Nioskan (Solution) Instructions for Use

ATC Code

V08AB02 (Iohexol)

Active Substance

Iohexol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Radiopaque diagnostic agent

Pharmacotherapeutic Group

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

Pharmacological Action

X-ray contrast diagnostic nonionic monomeric agent. It has low osmolarity. Iohexol is well soluble in water and contains approximately 46.4% iodine.

The time to reach maximum radiopacity during conventional myelography is up to 30 minutes (it is no longer visualized after 1 hour). During CT, contrast visualization in the thoracic region is possible for up to 1 hour, in the cervical region for about 2 hours, and in the basal cisterns for 3-4 hours. Contrasting of joint cavities, the uterine cavity, fallopian tubes, peritoneal diverticula, pancreatic and bile ducts, and the urinary bladder is achieved immediately after administration.

Pharmacokinetics

After intravenous administration, C_max is noted immediately after administration. It is distributed in the extracellular fluid. It rapidly accumulates in the kidneys: renal passage contrast begins 1 minute after intravenous injection and reaches its optimum in 5-15 minutes. It binds to plasma proteins and cerebrospinal fluid proteins to a small extent. It penetrates the placental barrier by simple diffusion. It does not penetrate the intact blood-brain barrier.

It is excreted by glomerular filtration unchanged (about 90% within 24 hours).

The T_1/2 in the initial phase is about 20 minutes; intravascular and extravascular concentrations equalize within 10 minutes, then the concentration decreases exponentially with a T_1/2 of about 2 hours. Renal clearance is 120 ml/min, total clearance is 131 ml/min, V_d is 165 ml/kg.

After intrathecal administration, it is absorbed from the cerebrospinal fluid into the bloodstream and is completely excreted by the kidneys (about 88% during the first day) unchanged. Renal clearance is 99 ml/min, total clearance is 109 ml/min. C_max in blood plasma is reached after 2-6 hours and is 119 µg/ml. V_d is 157 ml/kg. T_1/2 is 3.4 hours.

When taken orally, it enhances the visualization of the gastrointestinal tract and is practically not absorbed (0.1-0.5% is excreted by the kidneys); absorption increases significantly in the presence of intestinal perforation or intestinal obstruction.

Indications

Intravascular use: angiography of the lungs, head, neck, brain, abdomen, kidneys; angiocardiography, aortography, phlebography, urography; computed tomography (to improve resolution).

Subarachnoid use: lumbar myelography, thoracic myelography, cervical myelography, computed tomography of the basal cisterns.

Intracavitary use: arthrography, retrograde endoscopic pancreatography, retrograde endoscopic cholangiopancreatography, herniography, hysterosalpingography, sialography.

Oral use: gastrointestinal tract studies.

ICD codes

Dosage Regimen

Determine the dose individually based on the diagnostic procedure, patient age, and body weight.

For intravascular administration in adults, use the following typical doses. For cerebral angiography, administer 5-10 ml per injection. For aortography, use 20-60 ml. For peripheral arteriography, administer 10-40 ml. For excretory urography, use 20-50 ml intravenously. For CT enhancement of the head, administer 50-150 ml; for the body, use 75-150 ml intravenously.

For subarachnoid administration in adults for myelography, use the following typical doses. For lumbar myelography, administer 10-15 ml. For thoracic myelography, use 10-15 ml. For cervical myelography, administer 8-10 ml via lateral C1-C2 puncture or 15 ml via lumbar route.

For intracavitary administration in adults, use the following typical doses. For arthrography, administer 5-20 ml. For hysterosalpingography, use 10-20 ml. For ERCP, inject 10-30 ml into the pancreatic duct or 20-50 ml into the biliary duct.

For oral administration for gastrointestinal studies, dilute the solution to an iodine concentration of approximately 21 mg/ml. Administer 500-1000 ml orally for gastric and small bowel opacification. For colonic opacification, administer up to 2000 ml as an enema.

Adjust the dose for pediatric patients strictly based on body weight. For pediatric excretory urography in children under 6.5 kg, administer 4 ml/kg; for children over 6.5 kg, use 3 ml/kg with a maximum single dose of 40 ml. For pediatric CT scanning, administer 1-3 ml/kg intravenously.

In patients with renal impairment, use the lowest effective dose. Ensure adequate hydration before and after administration to minimize nephrotoxicity. Monitor patients with pre-existing renal conditions closely.

For geriatric patients, use the minimum dose necessary to achieve adequate diagnostic visualization due to age-related decline in renal function.

Adverse Reactions

With intravascular use: nausea, vomiting, pain at the injection site, temporary sensation of heat, redness of the skin.

With subarachnoid use (for myelography): headache, transient dizziness, pain in the back, neck, limbs, paresthesia, nausea, vomiting; in isolated cases (in predisposed patients) – convulsions; a case of aseptic meningitis has been reported.

Contraindications

Pregnancy, hypersensitivity to iodine-containing contrast agents.

Subarachnoid administration: epilepsy, technical failure during myelography (immediate repeat examination is contraindicated), infectious diseases.

Use in Pregnancy and Lactation

Contraindicated during pregnancy. If it is necessary to use iohexol during lactation, the possibility of minimal penetration into breast milk should be considered.

Use in Hepatic Impairment

Use with caution in severe liver dysfunction.

Use in Renal Impairment

Use with caution in severe renal impairment.

Geriatric Use

Use with caution in the elderly.

Special Precautions

Use with caution in patients with a history of allergic reactions to radiopaque contrast agents, with bronchial asthma, hay fever, food allergy, thyrotoxicosis, myelomatosis, diabetes mellitus, severe liver and/or kidney dysfunction, dehydration, decompensated cardiovascular diseases (including chronic heart failure), chronic alcoholism, multiple sclerosis, pheochromocytoma, sickle cell anemia, obliterating thromboangiitis (Buerger’s disease), acute thrombophlebitis, severe atherosclerosis, in the elderly, during lactation; when performing lumbar puncture in the presence of local or systemic infections.

In patients with an increased risk of developing allergic reactions, preliminary therapy with corticosteroids and/or antihistamines is advisable.

The possibility of dehydration development in patients with severe thyrotoxicosis and myelomatosis should be considered.

In patients with diabetes mellitus and serum creatinine concentration above 500 µmol/L, the use of iohexol is possible only in cases of extreme necessity.

Careful monitoring of the patient is necessary if a lowered seizure threshold is suspected.

After the use of iohexol, the iodine-binding capacity of the thyroid tissue is reduced for a period from several days to 2 weeks.

Drug Interactions

When using iohexol in patients receiving phenothiazine derivatives and other antipsychotic agents (neuroleptics), MAO inhibitors, tricyclic antidepressants, CNS stimulants, analeptics, the seizure threshold is lowered and the risk of epileptic seizures increases.

Antihypertensive agents (including beta-blockers) increase the likelihood of arterial hypotension.
Iohexol enhances the nephrotoxic properties of other medicinal products.

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.