Iobrix (Solution) Instructions for Use

ATC Code

V08AB02 (Iohexol)

Active Substance

Iohexol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Radiocontrast non-ionic diagnostic agent for intravascular, intracavitary administration and oral intake

Pharmacotherapeutic Group

Radiocontrast agent

Pharmacological Action

Radiocontrast diagnostic non-ionic monomeric agent. It has low osmolarity. Iohexol is well soluble in water and contains approximately 46.4% iodine.

The time to reach maximum radiocontrast in conventional myelography is up to 30 minutes (it is no longer visualized after 1 hour). During CT, visualization of the contrast in the thoracic region is possible for 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 protrusions, pancreatic and bile ducts, and the urinary bladder is achieved immediately after administration.

Pharmacokinetics

After IV 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 IV injection and reaches 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).

T_1/2 in the initial phase is about 20 minutes, intra- 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% within 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 mcg/ml. V_d is 157 ml/kg. T_1/2 is 3.4 hours.

When taken orally, it enhances 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 (enhancement of 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 100-400 mg iodine/kg for urography. Use 300-600 mg iodine/kg for cerebral angiography. Use 200-400 mg iodine/kg for computed tomography enhancement.

For pediatric intravascular use, administer 1-3 ml/kg (300 mg iodine/ml) for urography. Do not exceed 3 ml/kg for intravenous digital subtraction angiography.

For subarachnoid administration in lumbar myelography, use 10-15 ml (180 mg iodine/ml) or 8-12 ml (240 mg iodine/ml). For thoracic and cervical myelography, use 10-12 ml (240 mg iodine/ml) or 7-10 ml (300 mg iodine/ml).

For intracavitary use, inject 5-20 ml (240-350 mg iodine/ml) for arthrography. Use 10-40 ml (240-350 mg iodine/ml) for hysterosalpingography. Administer 0.2-2.0 ml (240-350 mg iodine/ml) for sialography.

For oral administration in gastrointestinal tract studies, dilute the solution to 3-6 mg iodine/ml concentration. Administer 500-2000 ml of the diluted solution for adult patients.

Adjust the dose for geriatric patients and patients with severe renal or hepatic impairment. Ensure adequate hydration before and after administration.

Adverse Reactions

With intravascular use nausea, vomiting, pain at the injection site, temporary feeling 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 re-examination is contraindicated), infectious diseases.

Use in Pregnancy and Lactation

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

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 radiocontrast 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), with 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 in patients with severe thyrotoxicosis, myelomatosis should be considered.

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

Careful monitoring of the patient is necessary if a decrease in the 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 drugs.

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.