Yopamidol (IOPAMIDOL)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceYopamidolYopamidol
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    • Dosage form: & nbspinjection
    Composition:

    1 ml of solution for injection contains:

    Dosage

    Active substance:

    200 mg iodine / ml

    300 mg iodine / ml

    370 mg iodine / ml

    Yopamidol

    408 mg

    612 mg

    755 mg

    Excipients:

    Trometamol

    1.0 mg

    1.0 mg

    1.0 mg

    Sodium calcium edetate

    0.26 mg

    0.39 mg

    0.48 mg

    Hydrochloric acid

    to pH 6.5-7.5

    to pH 6.5-7.5

    to pH 6.5-7.5

    Water for injections

    up to 1 ml

    up to 1 ml

    up to 1 ml
    Description:

    A clear, colorless or light yellow solution.

    Pharmacotherapeutic group:X-ray contrast medium
    ATX: & nbsp

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

    Pharmacodynamics:

    Yopamidol is a non-ionic, triiodinated, water-soluble radiocontrast agent. Has low osmotic pressure, which contributes to good local and systemic tolerance. Used as a contrast drug for intra-intralesional, intra-arterial and intravenous administration.

    Pharmacokinetics:

    Yopamidol is not metabolized, does not accumulate in the liver and is excreted chemically unchanged by glomerular filtration. Half-life in patients with normal renal function is about 2 hours, the creatinine clearance in these cases is from 60 to 146 ml / min, depending on age, gender and anthropometric parameters. After 24 hours Yopamidol almost completely eliminated from the body with urine.

    Yopamidol does not penetrate the blood-brain barrier, through the placental barrier - to an extremely small extent.

    In patients with impaired renal function, the half-life period is prolonged depending on the degree of kidney damage, the creatinine clearance in these cases is from 20 to 59 ml / min.

    Yopamidol does not bind to serum or plasma proteins.

    Indications:

    X-ray contrast agent for myeloradiculography, cisternography, ventriculography, cerebral and coronary arteriography, thoracic aortography, abdominal aortography, angiocardiography, selective visceral and peripheral arteriography, venography, digital angiography of cerebral,peripheral and abdominal arteries, intravenous urography, contrast enhancement in computed tomography, arthrography, fistulography.

    Contraindications:

    Hypersensitivity to yopamidol, iodine-containing radiopaque agents and auxiliary components of the drug, Waldenstrom's macroglobulinemia, multiple myeloma, severe hepatic and / or renal insufficiency, thyrotoxicosis, epilepsy, uncompensated heart failure. In acute inflammatory diseases of the pelvic organs, hysterosalpingography is contraindicated. In acute pancreatitis, endoscopic retrograde cholangiopancreatography is contraindicated.

    Carefully:

    Renal, hepatic and cardiovascular failure, emphysema, severe general condition, severe atherosclerosis, diabetes, requiring correction, subclinical hyperthyroidism, nodular goitre of mild and moderate severity, patients with a history of allergy, bronchospasm or other adverse reactions in the application iodine-containing radiopaque agents, patients with cardiovascular diseases and pulmonary hypertension,with bronchial asthma, pollinosis, sickle-cell anemia, multiple sclerosis, pheochromocytoma, acute thrombophlebitis, acute cerebral pathology, brain tumors, polyuria, oliguria, gout, alcoholism, drug addiction, myasthenia.

    Pregnancy and lactation:

    Data on the use of yopamidol in pregnancy are absent. Therefore, the drug should be used during pregnancy only in cases where the potential benefit to the mother justifies the potential risk to the fetus.

    Until now, the possibility of getting Yopamidol into the milk of a nursing woman has not been studied. After the introduction of the drug, breast-feeding should be stopped and its renewal is possible not earlier than 24 hours after the administration.

    Dosing and Administration:

    Preparation of the patient

    Before using the contrast agent, it is necessary to obtain accurate information about the patient, including laboratory data (including serum creatinine content, electrocardiogram (ECG), history of allergy, pregnancy).

    Prior to the study, the patient should eliminate disturbances in the water-electrolyte balance and ensure sufficient supply of fluid and electrolytes.This is especially true for patients with diabetes mellitus, polyuria, oliguria or gout, as well as newborns, infants and young children, elderly patients.

    2 hours before the procedure should refrain from eating. When the drug is administered, the patient should be in a horizontal position.

    Within 30 minutes after the end of the procedure, medical control of the patient is performed, since most side reactions occur precisely during this period.

    It is not recommended to perform preliminary testing of individual sensitivity with the use of small doses of the drug due to the risk of developing severe hypersensitivity reactions, as when using other iodine-containing contrast agents.

    Patients who are afraid of the procedure, it is desirable to introduce sedatives.

    Terms of use

    Before administration, the preparation must be heated to body temperature.

    Yopamidol is injected into a syringe or a vial of drip immediately before the procedure. The solution of the contrast agent is intended exclusively for single use, the rubber stopper of the bottle is pierced only once, the rest of the contrast agent is destroyed.For the introduction of contrast agent it is necessary to use a separate syringe and needle; do not mix it with other medicines.

    Recommended dosing regimen

    Indication / Examination

    Concentration of iodine (mg / ml)

    The recommended dose (ml)

    Method of administration: intravenously and intraarterially

    Myeloradiculography

    200

    5-15

    Cisternography and ventriculography

    200

    5-15

    Cerebral arteriography

    300

    5-10 (bolus)

    Coronary arteriography

    370

    8-15 (bolus)

    Breast aortography

    370

    1.0-1.2 / kg body weight

    Abdominal aortography

    370

    1, 0-1,2 / kg body weight

    Angiocardiography

    370

    1, 0-1,2 / kg body weight

    Selective visceral

    300

    1.0-1.2 / kg body weight

    arteriography

    370

    0,8-1,2 / kg of body weight

    Peripheral arteriography

    300-370

    40-50

    Digital subtraction

    200

    1-15

    angiography

    300-370

    40 (bolus)

    Venography

    300

    30-50

    Method of administration: intravenously and into the joint cavity

    Increase the contrast when

    300-370

    0.5-2.0 ml / kg

    computed tomography *

    body weight

    Arthrography

    300

    depending on the type of examination

    Fistulography

    300

    depending on the type of examination

    * To increase the contrast in scanners during CT, the drug can be administered as a bolus, or by drip infusion, as well as in a combination of these two methods.

    Intravenous urography:

    The drug is administered intravenously.

    Dosage 300, 370 mg iodine / ml

    Children

    1-2.5 ml / kg is proportional to the dose for adults, depending on body weight and age.

    Adults

    40-80 ml, with acute renal failure, the usual methods of dosing (up to 1.5 ml / kg of body weight)

    According to the other stated indications, the drug is used in children depending on body weight and age, except for coronary angiography and selective coronary arteriography. For examination of patients with impaired renal function, the most acceptable Yopamidol 370 mg / ml, which is characterized by the least pronounced osmotic diuresis.

    Side effects:

    Allergic reactions: acute rhinitis, laryngeal edema, skin reactions (rash, hives, itching), anaphylactic shock.

    Local reactions: pain at the injection site.

    From the nervous systemheadache, dizziness, drowsiness, agitation, topical / clonic convulsions, aphasia, syncope, temporary narrowing of the visual fields, hemiparesis, coma (developed in patients suffering from diseases of the central nervous system), temporary confusion, transient disruption of orientation in space or cortical blindness, perversion of taste, meningism, changes in EEG.

    From the skin: Stevens-Johnson syndrome.

    From the urinary system: acute renal failure, anuria, oliguria, hematuria.

    From the digestive system: nausea, vomiting, pain in the abdomen.

    From the cardiovascular system: peripheral vasodilation, severe arterial hypotension, arterial hypertension, tachycardia, dyspnea, cyanosis and loss of consciousness (may require urgent treatment), transient bradycardia, myocardial ischemia, ventricular arrhythmia, cardiac rhythm disturbance, decreased myocardial contractility, heart failure, ECG changes including segment depression ST), arterial thrombosis, post-venereal thrombophlebitis or thrombosis.

    From the side of the musculoskeletal system: neck neck stiffness, back pain, in some cases in patients with increased convulsive readiness or using psychotropic drugs with the introduction of the drug may occur spasms of skeletal muscles or generalized convulsions.

    From the respiratory system: cough, sneezing, bronchospasm, pulmonary edema.

    From the sense organs: itching in the eyes, lacrimation, conjunctivitis, photophobia, temporary hearing loss.

    Laboratory indicators: thrombocytopenia, anemia.

    Other: generalized sensation of fever, increased sweating, asthenia, pallor of the skin, fever, tremor, chills, chest pain, iodism, hyperthyroidism (in patients previously treated for Graves' disease).

    Overdose:

    Overdosing can occur only in patients with severe renal failure. In the case of high doses, the drug can cause severe complications from the cardiovascular, respiratory and renal functions. There is no specific antidote, the treatment is symptomatic; it is possible to conduct hemodialysis.

    Interaction:

    When used concomitantly with psychotropic drugs, analgesics and antidepressants yopamidol can reduce the convulsive threshold, increasing the risk of adverse reactions.

    Use of yopamidol in patients with diabetic nephropathy who take biguanides (metformin), can lead to a transient disruption of kidney function and the development of lactic acidosis. As a precaution, you should stop taking biguanides 48 hours before the test and resume after complete stabilization of kidney function.

    In patients taking beta-adrenoblockers, the manifestations of anaphylaxis with yopamidol can be atypical and mistaken for vagal reactions.

    Patients who took less than 2 weeks before the study of interleukin-2 are prone to an increased incidence of delayed adverse reactions (flu-like conditions, rash).

    Special instructions:

    Before each use of radiopaque means, it is necessary to obtain accurate information about the patient, including important laboratory data (including serum creatinine, ECG, allergy and pregnancy).

    Before the study, the patient should eliminate the disturbance of the water-electrolyte balance and ensure sufficient supply of fluid and electrolytes.

    2 hours before the procedure, the patient should stop eating.

    Patients who are afraid of waiting before the procedure need premedication with sedatives.

    It is forbidden to mix radiopaque with other medications.

    Hypersensitivity

    The risk of serious allergic reactions when using Yopamidol is low.Nevertheless, it is possible to develop anaphylactoid or other allergic reactions, which requires the availability of appropriate medications and equipment for resuscitation. It is desirable to use a permanent cannula or catheter for quick access to the vessel during the entire study. Premedication with glucocorticosteroids or antihistamine drugs is recommended.

    In the study of patients with diabetes mellitus, impaired renal function, newborns, children under one year and elderly patients, adequate rehydration should be performed before and after the administration of the radiocontrast. Babies and especially newborns are sensitive to disturbance of water-electrolyte balance and changes in hemodynamics.

    In neurological studies

    In the case of cerebrospinal blockade when the drug is administered, as much as possible of the injected contrast solution should be removed.

    In cases of the presence of blood in the cerebrospinal fluid, the physician should carefully evaluate the necessary need for a diagnostic procedure taking into account the risk to the patient.

    In angiographic studies

    When performing angiographic studies, one should carefully follow their technique and often flush the catheters (for example, 0.9% sodium chloride solution with heparin addition) to minimize the risk of thrombosis and embolism associated with the intervention.

    Patients undergoing angiocardiographic procedures should pay special attention to the state of the right heart and pulmonary circulation. The introduction of an organic iodine-containing solution in the absence of right heart and pulmonary hypertension can cause bradycardia and arterial hypotension. Increased caution should be observed when introducing a contrast agent in the right heart cavity of newborns with pulmonary hypertension and impaired cardiac function.

    When contrasting the arch of the aorta in a number of cases, it is possible to develop arterial hypotension, bradycardia.

    With peripheral arteriography with the drug at a dosage of 370 mg / ml, pain in the examined extremity can sometimes occur. Usually this is not observed when using a less concentrated solution - 300 mg / ml.

    When prescribing the drug to patients who are to study the function of the thyroid gland, it should be borne in mind,that the absorption of iodine by the tissues of the thyroid gland decreases for a period of up to 2 weeks, which may affect the results of the study.

    High concentrations of radiocontrast in blood and urine can affect the results of biochemical tests to determine the concentration of bilirubin, proteins or inorganic substances (eg, iron, copper, calcium and phosphates). Therefore, such tests should not be performed on the day of the study.

    It is necessary to stop taking biguanides 48 hours before the test and resume after complete stabilization of kidney function. Repeated radiopaque studies should be performed no earlier than when the kidney function is restored to its original level.

    Care should be taken in patients with severe combined disorders of the liver and kidneys, as they have significantly reduced the clearance of radiopaque means.

    Performing radiopaque studies in patients on hemodialysis is possible, provided that dialysis will be performed immediately after the study.

    Effect on the ability to drive transp. cf. and fur:

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

    Form release / dosage:Injection, 200 mg iodine / ml, 300 mg iodine / ml and 370 mg iodine / ml.
    Packaging:

    30 ml, 50 ml, 100 ml, 200 ml or 500 ml of the preparation of all dosages into a colorless glass bottle (Eur. Ph., Type I), sealed with a rubber stopper and crimped with an aluminum cap.

    For 1 bottle of the drug, together with the instruction, but the application is placed in a cardboard box.

    Storage conditions:

    In a place protected from light and secondary X-rays, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002846
    Date of registration:29.01.2015
    Expiration Date:29.01.2020
    Date of cancellation:2020-01-29
    The owner of the registration certificate:JODAS EKSPOIM, LLC JODAS EKSPOIM, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspJodas Expoim, Open CompanyJodas Expoim, Open Company
    Information update date: & nbsp29.11.2017
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