Gadodiamide (Gadodiamidum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Magnetic resonance contrast media

Included in the formulation
  • Gadodiamide
    solution in / in 
    JODAS EKSPOIM, LLC     Russia
  • Hadodiamide-TL
    solution in / in 
    TECHNOLOGY OF DRUGS, LTD.     Russia
  • Omniscan®
    solution in / in 
    JI Halskea Limited     United Kingdom
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    V.08.C.A   Paramagnetic contrast media

    Pharmacodynamics:Gadodiamide increases the contrast of the image during the magnetic resonance imaging in the following way. Gadolinium atoms are known to have paramagnetic properties and generate a local magnetic field. This field accelerates the reorientation of hydrogen in the water, induced by the magnetic field of the apparatus. High contrast in the study makes visualization of abnormal structures or formations in the central nervous system easier. It should be borne in mind that the results of the study are negative despite the existing pathological process (some types of differentiated malignant tumors and inactive plaques in multiple sclerosis, which are not subjected to contrast enhancement).
    Pharmacokinetics:The drug is administered intravenously. The half-life of the distribution is 3.7 minutes, mainly in the extracellular fluid.The volume of distribution is 200 ± 61 ml / kg (approximately equal to the volume of extracellular fluid). There was no binding to plasma proteins. Not subject to biotransformation. It is excreted by the kidneys with the help of glomerular filtration in unchanged form. For 77.8 minutes, 50% of the dose administered is eliminated. For 4 hours after intravenous injection in the urine is found about 85%, after 24 hours - 95.4% of the dose. The levels of plasma and renal clearance are almost identical and are 1.7 and 1.8 ml / min, respectively, which means the elimination of the drug with only the kidneys. It does not penetrate the unchanged blood-brain barrier, but if its permeability or disorders of cerebral circulation is impaired, it accumulates in pathological foci of the brain and spinal cord - tumors, zones of subacute strokes, abscesses and others, changing the intensity of the radio-frequency signal. The best contrast is provided in the first minutes after the introduction of the gadodiamide, the effect lasts about 45 minutes.
    Indications:The drug is used only for diagnostic purposes in contrast MRI studies of the brain and spinal cord.
    ICD-10

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

    Contraindications:Hypersensitivity to the drug; severe renal dysfunction (creatinine clearance less than 30 ml / min); pregnancy and lactation (for 24 hours after the procedure to stop breastfeeding); children under 6 months of age (safety not studied).
    Carefully:There have been reports of the development of nephrogenic systemic fibrosis due to the introduction of gadolinium-containing contrast agents, including gadodiamide, patients with moderate and mild renal impairment in the hepatorenal syndrome. Any blood diseases, including anemia, hemoglobinopathies and others. Lack of liver function. Weighed allergic anamnesis.
    Pregnancy and lactation:Do not use during pregnancy! The action category for the fetus by the FDA is C. There have not been well-controlled studies on humans. In animal experiments, the drug caused teratogenic and embryotoxic effects.

    Lactation: There is no data on the penetration of the drug into human milk. Stop breastfeeding for 24 hours after the procedure.

    Dosing and Administration:The aqueous solution of the gadodiamide contains 0.5 moles of the drug in 1 ml.

    Introduced intravenously bolusno, once.

    Adults with a body weight of up to 100 kg and children older than 6 months are given 0.2 ml / kg of body weight (i.e., 0.1 mol / kg). Adults with a body weight of more than 100 kg are given 20 ml intravenously struino.

    The study is carried out in a few minutes and within one hour (later informativity is questionable). Re-enter (if necessary) only when the clearance is normal.

    Application in elderly patients

    Use in the elderly has not been systematically studied. There is no data on the need to reduce the dosage of the drug in patients in this group, although due to age-related changes in the cardiovascular, respiratory, central nervous and other systems, this may be relevant.

    Use in children

    The drug in children is used from the age of 6 months in a dosage calculated for adults (0.1 mol / kg body weight).

    Side effects:Allergic reactions: itching, urticaria, erythematous eruptions and other skin manifestations like erythema, throat swelling, anaphylactoid reactions, idiosyncrasy.

    From the skin: bruising, redness of the face, sweating, discoloration of the skin.

    From the side of the central nervous system: dizziness, headache, ataxia and coordination disorders, fainting, tremors and convulsions up to a generalized epiprust, tinnitus, visual impairment, perversion and loss of taste.

    From the digestive tract: diarrhea, nausea, vomiting, abdominal pain.

    Urinary system: impaired renal function, acute renal failure.

    Change in laboratory indicators: asymptomatic change in serum iron level (8-48 hours after administration).

    At the injection site - local pain, a sense of compression.

    Overdose:There were no cases of overdose. The goals of therapy with a possible overdose are maintenance of vital functions, rapid administration of symptomatic therapy. Quick removal of the drug from the body with hemodialysis.
    Interaction:Pharmacologically incompatible with any other drugs.
    Special instructions:At the time of injection, dose fragmentation is avoided. Within a few hours after the procedure is carefully monitored the patient's condition - there is a possibility of development of severe complications (anaphylactic shock,seizures and other). Do not use the solution when changing its color and the appearance of large particles. Enter the drug should a doctor who has experience with paramagnetic contrast media.
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