Fluorescite (Solution) Instructions for Use

Marketing Authorization Holder

Alcon Laboratories, Inc. (USA)

Manufactured By

International Medication Systems, Ltd. (USA)

ATC Code

S01JA01 (Fluorescein)

Active Substance

Fluorescein (BAN)

Dosage Form

Fluorescite

Solution for intravenous administration 10% (500 mg/5 ml): fl. 12 pcs.

Dosage Form, Packaging, and Composition

5 ml – vials (12) – cartons.

Clinical-Pharmacological Group

Drug for fluorescent angiography and angioscopy in ophthalmology

Pharmacotherapeutic Group

Diagnostic agent

Pharmacological Action

A diagnostic agent for fluorescent angiography and angioscopy in ophthalmology. The yellow-green fluorescence of the active substance allows for the demarcation of the vascularized area from the surrounding tissues to improve visualization.

Pharmacokinetics

After intravenous administration, it is rapidly distributed throughout the body and reaches the retinal vessels within seconds. Plasma protein binding is 50-84%.

It is rapidly metabolized to fluorescein glucuronide, which also possesses fluorescent properties. Within 4-5 hours after administration, Fluorescein is detected in the blood plasma mainly in the form of glucuronide.

It is almost completely eliminated within 48 hours via bile and urine. Fluorescein is detected in the urine for 24-36 hours with a gradual decrease in its concentration; during this period, bright yellow discoloration of the urine is noted.

Indications

Diagnostic angiography or angioscopy in ophthalmology.

ICD codes

Dosage Regimen

Administer intravenously only. Use a 5 mL (500 mg) vial for a single adult dose.

Inject 2 mL to 5 mL (200 mg to 500 mg) of the 10% solution rapidly into an antecubital vein.

Ensure the injection is a bolus over approximately 5 to 10 seconds.

Perform retinal vessel visualization starting 9 to 14 seconds after injection.

Perform choroidal vessel visualization starting 9 to 14 minutes after injection.

Do not administer intra-arterially or intrathecally.

Have resuscitation equipment and personnel trained for anaphylaxis management immediately available.

Monitor the patient for at least 30 to 60 minutes post-injection for signs of hypersensitivity.

Expect bright yellow discoloration of urine and skin for 6 to 36 hours.

Adverse Reactions

Immune system disorders : hypersensitivity reactions, anaphylactic shock, anaphylactic reactions.

Nervous system disorders: acute cerebrovascular accident, loss of consciousness, syncope, convulsions, headache, dizziness, paresthesia, dysphagia, dysgeusia.

Cardiac and vascular disorders cardiac arrest, acute myocardial infarction, bradycardia, tachycardia, shock, thrombophlebitis, pronounced decrease in blood pressure, increase in blood pressure, flushing.

Respiratory, thoracic and mediastinal disorders : respiratory arrest, pulmonary edema, bronchospasm, bronchial asthma, laryngeal edema, dyspnea, cough, throat tightness, throat irritation, sneezing.

Gastrointestinal disorders: vomiting, retching, nausea, abdominal pain, constipation, diarrhea.

Skin and subcutaneous tissue disorders: dermatitis, rash, cold sweat, erythema, urticaria, pruritus, hyperhidrosis, temporary yellowish discoloration of the skin, which may appear after fluorescein administration and disappear within 6-12 hours.

Renal and urinary disorders bright yellow discoloration of urine for 24-36 hours.

Local reactions : thrombosis at the injection site (thrombophlebitis at the injection site, extravasation of the solution, with pronounced pain and possible development of necrosis of surrounding tissues),

General disorders and administration site conditions: chest pain, edema, pain, malaise, asthenia, feeling hot, chills. If the agent gets under the skin, the development of a subcutaneous granuloma and toxic ulnar neuritis is possible.

Contraindications

Hypersensitivity to fluorescein.

Clinical studies in children and adolescents under 18 years of age have not been conducted.

With caution

When used in patients with a history of allergy or bronchial asthma. When it is necessary to perform fluorescent angiography (FAG) in patients with a history of allergic reactions to the administration of angiographic dyes or other severe allergic reactions, the expected benefit of the examination should be weighed against the potential risk of developing a severe allergic reaction.

When used in patients with a history of cardiovascular diseases, diabetes mellitus, in patients receiving simultaneous therapy with several medications (especially beta-blockers); in patients with renal failure (GFR < 20 ml/min).

Use in Pregnancy and Lactation

During pregnancy, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus. If fluorescent angiography is necessary, the issue of discontinuing breastfeeding should be considered. Breastfeeding should be discontinued for 7 days after fluorescent angiography.

Use in Renal Impairment

It should be used with caution in patients with renal failure (GFR < 20 ml/min).

Pediatric Use

Clinical studies in children and adolescents under 18 years of age have not been conducted.

Geriatric Use

It should be prescribed with caution to elderly patients to avoid worsening of concomitant diseases.

Special Precautions

Intrathecal or intra-arterial administration is contraindicated. The agent is intended only for intravenous administration and diagnostic procedures in ophthalmology.

Before using fluorescein, a complete medical history, including an allergy history, should be carefully collected; it is necessary to clarify the use of medications (especially beta-blockers, including eye drops) and the presence of a history of cardiovascular diseases.

Fluorescein may affect the results of some blood and urine laboratory tests for 3-4 days. An effect of fluorescein on the results of determining digoxin and cortisol in blood serum has been noted.

Caution should be exercised when conducting therapeutic drug monitoring of drugs with a narrow therapeutic index (e.g., digoxin, quinidine).

X-ray examinations are not recommended for 36 hours after fluorescein administration, as the obtained results may be distorted.

Effect on ability to drive vehicles and operate machinery

After fluorescein administration, patients should avoid driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions until normal visual activity is restored.

Drug Interactions

Concomitant use of fluorescein with beta-blockers (including ophthalmic drop solutions) may, in rare cases, provoke the development of severe anaphylactic reactions. Beta-blockers may suppress the development of compensatory vascular reactions in the event of anaphylactic shock and reduce the effectiveness of epinephrine preparations in cardiovascular failure.

Simultaneous intravenous administration of other drugs or mixing of the fluorescein sodium solution with other solutions should be avoided, as the possibility of drug interaction cannot be excluded.

Caution should be exercised when conducting therapeutic drug monitoring of drugs with a narrow therapeutic index (e.g., digoxin, quinidine).

The fluorescein solution should not be mixed with other medicinal products.

In solutions of medicinal products with acidic pH (especially antihistamines, e.g., promethazine) or upon interaction with citric acid, precipitation of fluorescein sodium occurs.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.