Iodixanol - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Radiopaque means

Included in the formulation

Visipac®

solution for injections

JI Halskea Limited United Kingdom

Iodixanol

solution for injections

JODAS EKSPOIM, LLC Russia

АТХ:

V.08.A Radiocontrast iodine-containing substances

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. After intravascular injection, the blood vessels are consistently contrasted, allowing visualization of their internal structure before the onset of significant hemodilution.

Pharmacokinetics:97% is excreted in the urine in 24 hours, 2% - through the gastrointestinal tract. The concentration in the plasma is maximal at the time of intravascular injection and decreases rapidly (in 5-10 minutes) iodixanol passes into the extravascular space. The half-life is 2 hours in healthy patients, increases (up to 24 hours) if the excretory function of the kidneys is disturbed.

Indications:For intra-arterial administration: selective cerebral arteriography,selective cerebral intra-arterial digital subtraction arteriography, aortography, peripheral arteriography, peripheral intra-arterial digital subtraction arteriography, cardioangiography. For intravenous administration: intravenous excretory urography, venography of extremities. Contrast enhancement in X-ray computed tomography.

ICD-10

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

Contraindications:Hypersensitivity(including other iodine-containing drugs); chronic renal, hepatic, cardiac failure in the stage of decompensation, severe thyrotoxicosis, dehydration, acute violations of liver and kidney function, pregnancy, breast-feeding (after the study is suspended for 2 days), children's age.

Carefully:Allergic reactions or bronchial asthma in history, dehydration, especially due to kidney disease, severe vascular disease, chronic heart failure, diabetes mellitus or in elderly patients, hyperthyroidism,immunodeficiency or autoimmune disorders, pheochromocytoma, hypersensitivityto history of iodine-containing contrast media, sickle cellanemia, homocystinuria, local infections, severe tissue ischemia, phlebitis, thrombosis, venous stasis, systemic venous obstruction, chronic emphysema, myeloma, elderly age.

Pregnancy and lactation:

FDA recommendation category B.

In pregnancy iodixanol apply in cases of extreme necessity. During lactation, breastfeeding should be discontinued before the introduction of radiopaque and resumed no earlier than 24 hours after administration.

Hysterosalpingography should not be performed in pregnant women and in the presence of acute pelvic peritonitis.

Dosing and Administration:

Individual, depending on the type of study, age, body weight, cardiac output, the general condition of the patient, and the research technique used.

Necessary dilutions - 270-320 mg / ml - are prepared in physiological saline. For cerebral arteriography, 5-10 ml of solution is used, with aortography and urography - 40-60 ml, with computed tomography - 50-150 ml.

Side effects:

From the digestive system: nausea, vomiting, and taste disorders are possible.

From the side of the central nervous system: visual impairment, headache.

Allergic reactions: skin rash, itching, angioedema, cases of anaphylactic shock are described.

From the cardiovascular system: arterial hypotension, bradycardia. When injected into the coronary, cerebral or renal arteries, an arterial spasm can develop, leading to transient ischemia of the corresponding organs. It is possible to increase blood pressure, severe cardiovascular disorders in the form of rhythm disturbances, reducing myocardial contractility or myocardial ischemia. Postphlebographic thrombophlebitis or thrombosis may occur.

Other: transient violations of kidney function, visual impairment, arthralgia, complaints of pain in the distal limbs. Parotitis (iodine pig) is possible for the administration of the drug, which is expressed in the increase and soreness of salivary glands with a duration of up to 10 days after administration.

Local reactions: feelings of heat, cold, discomfort at the injection site are possible.

Laboratory indicators: a transient increase in creatinine in the blood, but it usually has no clinical significance.

Overdose:

It manifests as nausea, vomiting, vascular collapse, impaired liver function, kidney function.

Treatment: symptomatic; hemodialysis is removed in 4 hours to 50%. The loss of water and electrolytes should be replenished with the help of infusion therapy. It should be monitored for kidney function for at least three days.

Interaction:

Means for general anesthesia - described a large number of side effects after iodixanol administration to patients under general anesthesia, possibly due to the impossibility of identifying the symptoms in patients and the hypotensive effect of anesthesia extending the duration of iodixanol.

Means for oral cholecystography - may increase the risk of nephrotoxicity, especially in patients with hepatic insufficiency, when administered shortly after intravascular injection of iodixanol.

Interleukin-2 is a recombinant human. Patients who took less than 2 weeks before the study of interleukin-2 are prone to an increased incidence of delayed adverse reactions (influenza-like conditions or skinreaction).

The use of iodixanol in patients with diabetic nephropathy receiving metformin, can lead to a transient disruption of kidney function and the development of lactic acidosis. As a precaution, it is necessary to stop the use of metformin 48 hours before the study and resume after complete stabilization of kidney function.

When applied simultaneously with antipsychotic drugs, analgesics and antidepressants iodixanol can reduce the convulsive threshold, increasing the risk of adverse reactions.

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

Special instructions:

It is necessary to strictly observe the compliance of the used dosage form with indications for use.

Do not dehydrate the body before adding contrast medium.

On the day of administration of iodixanol, the content of bilirubin, proteins, iron, copper, calcium, phosphates should not be determined in the blood plasma. Within 2 weeks after the application of iodixanol, the iodo-binding capacity of the thyroid tissue is reduced.

Use iodixanol is recommended in the presence of conditions for urgent measures in cases of development of serious adverse reactions, including anaphylactic shock.

Impact on the ability to drive vehicles and manage mechanisms

It is not recommended to drive vehicles or work with mechanisms that require increased concentration of attention, within 24 hours after the introduction of radiopaque means.

Instructions

Iodixanol (Iodixanolum)