10 lb) of actual body weight, up to a maximum of 500 mg.
Administration: Administer into the antecubital vein, typically over 5–10 seconds, with precautions to avoid extravasation.
Preparation: Do not mix or dilute with other solutions or drugs. Inspect visually for particulate matter and discoloration prior to administration.
3. Mechanism of Action
Fluorescein sodium responds to electromagnetic radiation and light between wavelengths of 465–490 nm and fluoresces, emitting light at wavelengths of 520–530 nm. After intravenous injection, the unbound fraction circulates through the ocular vasculature and emits yellowish-green fluorescence under blue light excitation, allowing visualization of retinal and choroidal vessels during fluorescein angiography.
4. Safety and Warnings
Hypersensitivity/Anaphylaxis: Contraindicated in patients with known hypersensitivity to fluorescein sodium or any component. Rare cases of death due to anaphylaxis have been reported.
Respiratory Reactions: Caution in patients with a history of allergy or bronchial asthma. An emergency tray should be available.
Severe Local Tissue Damage: Extravasation during injection can cause severe local tissue damage.
Nausea/Vomiting: Nausea and/or vomiting may occur within minutes following injection.
Pregnancy and Lactation: Adequate animal reproduction studies have not been conducted. Caution should be exercised when administered to a nursing woman.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Skin discoloration (temporary yellowish discoloration), urine discoloration (bright yellow/orange), nausea, vomiting, and gastrointestinal distress.
Other Reported Reactions: Headache, fainting, hypotension, hypersensitivity reactions (urticaria, itching, bronchospasm, anaphylaxis), cardiac arrest, shock, convulsions, and injection site reactions.
Clinical Research: Clinical experience supports its use as a diagnostic aid in fluorescein angiography, with most adverse reactions being transient and self-limiting.
6. Drug Interactions
No formal drug interaction studies have been conducted. Fluorescein sodium should not be mixed or diluted with other solutions or drugs.
7. Pharmaceutical Information
Active Ingredient: Fluorescein sodium.
Chemical Name: spiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one, 3′,6′-dihydroxy, disodium salt.
Strengths:
Fluorescein Injection 10%: 100 mg/mL (500 mg/5 mL single-dose vial).
Fluorescein Injection 25%: 250 mg/mL (500 mg/2 mL single-dose vial).
Description: Sterile, unpreserved aqueous solution; dark reddish orange in color; pH 8.0–9.8; osmolality 572–858 mOsm/kg.
Inactive Ingredients: Sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.
Storage: Store at controlled room temperature. Protect from light. Do not freeze.