Clinical and pharmacological group: & nbsp

Radiopaque means

Included in the formulation
  • Telebriks® 30 meglumine
    solution in / in v / vesular 
    Gerbe     France
  • Telebriks® 35
    solution in / in 
    Gerbe     France
  • АТХ:

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

    Pharmacodynamics: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.
    Pharmacokinetics:
    After intravascular injection, the drug is distributed in the bloodstream and interstitial space.
    The drug is not metabolized and is rapidly excreted through the kidneys in an unchanged form by glomerular filtration.
    The volume of distribution in women 7.2 liters, in men 10 liters; total clearance 95,4 ml / min and 101 ml / min, renal clearance 89,4 ml / min and 94,9 ml / min, for women and men respectively.
    The initial phase of rapid spread with a half-life of 13.1 minutes (in women) and 23.5 minutes (in men) passes into the elimination phase with a half-life of 102 minutes (in women) and 137 minutes (in men).
    The connection with plasma proteins is negligible.
    In patients with renal insufficiency, the drug can be excreted through alternative routes - mainly through the bile ducts, and in small amounts - through the salivary, sweat glands.
    Indications:

    Radiographic examination:

    - intravenous urography,

    - CT scan,

    - digital angiography;

    - angiocardiography (ventriculography, coronary angiography).

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

    Contraindications:

    Hypersensitivity. Thyrotoxicosis.

    Contraindicated use in myelography.

    Carefully:

    Allergic reactions or history of bronchial asthma, dehydration, especially due to kidney disease, severe vascular disease, chronic heart failure, diabetes mellitus or in elderly patients, hyperthyroidism, immunodeficiency or autoimmune disorders, pheochromocytoma, hypersensitivity to iodine-containing contrast media in history, severe disorders renal function, sickle-cell anemia, homocystinuria, local infections, severe tissue ischemia, phlebitis,thrombosis, venous stasis, systemic venous obstruction, chronic emphysema, hepatic insufficiency, myeloma, elderly and children, pregnancy, breast-feeding.

    Pregnancy and lactation:

    The category of recommendations is not defined. Adequate and well-controlled studies in animals and in humans have not been carried out. The drug should not be used in pregnant women, except when the intended benefit to the mother from its use outweighs the potential risk to the fetus.

    Such a study is appointed by the doctor because of necessity.

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

    Dosing and Administration:

    The dose is chosen taking into account the age, body weight, vessel size and blood flow velocity.

    Ventriculography: 40 ml per injection (average).

    Coronary angiography: from 4 to 8 ml per injection.

    The examination should be performed in a state of fasting and after the serum creatinine assay to adjust the dose in patients with suspected renal dysfunction.

    Side effects:

    Symptoms on the part of the respiratory system: cough, a feeling of tightness in the chest.

    Symptoms from the gastrointestinal tract: nausea, vomiting.

    Sensorine symptoms: feeling of heat, anxiety, agitation, headache.

    Skin symptoms: itching, localized or generalized urticaria, skin rash, edema of the eyelids.

    Following these mild to moderate degrees of adverse reactions, or simultaneously with them, more serious ones may occur.

    Allergic reactions: shortness of breath, lower blood pressure, less often - anaphylactic shock, bronchospasm, laryngeal edema, pulmonary edema and, in exceptional cases, angioedema.

    Cardiovascular symptoms: rhythm disorders, profuse sweat, pallor, cyanosis, in exceptional cases - heart failure and cardiovascular collapse, thromboembolism, angina pectoris, myocardial infarction, hypertensive crisis, pseudoaneurysms, bleeding at the puncture site, coronary artery dissection, ischemia, arterial thrombosis.

    Disturbances of ventilation: shortness of breath, swelling of the larynx, bronchospasm.

    Neurological disorders: tetany, convulsions, cerebral edema, coma.

    Other: thyrotoxic crisis, hemolysis, loss of organ function.

    Accidental entry of a contrast agent into the tissue surrounding the vessel can cause local soreness and an inflammatory response.

    Overdose:After administration of large doses of the drug, patients who are in a state of dehydration, or after the administration of a large total dose, cases of acute renal failure were observed. The functions of the basic vital organs should be restored by an emergency prescription of symptomaticabout the treatment. Violation of water-electrolytebalance can be compensated for by rehydration. It is recommended to monitor the parameters of kidney function for three days. If rehydration and other necessary measures are ineffective, oliguria and anuria may require hemodialysis.
    Interaction:

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

    The risk of developing a reaction to the administration of yoxythalamic acid (a skin rash or (more rarely) a decrease in blood pressure, oliguria and kidney failure)if a patient previously received intravenous therapy with interleukin-2.

    The combination of yoxythalamic acid with metformin requires caution. In patients with diabetes mellitus, a decrease in renal function caused by an X-ray examination may be a triggering factor in the development of lactic acidosis. Metformin should be temporarily discontinued 48 hours before and resumed only 2 days after the X-ray examination.

    In the case of development of shock or reduction in blood pressure with the introduction of iodine-containing contrast beta-adrenoblockers suppress compensatory reactions from the cardiovascular system.

    Before the X-ray examination, the use of beta-blockers should be stopped as far as possible. If continuity of therapy is extremely important for the patient, you should have appropriate resuscitation equipment at hand.

    If diuretics caused dehydration, it increases the risk of developing acute renal failure, especially when using large doses of iodine-containing contrast. Before the introduction of iodine-containing contrast, the patient should be rehydrated.

    Pharmaceutically incompatible with other drugs.

    Special instructions:

    Diagnostic procedures should be performed under the guidance of personnel with experience in their conduct.

    Yoksitalamovuyu acid can not be administered intralesistly (possible epileptic syndrome, intracerebral haemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, brain edema, death).

    If patients have hypersensitivity to iodine-containing contrast media, as well as allergies in the anamnesis, which should be clarified by interviewing the patient, it is desirable to perform a premedication, which is usually effective (although it can not always prevent severe reactions). Usually premedication includes administration of antihistamines, glucocorticosteroids and, in some patients, fibrinolysis inhibitors (aminocaproic acid).

    Currently, premedication is not considered necessary for all patients, as the percentage of adverse reactions is relatively small.

    With intra-arterial administration, its rate should be equal to the rate of blood flow in the injected vessel.

    When developing during the introduction of side effects, the injection should be stopped immediately.

    During and for 30-60 minutes after intravascular administration of yoxythalamic acid, monitoring of possible severe adverse reactions by personnel trained in emergency care is required.

    The department requires the presence of equipment for ECG monitoring and anti-shock installation, containing epinephrine and oxygen, and the conditions for immediate intensive therapy in the development of possible hypersensitivity reactions.

    In all cases, up to (may continue until the administration of yoxitalamic acid) and after the examination adequate oral or intravenous hydration is recommended.

    When performing angiographic procedures, during the manipulation of the catheter and the introduction of a contrast agent, it is necessary to take into account the possibility of plaque rupture, damage or perforation of the vessel wall. It is necessary to carry out trial injections to check the correct location of the catheter.

    The introduction of iodine-containing radiocontrast agents may aggravate the symptoms of myasthenia gravis.

    With the introduction of the drug in patients with pheochromocytoma, the development of a hypertensive crisis is possible.

    The study is performed on an empty stomach.

    Impact on the ability to drive vehicles and manage mechanisms

    Perhaps the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, so care must be taken.

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