Visipaque (Solution) Instructions for Use

ATC Code

V08AB09 (Iodixanol)

Active Substance

Iodixanol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Radiocontrast non-ionic diagnostic agent for intravascular administration

Pharmacotherapeutic Group

Contrast agents; X-ray contrast agents containing iodine; water-soluble nephrotropic low-osmolar X-ray contrast agents

Pharmacological Action

X-ray contrast non-ionic dimeric agent. It is a hexaiodinated compound, water-soluble. Iodixanol contains approximately 49.1% iodine.

The organically bound iodine, introduced into the bloodstream and delivered to organs and tissues, absorbs X-rays.

Aqueous solutions of iodixanol in all clinically used concentrations have lower osmolarity than whole blood and monomeric non-ionic X-ray contrast agents at comparable concentrations.

Indications

Adults: selective cerebral arteriography, selective cerebral intra-arterial digital subtraction arteriography (DSA), aortography, peripheral arteriography, peripheral intra-arterial DSA, cardioangiography.

For intravenous administration: intravenous excretory urography, limb venography. Contrast enhancement in computed tomography. Gastrointestinal tract examinations. Examinations of the spinal cord and surrounding tissues (lumbar, thoracic and cervical myelography), arthrography, hysterosalpingography.

Children: cardioangiography, urography, contrast enhancement in computed tomography and gastrointestinal tract examination.

ICD codes

Dosage Regimen

Administer Visipaque solution intra-arterially, intravenously, intrathecally, intracavitarily, or rectally.

Determine the exact dose based on the specific type of diagnostic examination, patient’s age, body weight, and general clinical condition.

For adults, use for selective cerebral arteriography, aortography, peripheral arteriography, cardioangiography, and intra-arterial digital subtraction arteriography.

For intravenous administration in adults, use for excretory urography, limb venography, contrast-enhanced computed tomography, and gastrointestinal tract examinations.

For intrathecal use in adults, administer for examinations of the spinal cord and surrounding tissues, including lumbar, thoracic, and cervical myelography.

For intracavitary administration in adults, use for arthrography and hysterosalpingography.

In children, administer for cardioangiography, urography, contrast-enhanced computed tomography, and gastrointestinal tract examination.

Adjust the dosage for pediatric patients according to body weight and the specific procedural requirements.

Ensure strict adherence to the recommended concentration and volume for each specific route of administration and diagnostic procedure.

Adverse Reactions

After intra-arterial or intravenous injection

Infrequent allergic reactions (hypersensitivity), headache, flushing, nausea, vomiting, rash or drug rash, itching, urticaria, acute kidney injury or toxic nephropathy (contrast-induced nephropathy, CIN), chest pain, sensation of change in body temperature.

Rare dizziness, sensory disturbance, dysgeusia, paresthesia, parosmia, arrhythmia, tachycardia, bradycardia, myocardial infarction, arterial hypotension, cough, sneezing, chills, febrile state, pain and discomfort, injection site reactions, extravasation.

Very rare agitation, anxiety, acute cerebrovascular accident, amnesia, syncope, transient tremor, hypesthesia, transient cortical blindness, diplopia, blurred vision, eyelid edema, cardiac arrest; palpitations; increased blood pressure, ischemia, dyspnea, throat irritation, laryngeal edema, abdominal pain or discomfort, diarrhea, hoarseness, barking cough, difficulty breathing, facial edema, edema of the eyelids, tongue, larynx (angioedema), skin redness, increased sweating (hyperhidrosis), back pain, muscle spasms, asthenic conditions (e.g., malaise, fatigue), facial edema, localized edema.

Frequency unknown thrombocytopenia, hyperthyroidism, hypothyroidism, confusion, coma, impaired consciousness, seizures, temporary brain damage which may manifest as headache, dizziness, forgetfulness, absent-mindedness, irritability, obsessive movements, decreased vision and hearing (transient encephalopathy), palpitations, heart failure, ventricular hypokinesia, coronary artery spasm, cardiac and respiratory arrest, slow pulse, conduction disorder, coronary artery thrombosis, angina pectoris, shock, thrombophlebitis, non-cardiogenic pulmonary edema (related to pulmonary vessels), respiratory arrest, respiratory failure, bronchospasm, feeling of throat tightness, pharyngeal edema, acute pancreatitis, exacerbation of pancreatitis, salivary gland enlargement, skin rash, bullous or exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms, arthralgia, increased blood creatinine concentration, swelling, iodism.

After intrathecal administration

Infrequent headache (may be severe and prolonged), vomiting.

Frequency unknown allergic reaction, including anaphylactic/anaphylactoid reactions, coma, impaired consciousness, seizures, transient encephalopathy, nausea, muscle spasms, chills, injection site pain.

After examination of the uterus and fallopian tubes

Very common abdominal pain, vaginal bleeding.

Common headache, nausea, fever.

Infrequent vomiting.

Frequency unknown allergic reaction (hypersensitivity), chills, injection site pain.

After injection into joints

Common injection site pain.

Frequency unknown allergic reaction (hypersensitivity), including anaphylactic/ anaphylactoid reactions, chills.

After gastrointestinal tract examination

Common diarrhea, abdominal pain, nausea.

Infrequent vomiting.

Frequency unknown allergic reaction (hypersensitivity), including anaphylactic/anaphylactoid reactions, mild chills.

Contraindications

Manifest thyrotoxicosis, chronic heart failure in the decompensation phase, allergic reactions to iodine-containing X-ray contrast agents, to Iodixanol.

Use in Pregnancy and Lactation

During pregnancy, Iodixanol should be used only in cases of extreme necessity.

Breastfeeding should be discontinued before the administration of the X-ray contrast agent and resumed no earlier than 24 hours after administration.

Use in Hepatic Impairment

Caution should be exercised when using non-ionic X-ray contrast agents in patients with severe combined hepatic and renal impairment, as their clearance of contrast agents is significantly reduced.

High concentrations of this agent in the patient’s plasma may affect the results of laboratory tests for bilirubin concentration. Therefore, such tests should not be performed on the day of the examination.

Use in Renal Impairment

The risk of developing renal function impairment with the use of iodixanol is increased in patients with a history of kidney disease, diabetic nephropathy, and myeloma.

In patients with impaired renal function, the clearance of iodixanol is reduced; with combined hepatic and renal impairment, a significant decrease in clearance occurs.

Pediatric Use

Used in children from birth according to indications.

Geriatric Use

Use with caution in elderly persons.

Special Precautions

Strict adherence to the correspondence of the used dosage form with the indications for use is necessary.

Use with caution in patients with bronchial asthma, hyperthyroidism, cardiovascular diseases, and in elderly persons. If there is a history of bronchial asthma attacks, allergic reactions to the administration of iodine-containing drugs, premedication with corticosteroids or antihistamines can be used.

It is recommended to use Iodixanol only when conditions for emergency measures are available in case of severe adverse reactions, including anaphylactic shock.

The risk of developing renal function impairment with the use of iodixanol is increased in patients with a history of kidney disease, diabetic nephropathy, and myeloma. In patients with impaired renal function, the clearance of iodixanol is reduced; with combined hepatic and renal impairment, a significant decrease in clearance occurs.

Dehydration should be avoided before the administration of the contrast agent.

On the day of iodixanol administration, the plasma levels of bilirubin, proteins, iron, copper, calcium, and phosphates should not be determined. For 2 weeks after the use of iodixanol, the iodine-binding capacity of the thyroid tissue is reduced.

Effect on ability to drive vehicles and operate machinery

One should not engage in potentially hazardous activities for 24 hours after the use of iodixanol.

Drug Interactions

When used concomitantly with antipsychotics, analgesics and antidepressants, Iodixanol may lower the seizure threshold, increasing the risk of adverse reactions.

The use of iodixanol in patients with diabetic nephropathy taking biguanides (metformin) may lead to transient impairment of renal function and the development of lactic acidosis. As a precaution, biguanides should be discontinued 48 hours before the examination and resumed after complete stabilization of renal function.

Patients who have received interleukin-2 less than 2 weeks before the examination are prone to an increased frequency of delayed adverse reactions (flu-like conditions or skin reactions).

In patients taking beta-blockers, the manifestations of anaphylaxis with the use of iodixanol may be atypical and mistakenly taken for vagal reactions. Patients with bronchial asthma receiving concomitant therapy with beta-blockers are at greater risk.

All iodine-containing contrast agents can affect the ability of the thyroid gland to bind iodine, which may be reduced for several weeks, which will affect the results of the iodine uptake test (using radioactive iodine).

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.