Fluorescein sodium - instructions for use, dose, side effects, contraindications

Active substanceFluorescein sodiumFluorescein sodium

Similar drugsTo uncover

Fluorescein sodium

solution in / in

SSC NIOPIK, FSUE Russia

Fluorescein Novartis

solution in / in

Novartis Pharma AG Switzerland

Fluorescence ®

solution in / in

Alcon Laboratories Inc. USA

Dosage form: & nbspRAsterol for intravenous administration.

Composition:

1 bottle contains:

active substance: fluorescein sodium - 0.50 g;

Excipients: sodium hydroxide - up to pH 8.0-9.8 water for injection - up to 5.0 ml

Description:Transparent, dark orange solution.

Pharmacotherapeutic group:diagnostic tool

ATX: & nbsp

S.01.J.A.01 Fluorescein

Pharmacodynamics:

A solution of sodium fluorescein is a diagnostic dye. When fluorescein sodium is stimulated with blue light (absorption from 465 nm to 490 nm), a yellow-green fluorescence with a wavelength of 520 nm to 530 nm is observed. The method of fluorescent angiography of the fundus allows to diagnose circulatory disorders of the retina.

Pharmacokinetics:

Distribution

After intravenous fluorescein sodium administration is rapidly distributed in the body and reaches the retinal vessels in a few seconds.

Binding to blood plasma proteins

In the blood plasma 50-84% sodium fluorescein binds to proteins (especially albumin) and about 15-17% - to red blood cells.

After the administration of fluorescein sodium, the patient's skin temporarily acquires a yellowish hue, disappearing after 6-12 hours.

Metabolism

In the body, the drug is rapidly metabolized to fluorescein glucuronide, which also has fluorescent properties. After 4-5 hours after administration, the drug is detected in the blood plasma, mainly in the form of glucuronide. The glucuronic metabolite binds less to plasma proteins than sodium fluorescein.

Excretion

The final half-life of fluorescein sodium and its glucuronic metabolite from plasma is approximately 23.5 and 264 minutes, respectively.

In 48 hours almost complete (by 90%) elimination of sodium fluorescein and its metabolites with bile and urine occurs. The drug is determined in the urine within 24-36 hours with a gradual decrease in its concentration. Within 24-36 hours after the administration of sodium fluorescein, a bright yellow staining of urine is observed.

In patients with diabetes, the pharmacokinetic parameters of sodium fluorescein do not change.

In patients with renal insufficiency(GFR <20 mL / min), administration of the preparation is slow.

Indications:

Fluorescence angiography of the eye day and the vascular bed of the iris. The drug is intended only for diagnostic purposes.

Contraindications:

- Hypersensitivity to sodium fluorescein or any other component of the drug;

- intrathecal or intra-arterial administration.

Clinical studies on the use of fluorescein sodium solution in children and adolescents under the age of 18 have not been conducted.

Carefully:

Care should be taken when using the drug in patients with an allergy or bronchial asthma in the anamnesis. If it is necessary to perform fluorescent angiography (PHAG) in patients with allergic reactions in the history of administration of anti- ographic dyes or other severe allergic reactions in the anamnesis, the expected benefit from the study and the potential risk of developing a severe allergic reaction should be correlated.

Care should be taken when using the drug in patients with a history of cardiovascular disease, diabetes mellitus, in patients receiving concomitant therapy with several drugs (especially beta-adrenoblockers); as well as in patients with renal insufficiency (GFR <20 mL / min).

Pregnancy and lactation:

Studies of fluorescein sodium in animals have not revealed teratogenic effects.

The potential risk to the fetus during PHAG in pregnant women is unknown.

The drug should not be used during pregnancy, except when the expected benefit from the study for the mother exceeds the potential risk to the fetus.

Fluorescein sodium is excreted in breast milk and is determined therein up to 7 days after drug administration. Should be abandoned breastfeeding within 7 days after the FAG. For complete removal of the drug from breast milk, it may take about two weeks after intravenous administration.

Dosing and Administration:

Adults

5 ml of the drug (1 bottle) is injected intravenously.

Patients ≥65 years of age

Older patients do not need to adjust the dosage regimen of the drug.

Patients ≤ 18 years of age

Clinical studies on the use of sodium fluorescein in children and adolescents under the age of 18 have not been conducted. In this category of patients, the drug is recommended for administration, for example, 5 mg / kg.

Patients with impaired renal function

The experience of using fluorescein sodium preparations in patients with renal insufficiency (GFR <20 ml / min) is limited.In these patients, slow withdrawal of the drug; for patients on hemodialysis, a dose reduction of up to 2.5 ml is necessary.

Patients with impaired hepatic function

Clinical studies on the use of fluorescein sodium preparations in patients with hepatic insufficiency have not been conducted. There are no data on the need for dose adjustment in this category of patients.

Side effects:

Data on the following adverse events (AEs) without determining the frequency of occurrence were obtained as a result of the postmarketing period of application of fluorescein sodium preparations. AEs are grouped according to the organ classification Med-DRA and listed in order of decreasing importance.

The most common adverse reactions with sodium fluorescein drugs are nausea and vomiting.

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

Impaired nervous system: acute disturbance of cerebral circulation, loss of consciousness, fainting, convulsions, headache, dizziness, paresthesia, dysphagia, dysgeusia.

Heart Disease: cardiac arrest, acute myocardial infarction, bradycardia, tachycardia.

Vascular disorders: shock, thrombophlebitis, marked decrease in blood pressure, increased blood pressure, "hot flashes".

Disturbances from the respiratory system, chest and mediastinal organs: respiratory depression, pulmonary edema, bronchospasm, bronchial asthma, laryngeal edema, dyspnea, cough, a feeling of "tightness" in the throat, irritation in the throat, sneezing.

Disorders from the gastrointestinal tract: vomiting, urge to vomit, nausea, abdominal pain, constipation, diarrhea.

Disturbances from the skin and subcutaneous tissues: dermatitis, rash, cold sweat, erythema, urticaria, pruritus, hyperhidrosis, temporary yellowish staining of the skin, which can appear after the administration of the drug and disappear within 6-12 hours.

Disorders from the kidneys and urinary tractth: chromaturia (bright yellow color of urine within 24-36 hours).

General disorders and disorders at the site of administration: thrombosis at the injection site (thrombophlebitis at the injection site, extravasation of the drug solution, with severe pain and possible development of necrosis of surrounding tissues), chest pain, swelling, pain, deterioration in overall health, asthenia, heat, chills.If the product gets under the skin, subcutaneous granuloma and toxic ulnar nerve ulcers may develop.

Overdose:

Data on drug overdose are absent.

Interaction:

Simultaneous use of the drug with beta-adrenoblockers (including solutions of eye drops) can in rare cases provoke the development of severe anaphylactic reactions. Beta-adrenoblockers can suppress the development of compensatory vascular reactions in the event of anaphylactic shock and reduce the effectiveness of epinephrine preparations for cardiovascular failure.

You should avoid simultaneous intravenous administration of other drugs or mixing fluorescein sodium solution with other solutions, since it is impossible to exclude the possibility of drug interaction.

There have been reports of a possible development of drug interaction with the simultaneous use of the drug with some inhibitors of the transport of organic anions, as well as the possible effect of the drug on the results of some laboratory studies.The drug may affect the results of laboratory tests of blood and urine for 3-4 days.

Caution should be exercised in the therapeutic monitoring of the concentration of drugs with a narrow therapeutic index (for example, digoxin, quinidine).

Incompatibility

The drug should not be mixed with other drugs.

In the drug solution with an acidic pH (especially antihistamines, e.g., promethazine), or by reaction with citric acid, the precipitation of sodium fluorescein. Medicines with acidic pH should not be administered concomitantly with the drug through a common system for intravenous administration.

Special instructions:

Before conducting the PHAG, you should carefully collect a complete medical history, including allergic; it is necessary to clarify the use of drugs (especially beta-blockers, including eye drops) and the presence of a history of cardiovascular disease.

Fluorescein sodium can cause the development of severe allergic reactions. The development of such reactions is always unpredictable, but, as a rule, they are more often developed in patients,(in addition to symptoms such as nausea and vomiting), in patients with a food allergy in the history (in the form of bronchial asthma, eczema, allergic rhinitis, urticaria), as well as in patients with bronchial asthma in the anamnesis.

Results of intradermal tests have limited prognostic value, the development of allergic reactions is possible and with a negative result of intradermal tests.

In connection with the risk of developing hypersensitivity reactions during PHAG, the following precautions should be observed: close monitoring of the ophthalmologist conducting the study, both during the procedure and within 30 minutes after its completion; preservation of intravenous access for a minimum of 5 minutes after the administration of the drug for the purpose of urgent medical measures in case of serious adverse reactions; in the room for the study should be in advance to prepare the appropriate equipment and medicines needed for emergency resuscitation, including, first of all,providing additional intravenous access to restore the volume of blood plasma with the use of water-salt and colloidal plasma-substitution solutions, as well as intravenous epinephrine in appropriate doses.

There have been cases of development of severe complications from the cardiovascular system, such as chest pain, myocardial infarction and shock after the administration of sodium fluorescein.

Patients with a history of cardiovascular disease, diabetes, as well as patients receiving concomitant therapy with several drugs (especially beta-blockers) should evaluate the ratio of the expected benefit of the drug to the possible risk before using the drug.

In patients with a high risk of developing hypersensitivity reactions that require the conduct of PHAG, the study should be conducted in the presence of the resuscitator.

Avoid extravasation of the drug solution due to high pH, as this can lead to severe tissue damage (severe pain in the limb for several hours, peeling of the skin, phlebitis of superficial veins).Before administering the drug, make sure the needle is correctly positioned in the vein. In the case of extravasation of the solution, the drug should be discontinued immediately and the necessary medical measures taken.

Perhaps the effect of the drug on the results of some laboratory tests of blood and urine for 3-4 days.

The effect of sodium fluorescein on the results of the determination of digoxin and cortisol in the blood serum was noted.

Caution should be exercised in the therapeutic monitoring of the concentration of drugs with a narrow therapeutic index (for example, digoxin, quinidine).

Before the introduction of the drug, you should carefully inspect the bottle. A solution of sodium fluorescein can not be used when the color changes or the appearance of undissolved visible particles.

The drug should not be mixed with drugs or diluted with other solutions in the same syringe. You should avoid simultaneous intravenous administration of other drugs or mixing fluorescein sodium solution with other solutions, since it is impossible to exclude the possibility of developing physico-chemical interactions.To prevent reactions of physical incompatibility, the cannula for intravenous administration should be washed before and after the administration of other drugs.

Within 36 hours after the administration of the drug, X-ray examinations are not recommended, as the results can be distorted.

For patients on the hyponatrial diet, it should be noted that the recommended dose of the drug contains 72.45 mg of sodium.

Effect on the ability to drive transp. cf. and fur:

Avoid the management of vehicles, the employment of other potentially hazardous activities that require hanging concentration of attention and speed of psychomotor reactions to the moment of restoration of normal visual activity.

Form release / dosage:Solution for intravenous administration, 100 mg / ml.

Packaging:

5 ml in colorless vials from a glass tube for antibiotics with a capacity of 10 ml, corked with rubber stoppers and aluminum caps.

Each vial with instructions for use in a pack of cardboard box.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003611

Date of registration:12.05.2016

Expiration Date:12.05.2021

The owner of the registration certificate:SSC NIOPIK, FSUE SSC NIOPIK, FSUE Russia

Manufacturer: & nbsp

NIOPIK SRC, FSUE Russia

Information update date: & nbsp10.07.2016

Illustrated instructions

Instructions

Fluorescein sodium (Fluorescein sodium)