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Pharmacological properties

the X-ray contrast agent triombrast is a salt of amidotrizoic acid that contains bound iodine that absorbs X-rays.

Pharmacokinetics

Distribution. After iv administration, the amount of the drug that binds to plasma proteins does not exceed 10%. 5 minutes after the intravenous bolus administration of Triombrast 60% at a dose of 1 ml / kg body weight, the concentration of the drug in the blood plasma is reached, which corresponds to 2-3 g of iodine per liter. Within 3 hours after administration, a relatively rapid decrease in the concentration of the drug is observed during the first 30 minutes, then a gradual decrease with T½ 1-2 hours. Amidotrizoic acid does not penetrate into red blood cells, after intravascular administration it is very rapidly distributed in the intercellular substance, but does not penetrate through the intact BBB. The drug only passes into breast milk in minimal amounts.

Metabolism and elimination. When administered in diagnostic doses, amidotrizoic acid undergoes glomerular filtration in the kidneys. About 15% of the administered drug is excreted unchanged in the urine within 30 minutes after administration, and more than 50% within 3 hours, no metabolites were detected.

The kinetic properties of the distribution and excretion of Triombrast from the body were not dose-dependent within a clinically significant range. This means that with the introduction of a double dose or half of the dose, the level of the drug in the blood and the amount of contrast medium that will be removed from the body, in grams per unit time, respectively, will double or increase. However, due to the increase in osmotic diuresis at a double dose, the concentration of the contrast agent in the urine does not increase to the same extent.

Characteristics in patients. In patients with reduced renal function, amidotrizoate can also be eliminated extrarenal via the liver, although at a significantly reduced rate. Contrast agents that are eliminated by the kidneys can be easily removed from the body by extracorporeal hemodialysis. Regardless of the injection site, a complete elimination occurs even from tissues within a short period of time.

Indications

I / O and retrograde urography.

In addition, angiography, as well as arthrography, intraoperative cholangiography, endoscopic retrograde cholangiopancreatography (ERCP), sialography, fistulography, hysterosalpingography and other studies.

Application

General rules

Diet Tips To facilitate diagnosis, angiography of the abdominal cavity and urography is recommended with a cleaned intestine. Despite this, within 2 days on the eve of the examination, foods that cause flatulence, in particular legumes, salads, fruits, black and fresh bread, as well as any raw vegetables, should be avoided. The last meal should be no later than 18 hours. In addition, it is advisable to take a laxative in the evening. However, newborns and young children can not make a large interval in food intake, and should not be given them a laxative.

Hydration. Before intravascular and intrathecal administration of a contrast medium, as well as after it, it is necessary to ensure adequate hydration. This is especially true for patients with multiple myeloma, diabetes mellitus, polyuria, oliguria, hyperuricemia, as well as newborns, infants and young children and elderly patients. It is necessary to eliminate violations of water-electrolyte metabolism.

Newborns and children under the age of 2 years. Children under the age of 1 year and especially newborns are susceptible to electrolyte imbalance and hemodynamic changes.Attention should be paid to the dose of contrast medium to be administered, the technical performance of the radiological procedure and the condition of the patient.

State of anxiety. Severe arousal, anxiety and pain can increase the risk of side effects and increase the bodys reactions associated with the administration of a contrast medium. A sedative can be given to these patients.

Tolerance test. It is not recommended to carry out a tolerance test using a low dose of a contrast medium, since it has no prognostic value. Moreover, the tolerance test itself sometimes led to severe hypersensitivity reactions, even with a fatal outcome.

Dosage for intravascular administration. Intravascular administration of a contrast medium is desirable when the patient is in a prone position. After its introduction, it is necessary to observe the patient for at least 30 minutes, since most complications arise precisely in this period.

The dose may vary depending on age, body weight, cardiac output and general condition of the patient.

In patients with severe renal or cardiovascular failure and patients with a general serious condition, it is necessary to use the lowest possible dose of contrast medium. They are advised to monitor renal function for at least 3 days after the study.

Between the individual injections, it is necessary to allow the body enough time to drain the interstitial fluid to compensate for the increased osmolality of blood plasma. To achieve this, in adequately hydrated patients, the desired period is 10-15 minutes. If necessary, in some cases, exceeding the total dose of 300-350 ml of contrast medium per study, the introduction of additional water and possibly electrolytes is shown in adults.

Recommended Dosage

In / in urography. Injection. Triombrast 76% and 60% are equally suitable for iv urography.

The rate of intravascular administration is usually 20 ml / min. For patients with heart failure who are prescribed a dose of 100 ml or more, the recommended administration time is at least 20-30 minutes.

Dosage for adults: the dose of Triombrast 76% - 20 ml, Triombrast 60% - 50 ml. An increase in the dose of Triombrast 76% to 50 ml significantly increases the likelihood of a more accurate diagnosis. Its further increase is possible if it is necessary because of special indications.

Dosage for children: due to the reduced physiological concentration ability of the still immature kidney nephron, children need relatively high doses of Triombrast 76%:

  • children under the age of 1 year - 7-10 ml;
  • from 1 year to 2 years - 10-12 ml;
  • 2 years - 12-15 ml;
  • 6-12 years old - 15-20 ml;
  • over 12 years old - as for adults.

Snapshot time taken. You can get the best contrast image of the renal parenchyma if you take a picture immediately after the introduction of contrast medium.

To visualize the renal pelvis and urinary tract, the first picture should be taken after 3-5 minutes, and the second - 10-12 minutes after the administration of a contrast medium, and for young patients should focus on the lower, and for elderly patients - the upper limit of this period of time .

For newborns and infants and young children, the first shot is recommended to be taken 2 minutes after the administration of a contrast agent. If images turn out to be low contrast, later photographs may be needed.

Angiography. Triombrast can also be used for angiographic studies.The use of 76% solution is preferred in cases where a particularly high concentration of iodine is important, for example, for aortography, angiocardiography or coronarography. The dose should be set depending on the diagnostic task, research methodology, nature and volume of the investigated vascular site.

Introduction to body cavities

Retrograde urography. You can apply Triombrast 60%. Despite its high concentration, irritation symptoms are extremely rare. In order to avoid the influence of a lower temperature of the solution, which causes spasms of the ureter, it is recommended to heat the contrast medium to body temperature.

Children. Due to the reduced physiological concentration ability of the still immature kidney nephron, children need relatively high doses of Triombrast 76%.

Contraindications

Proven or suspected sensitivity to iodine-containing contrast agents and drug components.

Existing hyperthyroidism, decompensated heart failure.

During pregnancy, as well as in acute inflammatory processes in the pelvic cavity, hysterosalpingography cannot be performed.

ERCP is contraindicated in acute pancreatitis.

Triombrast can not be used for myelography, ventriculography and cisternography due to the possible provocation of neurotoxic phenomena (pain, convulsions and coma, often fatal) during these studies.

Side effects

With intravascular administration. side effects associated with intravascular administration of iodine-containing contrast agents, usually of mild or moderate severity and transient in nature. however, severe and life-threatening reactions have been reported, as well as fatal reactions. it was found that the prevalence of side effects in patients receiving ionic contrast agents is more than 12% compared with more than 3% in the case of non-ionic contrast agents.

Most often, with intravascular use, reactions such as nausea, vomiting, pain and a general sensation of heat are observed.

Anaphylactic reactions / hypersensitivity: mild angioedema, conjunctivitis, cough, itching, rhinitis, sneezing and urticaria. These reactions, which can occur regardless of the amount of the drug administered and the method of administration, may be the first signs of the initial stage of shock. The introduction of a contrast medium should be stopped immediately, if necessary, conduct specific therapy, preferably iv (see SPECIAL INSTRUCTIONS).

Severe reactions requiring emergency therapy may take the form of circulatory disorders, accompanied by peripheral vasodilation and subsequent hypotension, reflex tachycardia, shortness of breath, a state of agitation, confusion and cyanosis, which can lead to fainting.

Bronchospasm, spasm or swelling of the larynx, arterial hypotension may be observed.

Delayed reactions associated with the introduction of contrast agents occur in isolated cases (see SPECIAL INSTRUCTIONS).

The body as a whole: a feeling of heat and pain, malaise, fever, sweating, vasovagal reactions, fever, swelling of the salivary glands.

On the part of the respiratory system: transient violation of the respiratory rate, shortness of breath, respiratory distress, cough, respiratory arrest, pulmonary edema.

From the cardiovascular system: clinically pronounced transient disturbances in heart rate, blood pressure, impaired heart rate or function, cardiac arrest. Severe reactions requiring emergency therapy may take the form of circulatory disorders, accompanied by peripheral vasodilation and subsequent arterial hypotension, reflex tachycardia, shortness of breath, a state of agitation, confusion and cyanosis, which can lead to fainting. Severe thromboembolic events leading to myocardial infarction have been reported.

From the digestive system: nausea, vomiting, abdominal pain.

From the side of the cerebrovascular system: cerebral angiography and other procedures, during which the contrast medium enters the brain in high concentrations with arterial blood, may be accompanied by transient neurological complications such as dizziness, headache, a state of agitation or confusion, amnesia, impaired speech, vision, hearing, convulsions, trembling, paresis / paralysis, photophobia, temporary loss of vision, coma and drowsiness, severe, in some cases fatal thromboembolic ie phenomena that lead to a stroke.

From the side of the kidneys: impaired renal function, renal failure.

On the part of the skin and subcutaneous tissue: mild angioedema, redness with vasodilation, urticaria, pruritus, erythema, toxic skin reactions such as mucocutaneous syndrome (e.g., Stevens-Johnson or Lyell syndrome).

Local irritation (at the injection site): pain at the injection site occurs mainly with peripheral angiography, leakage of a contrast medium, including triombrast, increases pain at the injection site and edema, which usually goes without consequences, inflammation, tissue necrosis, thrombophlebitis vein thrombosis.

When introduced into other body cavities. After administration of a contrast medium in the body cavity, adverse reactions rarely occur. Most of them develop within a few hours after administration due to slow adsorption from the site of administration and distribution throughout the body, mainly through a controlled diffusion process.

After ERCP, a slight increase in amylase is possible. It is proved that acinous contrast image is associated with an increased risk of developing pancreatitis after ERCP. Cases of necrotizing pancreatitis, vasovagal reactions associated with hysterosalpingography are described.

Anaphylactic reactions / hypersensitivity: systemic hypersensitivity, mainly of a mild degree, usually occurs in the form of skin reactions, but the possibility of developing a severe hypersensitivity reaction cannot be completely ruled out. For a full description of anaphylactic reactions, see the relevant information in the section ADVERSE EFFECTS, With intravascular administration.

special instructions

General information for all indications. The warnings and precautions below apply to any route of administration, but the possibility of the following risk situations is higher with intravascular administration.

Triombrast, injection solution 60%, contains 0.125 mmol (or 2.9 mg) / ml sodium. Caution should be exercised when used in patients who are on a sodium-controlled diet.

Triombrast, injection solution 76%, contains 0.158 mmol (or 3.6 mg) / ml sodium. Caution should be exercised when used in patients who are on a sodium-controlled diet.

Hypersensitivity. From time to time after the use of radiopaque substances, such as Triombrast, allergic-like hypersensitivity reactions are observed (see ADVERSE EFFECTS). They are usually expressed by mild respiratory or skin symptoms, such as mild respiratory distress, redness of the skin (erythema), urticaria, itching, or swelling of the face. Serious adverse reactions, such as angioedema, subchordal edema, bronchospasm and allergic shock, are possible. Typically, such reactions occur within 1 h after administration of a contrast medium. However, in rare cases, delayed reactions are possible (several hours or days after administration).

Patients with hypersensitivity or a previous reaction to radiopaque agents containing iodine are at an increased risk of serious complications.

Before administering any contrast medium, one should determine the patient’s history of allergic reactions (for example, allergies to seafood, hay fever, urticaria), sensitivity to iodine, or radiographic contrast agents and AD, since it was reported that serious reactions to contrast agents developed more often in patients with by these conditions. In this case, premedication with antihistamines and / or glucocorticoids can be used.

Patients with AD are at particular risk of bronchospasm or a hypersensitivity reaction.

Hypersensitivity reactions can worsen in patients taking β-adrenergic blockers, especially in the presence of AD. In addition, it is necessary to take into account that patients who take β-adrenergic receptor blockers may be insensitive to standard therapy of hypersensitivity reactions with β-agonists.

In the event that hypersensitivity reactions are observed (see ADVERSE EFFECTS), the administration of a contrast medium should be stopped immediately and, if necessary, iv therapy should be given. Therefore, for the introduction of a contrast medium, it is recommended to use flexible permanent cannulas (catheters). In order to immediately initiate emergency measures, emergency supplies (appropriate medications and equipment, including an endotracheal intubation tube and respirator) should always be in place.

Thyroid dysfunction. A small amount of free inorganic iodide from an iodine-containing contrast medium can affect the functioning of the thyroid gland. Therefore, it is necessary to carefully approach the study in patients with latent hyperthyroidism or goiter, taking into account the possible risk.

Cardiovascular diseases. There is an increased risk of serious reactions in people with severe heart disease, especially in patients with heart failure and coronary artery disease.

Elderly patients. Vascular pathology and neurological disorders, which are often noted in elderly people, pose an increased risk of serious reactions to iodine-containing contrast agents.

General serious health condition. It is necessary to carefully approach the study in patients with very poor general health conditions, given the possible risk.

Intravascular injection

Renal failure. In isolated cases, temporary renal failure may be observed. Preventive measures aimed at preventing acute renal failure after administration of a contrast medium include:

  • identification of patients at high risk, for example, with a history of kidney disease, renal failure, renal failure after administration of a contrast agent, diabetes mellitus with nephropathy, a decrease in bcc, multiple myeloma, persons over 60 years of age; patients with advanced stage of vascular disease, paraproteinemia, severe hypertension and chronic hypertension, gout; patients receiving high or repeated doses of the drug;
  • ensuring adequate hydration in patients at risk before administering a contrast medium, preferably by maintaining an intravenous infusion before and after the procedure and until the contrast medium is excreted by the kidneys;
  • avoidance of additional burden on the kidneys in the form of nephrotoxic drugs, oral cholecystographic agents, artery clamping, renal arterial angioplasty, radical surgery before removing the contrast medium;
  • postponement of a new study with a contrast medium until the kidney function returns to previous levels.

Dialysis patients can receive contrast agents for radiological procedures, since iodine-containing substances are excreted during the dialysis process.

Therapy with metformin. The use of iv radiopaque substances that are excreted by the kidneys can lead to a transient impaired renal function. It can cause lactic acidosis in patients taking biguanides.

In order to prevent complications, the use of biguanides must be stopped 48 hours before the administration of the contrast medium and at least 48 hours after it. You can resume taking them only after the kidney functions return to normal.

Cardiovascular diseases. In patients with pathology of the heart valves and pulmonary hypertension, the administration of a contrast medium can lead to severe hemodynamic changes. Reactions involving ischemic ECG changes and severe arrhythmia are more common in older people and patients with a history of heart disease.

IV administration of a contrast medium can lead to pulmonary edema in patients with heart failure.

CNS disorders. Particular attention with iv administration of a contrast medium should be given to patients with acute ischemic stroke, acute intracranial bleeding and other conditions, including damage to the BBB, cerebral edema, or acute demyelination. A history of intracranial tumors or metastases and epilepsy can increase the incidence of seizures after administration of an iodine-containing contrast medium.

With the introduction of a contrast agent, neurological symptoms may aggravate due to cerebrovascular diseases, intracranial tumors or metastases, degenerative or inflammatory disorders. Vascular spasm and, as a consequence, cerebral ischemia can be caused by intravenous administration of a contrast medium. Patients with symptomatic cerebrovascular disease, a recent stroke, or frequent transient ischemic attacks are at increased risk for neurological complications.

Severe liver dysfunction. In the case of severe renal failure, the simultaneous presence of severe liver dysfunction can significantly delay the excretion of a contrast medium, which may require hemodialysis.

Myeloma and paraproteinemia. Myeloma or paraproteinemia can create conditions for the development of renal failure after administration of a contrast medium. Appropriate hydration is required.

Pheochromocytoma. Patients with pheochromocytoma may develop a severe hypertensive crisis (sometimes not properly controlled) after iv administration of a contrast medium. Premedication with α-adrenoreceptor blockers is recommended.

Patients with autoimmune disorders. Cases of severe vasculitis or syndromes like Stevens-Johnson syndrome have been reported in patients with a history of autoimmune disorders.

Bulbospinal paralysis (myasthenia gravis). The introduction of iodine-containing contrast agents can increase the severity of symptoms of bulbospinal paralysis.

Alcoholism. Acute or chronic alcoholism can increase BBB permeability. This facilitates the passage of contrast medium into the brain tissue, which may lead to the development of reactions from the central nervous system. Particular attention should be paid to alcoholics and drug addicts because of the reduced threshold for convulsive activity.

Coagulation. Ionic iodine-containing contrast agents exhibit greater anticoagulant activity in vitro than non-ionic contrast agents. However, medical personnel conducting vascular catheterization should take into account that in addition to the contrast agent, the development of thromboembolic events can be caused by numerous factors, including the duration of the procedure, the number of injections, the material from which the catheter and syringe are made, the state of the underlying disease, and the concomitant drug.Therefore, during the vascular catheterization procedure, it is necessary to carefully monitor the angiography technique, often flush the catheter with a physiological solution (if possible, with the addition of heparin) and reduce the duration of the procedure in order to minimize the risk of thrombosis and embolism associated with the procedure.

It has been reported that using plastic syringes instead of glass syringes reduces, but does not eliminate, the likelihood of in vitro blood clotting.

Particular attention is recommended to patients with homocystinuria because of the increased risk of thrombosis and embolism.

Introduction to body cavities. Before hysterosalpingography, pregnancy must be excluded.

Inflammation of the bile ducts and fallopian tubes may increase the risk of reactions after cholangiography, ERCP and hysterosalpingography.

Instructions for use. Triombrast is a transparent, colorless or pale yellow solution, ready for use. Contrast agents should not be used in case of significantly changed color, mechanical inclusions or damage to the container. The contrast medium solution should be drawn into a syringe or infusion bottle attached to the infusion equipment, just before the start of the study.

A contrast medium that has not been used in one procedure should be disposed of.

Use during pregnancy or lactation. The results of studies on reproductive toxicity using meglumine or sodium amidotrizoate do not indicate the existence of teratogenic or any other embryotoxic effect after the unintentional administration of triombrast during pregnancy.

The safety of the use of contrast agents in pregnant women has not been adequately demonstrated. Since it is desirable for them to avoid any radiation exposure, it is necessary to carefully approach the appointment of an X-ray examination - with or without contrast - because of the possible risk.

Contrast substances, such as Triombrast, which are excreted from the body by the kidneys, penetrate into breast milk in very small quantities.

There is a limited amount of information that suggests that the risk to the infant due to the administration of diatrizoic acid salts to its mother is small. Breastfeeding is probably safe.

The ability to influence the reaction rate when driving vehicles or other mechanisms. After administration of a contrast medium, as with the use of all iodine-containing contrast agents, in isolated cases there is the possibility of delayed reactions that can impair the ability to control machines and mechanisms.

Interactions

In patients who took interleukin, the prevalence of delayed reactions (e.g. fever, rash, flu-like symptoms, joint pain, and itching) is higher.

Interaction with diagnostic tests. After intravascular administration of iodine-containing contrast agents, the ability of thyroid tissue to absorb radioisotopes for the diagnosis of thyroid diseases decreases for a period of up to 2 weeks, and in some cases even for a longer period.

Overdose

In case of accidental overdose with intravascular administration, the loss of water and electrolytes must be compensated by infusion. renal function requires monitoring for at least 3 subsequent days.

If necessary, hemodialysis can be used to remove the bulk of the contrast medium from the patient’s circulatory system.

Storage conditions

In the original packaging at a temperature not exceeding 25 ° c. do not freeze.

When storing the drug, crystals may precipitate.In such cases, the ampoule must be heated in a boiling water bath. If the crystals disappear and the solution becomes transparent, and when cooled to 33–36 ° C, the crystals do not drop out again, the solution is suitable for use.

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