Clinical and pharmacological group: & nbsp

Radiopaque means

Included in the formulation
  • Yopromide
    solution for injections 
    JODAS EKSPOIM, LLC     Russia
  • Yopromide TP
    solution for injections 
    Tiarex, LLC     Russia
  • Yopromide-Biarvist
    solution for injections 
    ALVILS, LTD.     Russia
  • Yopromide-TL
    solution for injections 
  • Ultravist®
    solution for injections 
    Bayer AG     Germany
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    V.08.A.B   Water-soluble low-osmolarity radiopaque substances for the study of the kidneys

    Pharmacodynamics:Radiopaquenon-ionic monomeric agent. Yopromide contains approximately 48.1% iodine. Has low osmolarity. Due to the presence of stably bound iodine absorbs X-rays and provides a high degree of opacity of the objects of study. Organic iodine compounds absorb X-rays and, selectively accumulating in separate structures of the body, provide a high degree of their opacity, highlighting them against the background of other structures that do not contain iodine. The degree of contrast is directly proportional to the concentration of the iodine-containing contrast agent in the tissue. After intravascularon the introduction of consistently contrasts blood vessels for blood flow, allowing you to visualize their internal structure before the onset of significant hemodilution.
    Pharmacokinetics:

    After intravascular injection iopromide very quickly distributed in the intercellular space. The half-life in the distribution phase is 3 minutes, in the elimination phase - 2 hours regardless of the dose.

    When yopromide is used in doses recommended for diagnostic purposes, it is excreted from the body solely by glomerular filtration. The rate of renal excretion is approximately 18% of the dose for 30 minutes, about 60% for 3 hours and about 92% for 24 hours. Metabolites of iopromide in humans are not found.

    Indications:

    To enhance the contrast of images in computed tomography, digital subtraction angiography, intravenous urography, phlebography of extremities, myelography.

    To enhance the image contrast when visualizing body cavities in arthrography, hysterosalpingography, fistulography.

    With subarachnoidal administration (for iopromide-240) - myelography, CT-myelography.

    XXI.Z00-Z13.Z03   Medical surveillance and evaluation in case of suspected disease or pathological condition

    Contraindications:

    Expressed thyrotoxicosis.

    Hysterosalpingography in the presence of acute inflammatory diseases of the pelvic organs, during pregnancy.

    Conduction of endoscopic retrograde cholangiopancreatography in acute pancreatitis.

    Hypersensitivity to iopromide.

    Carefully:With caution should be used in case of circulatory failure with the phenomena of decompensation, severe impairment of liver and kidney function, pulmonary emphysema, severe cerebral arteriosclerosis, decompensateddiabetes mellitus, increased blood coagulability, nodular goiter, plasmacytoma, general severe condition, in elderly patients.
    Pregnancy and lactation:

    Recommendation category B. In pregnancy, hysterosalpingography is contraindicated.

    In other cases, the possible risk associated with radiopaque testing should be carefully evaluated.

    There is no information on the penetration into breast milk. It is recommended to temporarily stop breastfeeding after the administration of iopromide.

    Dosing and Administration:

    Intravenous, intra-arterial, subarachnoid, intracavitary.

    Angiography. The dose depends on the patient's age and body weight, cardiac output, diagnostic task, type of technical equipment, and the type and volume of the vascular region being examined.

    Digital subtraction angiography. To obtain high-contrast images of large vessels, pulmonary arteries, as well as arteries of the neck, head, kidneys and extremities, use iopromide-300 or yopromide-370 in a volume of 30-60 ml.

    CT scan. For the computer tomography of the head, the following doses are recommended for adults: iopromide-240 - 1.5 ml / kg (max 2.5 ml / kg), iopromide-300 - 1 ml / kg (max. 2 ml / kg), iopromide-370 - 1 ml / kg (max. 1.5 ml / kg).

    Side effects:

    From the digestive system: nausea, vomiting.

    From the cardiovascular system: atrioventricular block, bradycardia, coronary thrombosis, thromboembolic complications, myocardial infarction and acute disorders of cerebral circulation, loss of consciousness, hypertension, arterial hypotension.

    From the urinary system: retention of urine, increased frequency of urination, nephropathy.

    From the side of the central nervous system: headache, dizziness, confusion, paresthesia, a violation of taste sensations, drowsiness.

    Allergic reactions: hypersensitivity (including crossover to iodine or other iodine-containing drugs), pseudoallergic reactions, anaphylactic shock, pruritus, urticaria, sneezing, lacrimation, difficulty breathing, redness of the skin.

    Other: chills, increased sweating, carcinogenicity or mutagenicity, increased prothrombin and thromboplastin time.

    Local reactions: feeling of heat and pain in the place of intravascular injection, bleeding at the injection site, unusual sensations of heat and redness of the skin, necrosis of tissues during extravasation.

    Overdose:

    Intravascular administration

    Symptoms may include a violation of the balance of fluid and electrolytes, kidney failure, complications of the cardiovascular system and lungs. It is necessary to monitor the level of fluid, electrolytes, kidney function.

    Treatment should be aimed at maintaining vital body functions. The drug can be removed from the body by dialysis. In the case of an erroneous dose exceeding with intravascular injection of the drug into the human body, it is necessary to compensate for the loss of water and electrolytes by infusion. It should be monitored for kidney function for at least 3 days.

    If necessary, hemodialysis can be used to remove the main part of the contrast medium from the human body.

    Introduction to the membranes of the brain

    Symptoms: possibly the development of serious neurological complications. It is recommended to carefully monitor the patient's condition.

    Treatment: to prevent a large amount of the drug in the ventricles of the brain should be made as far as possible the complete aspiration of contrast medium. In the case of an erroneous dose increase when the drug is injected under the membranes of the brain, it is necessary to carefully monitor the manifestations of severe CNS disorders for at least the first 12 hours. Such signs may be incremental increase reflexes or tonic-clonic spasms of the muscles,in severe cases involving CNS - generalized convulsions, hyperthermia, stupor and respiratory depression.

    Interaction:

    Preparations for oral cholecystography - there may be an increased risk of kidney failure, especially if liver function is impaired.

    Biguanides (metformin): in patients taking biguanides, with intravascular injection of yopromide, cumulation biguanides and the development of lactic acidosis. To prevent this complication, you should stop taking biguanides 48 hours before the radiocontrast study and do not resume it for at least 48 hours after the contrast agent is injected. Resume their reception should only after the restoration of kidney function.

    Simultaneous use of neuroleptics and antidepressants can reduce the convulsive threshold, increasing the risk of reactions associated with the use of contrast media.

    Patients taking beta-blockers may be resistant to drugs that have a beta-agonist effect, used to treat hypersensitivity reactions.

    Interleukin-2: the risk of developing delayed reactions in response to the administration of the drug is increased by preliminary treatment (within a few weeks) of patients interleukin-2 .

    Effect on diagnostic tests

    Radioisotopes: within a few weeks after the administration of the drug, the thyrotropic isotope absorption in the thyroid gland decreases, which reduces their effectiveness for diagnosis and treatment of thyroid diseases.

    Pharmaceutically incompatible with other medicines.

    Special instructions:

    It must be taken into account that the drug distorts the results of thyroid radioisotope studies within 2 weeks.

    In patients with diabetic nephropathy who take biguanides, lactacidosis may develop (in order to prevent this complication, biguanide intake should be discontinued 48 hours before the radiocontrast study and resumed after a control study shows no impairment of renal function). Hypersensitivity reactions may be more pronounced in patients receiving beta-blockers.

    Delayed reactions (including fever, rash, flu-like syndrome, joint pain, pruritus) predominate in patients receiving interleukin.

    Patients with pheochromocytoma, given the risk of developing vascular collapse,it is recommended to pre-insert alpha-blockers, patients with an increased risk of allergic reactions - preliminary treatment with glucocorticoids and / or antihistamines.

    Before the introduction of contrast medium, the body must be dehydrated.

    During the introduction, conditions for immediate intensive care are necessary.

    Proposals for a diet. You can adhere to the usual diet, but in the last 2 hours before the study should refrain from eating.

    Consumption of liquid. Before and after the intravascular injection of the drug or its administration under the membranes of the brain, an adequate amount of fluid should be consumed. This is of particular importance for patients with multiple myeloma, diabetes mellitus, polyuria, hyperuricemia, as well as for infants, young children and patients in old age.

    Newborns (less than 1 month) and small children (1 month-2 years). Infants (up to 1 year) and especially newborns are characterized by sensitivity to electrolyte imbalance and hemodynamic disorders.Attention should be paid to the dose of the contrast agent, the technical support of the radiological study and the condition of the patient.

    The preparation, as a low osmolar water-soluble contrast agent, is used in routine gastrointestinal examinations in newborns, infants and older children due to the fact that this category of patients has an increased risk of aspiration, intestinal obstruction and penetration of contrast material from the lumen of the gut into the abdominal cavity.

    Fear. In the presence of a state of excitement, fear and pain, the risk of side effects or the intensity of reactions caused by a contrast agent may increase. Such patients can be prescribed sedatives.

    Pre-heating the contrast preparation before use. The contrast medium, heated before administration to body temperature, is better tolerated and easier to administer because of a decrease in the viscosity of the solution. Heated in a thermostat to 37 ° C follows only the amount of the drug that is supposed to be used. When protecting from daylight, heating for a longer period does not change the chemical purity of the drug, but the period of more than 3 months should not be exceeded.

    Carrying out a preliminary test.The use of a small amount of contrast agent for the sensitivity test is not recommended, since it has no prognostic significance. Moreover, carrying out such testing alone can lead to serious adverse reactions.

    Hypersensitivity. Sometimes after the use of non-ionic radiopaque agents such as yopromide, allergic hypersensitivity reactions or other manifestations of idiosyncrasy from the side of the cardiovascular, respiratory system and skin are observed. Usually, these reactions, the severity of which can be moderate to severe, including shock, occur within one hour after the administration of the contrast agent. However, in rare cases, deferred reactions (from hours to days) may develop.

    In patients with a known hypersensitivity to the drug or any of its components or with a previous hypersensitivity reaction to some other iodine-containing contrast medium, there is an increased risk of developing hypersensitivity reactions, which requires a particularly careful weighing of the benefit / risk ratio.

    Impact on the ability to drive vehicles and manage mechanisms

    It is not recommended to drive vehicles or work with any other mechanisms within the first 24 hours after administration of contrast media.

    Instructions
    Up