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Hexabrix 320 (Solution) Instructions for Use

Marketing Authorization Holder

Guerbet (France)

ATC Code

V08AB03 (Ioxaglic acid)

Active Substance

Ioxaglic acid (Rec.INN registered by WHO)

Dosage Form

Bottle Rx Icon Hexabrix 320 Injection solution 320 mg iodine/ml: 10 ml, 20 ml, 50 ml, 100 ml or 200 ml fl. 1 pc.

Dosage Form, Packaging, and Composition

Solution for injection transparent, colorless or light yellow.

1 ml
Ioxaglate meglumine 393 mg
Ioxaglate sodium 196.5 mg,
   Which corresponds to the content of radioactive iodine 320 mg

Excipients : calcium disodium edetate 0.1 mg, water for injections up to 1 ml.

10 ml – glass bottles (1) – cardboard packs.
20 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.
10 ml – glass bottles (25) – cardboard packs (for hospitals).
20 ml – glass bottles (25) – cardboard packs (for hospitals).
50 ml – glass bottles (25) – cardboard packs (for hospitals).
100 ml – glass bottles (10) – cardboard packs (for hospitals).
200 ml – glass bottles (10) – cardboard packs (for hospitals).

Clinical-Pharmacological Group

Radiocontrast ionic diagnostic agent for intravascular and intracavitary administration

Pharmacotherapeutic Group

Radiocontrast agent

Pharmacological Action

Hexabrix 320 is a radiocontrast agent for blood vessels, urinary tract, joint cavities, uterine cavity and appendages.

The active substances of the drug are a product of the interaction of the active component ioxaglic acid and the auxiliary components meglumine and sodium hydroxide. Ioxaglate is the only ionic low-osmolar radiocontrast agent.

Due to its effect on hemostasis, Hexabrix 320 reduces the risk of thrombus formation in catheters and guides used during angioplasty. The results of several clinical studies conducted in the setting of percutaneous transluminal coronary angioplasty suggest that Hexabrix 320 plays a role in reducing the immediate risk of thrombosis associated with this intervention.

Pharmacokinetics

After intravascular injection, the drug is distributed in the circulatory system and interstitial space without a pronounced increase in blood volume or disturbance of hemodynamic equilibrium.

It is rapidly excreted by the kidneys unchanged (not metabolized) by glomerular filtration. Due to the low osmolality of the solution, osmotic diuresis is very low.

In patients with renal failure, the drug may be excreted through alternative routes – biliary tract, salivary glands, sweat and colon.

The components constituting the drug may be excreted by dialysis.

Indications

  • Intravenous urography;
  • Angiography of any location, including cerebral and coronary angiography;
  • Arthrography;
  • Hysterosalpingography;
  • Sialography.

ICD codes

ICD-10 code Indication
Z03 Medical observation and evaluation for suspected disease or pathological condition
ICD-11 code Indication
QA02 Medical observation or examination for suspected diseases or conditions that were ruled out

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.
Indications Comments
Average dose Total dose Average dose Total dose
Intravenous urography 1 ml/kg From 50 to 150 ml Over 1 year: 2 ml/kg;
Up to 1 year: 2-4 ml/kg		 Up to 12 kg: 2 ml/kg
Over 12 kg: 1.5 ml/kg, min. 24 ml
Over 10 years: lower dosage level for adults		 The dose of the drug should be selected depending on the patient’s body weight and renal function. The patient should be fasting, but fluid intake should not be restricted.
Angiography < 4-5 ml/kg, divided into repeated injections Should not exceed 100 ml in each injection > 1 year: 4 ml/kg
< 1 year: 4-8 ml/kg		 The injection rate depends on the type of examination being performed.
Arthrography 10 ± 2 ml From 2 to 4 ml/kg From 1 to 2 ml
– knee From 8 to 10 ml, double contrast: from 3 to 5 ml
– shoulder Up to 10 ml, double contrast: up to 5 ml
– hip Up to 5 ml; up to 20 ml after hip neck endoprosthesis replacement
– ankle Up to 5 ml
– elbow Up to 5 ml; double contrast: up to 1 ml
– hand and finger From 0.5 to 2 ml
Hysterosalpingography From 10 to 20 ml depending on the volume of the uterine cavity Slow administration through the cervix using a syringe or cannula
Sialography 3 ml From 1 to 6 ml Intraductal administration into the excretory ducts of the glands.

Adverse Reactions

Like all iodine-containing contrast agents, Hexabrix 320 can cause mild, serious or even fatal reactions. These reactions are always unpredictable, but are more common in patients with a history of allergy or anxiety, or in patients who have had a hypersensitivity reaction during a previous examination using iodine-containing contrast. An iodine sensitivity test cannot predict the development of these reactions.

Harmless reactions may develop: feeling of heat, flushing, less often – nausea and vomiting. These reactions are transient and resolve without consequences.

More serious reactions, which often occur quickly but may be delayed, include skin symptoms, respiratory disorders, neurosensory and gastrointestinal disorders, which may be observed either individually or in combination. In some cases, fever and chills may be associated with these symptoms or occur independently.

Adverse effects associated with specific use

  • Pelvic pain and fainting during hysterosalpingography;
  • Moderate and transient pain with intra-articular administration and/or intra-articular exudation during arthrography.

Contraindications

  • Subarachnoid or epidural administration, as it may cause convulsions and lead to death;
  • Severe thyrotoxicosis;
  • Hypersensitivity to ioxaglic acid or to any of the components of the drug;
  • Performance of hysterosalpingography during pregnancy or in the presence of an acute inflammatory process in the abdominal area.

With caution in patients with severe hepatic insufficiency, chronic heart failure, severe respiratory failure, with a history of allergic reactions (hay fever, food allergy), bronchial asthma, diabetes mellitus, myeloma, hyperuricemia, pheochromocytoma, pulmonary emphysema.

Use in Pregnancy and Lactation

No teratogenic effect was found in animal experiments.

Isolated iodine overload of the body after administration of a contrast agent may theoretically lead to impaired thyroid function in the fetus if the examination is performed after 14 weeks after the cessation of menstruation. However, given the reversibility of this effect and the expected benefit for the mother associated with a thorough examination for any pathology, conducting the examination during pregnancy seems justified. The drug should not be used in pregnant women, except in cases where the intended benefit to the mother outweighs the potential risk to the fetus, and such a study is prescribed by a doctor due to its necessity.

Since there are no data on the passage of the drug into breast milk, breastfeeding should be temporarily discontinued for at least 24 hours.

Use in Hepatic Impairment

With caution in patients with severe hepatic insufficiency.

Pediatric Use

Prescribed in accordance with the dosage regimen

Special Precautions

Due to the risk associated with the use of the drug, the physician should ensure constant medical supervision and maintain venous access throughout the examination procedure. Equipment for emergency resuscitation should always be ready.

In patients with renal failure, diabetes mellitus, myeloma, hyperuricemia, children under 7 years of age and in patients with atherosclerosis, it is important to avoid dehydration before the examination and maintain sufficient diuresis.

Effect on ability to drive vehicles and mechanisms

The drug may affect the ability to drive vehicles and engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions, taking into account the side effect profile, therefore use with caution.

Overdose

Overdose may manifest as cardiorespiratory failure and renal failure. The functions of the main vital organs must be restored by emergency symptomatic treatment. Violation of water and electrolyte balance can be compensated by rehydration. Renal function should be monitored for at least three days. Hemodialysis is performed if necessary.

Drug Interactions

No significant interactions of Hexabrix 320 with other drugs have been identified, however, this medication should not be mixed with others during administration.

Combinations of drugs requiring precautions

Beta-blockers

In case of shock or decreased blood pressure during administration of ioxaglic acid, beta-blockers suppress compensatory reactions from the cardiovascular system.

Before performing an X-ray examination, the use of beta-blockers should, if possible, be discontinued. If the continuity of therapy is extremely important for the patient, appropriate resuscitation equipment should be ready.

Diuretics

If diuretics have caused dehydration, this increases the risk of developing acute renal failure, especially when using large doses of ioxaglic acid. The patient should be rehydrated before administration of ioxaglic acid.

Metformin

In diabetic patients, decreased renal function caused by X-ray examination may be a trigger for the development of lactic acidosis. Metformin intake should be temporarily discontinued 48 hours before and resumed only 2 days after the X-ray examination.

Combinations of drugs to be taken into account

Interleukin II

The risk of developing a reaction to the administration of contrast agents increases if the patient has previously received intravenous therapy with interleukin II: skin rash or, less commonly, decreased blood pressure, oliguria and even renal failure.

Storage Conditions

Store in a place protected from light and out of reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

By prescription.

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.

Medical Disclaimer

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