Iopamidol - instructions for use, dosage, side effects, contraindications

Clinical and pharmacological group: & nbsp

Radiopaque means

Included in the formulation

Yopamidol

solution for injections

JODAS EKSPOIM, LLC Russia

Yopamiro

solution for injections

Brakko SpA Italy

Scanlux® 300

solution in / vessel.

Sanochemistry Pharmaceuticals AG Austria

Scanlux® 370

solution in / vessel.

Sanochemistry Pharmaceuticals AG Austria

АТХ:

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

Pharmacodynamics:

Radiopaque contrasting water-soluble iodine-containing agent. The molecule is non-ionic in nature, the solution has low osmotic pressure, which contributes to good local and systemic tolerance.

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. After intraluminal injection into the subarachnoid space, diffusing into cerebrospinal fluid, allows you to visualize the subarachnoid spaces of the brain and spinal cord. When instillation in the bladder, the kidneys, ureters, fallopian tubes allows you to visualize the internal structure of these organs.

Used as a contrast drug for intra-intralesional, intra-arterial and intravenous administration.

Pharmacokinetics:After intraloballyth introduction is distributed upstream cerebrospinal fluid, penetrates into the vagina of the roots of the spinal cord nerves and the narrowed regions subarachnoidallyth space. Also penetrates into the extracellular fluid of the brain and the soft medulla of the cerebral and cerebellum adjacent to the subarachnoidspace. With unchanged dynamics cerebrospinal fluid Eliminated from it into the blood for 1 hour. After intravenous administration, it is quickly distributed into the intercellular fluid. Clinically significant deposition in tissues does not occur. It does not penetrate the blood-brain barrier, but accumulates in the interstitial tissues of malignant brain tumors (due to changes in the permeability of the blood-brain barrier under the influence of the tumor). The connection with plasma proteins is insignificant.Half-life with intravascular injection of about 2 hours (with unchanged kidney function). Time to maximum contrast: with standard myelography - immediately after the administration, ≥ 30 minutes remain, with CT-myelography - 4 hours, with intravascular injection - 5-40 minutes, with urography - 5-15 minutes. TСmax after intravascularabout the introduction - immediately, but quickly decreases due to the distribution in the intercellular space. Elimination when intraloballym introduction: mainly kidney (29-100% of the dose in the form of unchanged substance for 48 hours); after intravascularabout the administration of mainly kidneys (35-40% of the dose in the form of unchanged substance for 1 hour, 80-90% of the dose - for 8 hours). If renal function is impaired, the elimination slows down depending on the degree of impairment.

Indications:Neuroradiology: myeloradiculografia, cisternography, ventriculography. Angiography: cerebral angiography, coronary angiography, thoracic aortography, aortography of the abdominal aorta, angiocardiographyI, selective visceral arteriography, peripheral arteriography, venography, digital subtraction angiography. Urography: intravenous urography, computed tomography.Arthrography: fistulography.

ICD-10

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

Contraindications:Hypersensitivitynost; macroglobulinemiaI Waldenstrom, multiple myeloma, hepatic and / or renal failure, severe thyrotoxicosis, epilepsy, decompensatedheart failure. In acute inflammatory diseases of the pelvic organs, hysterosalpingo is contraindicatedgraphy. When acute pancreatitis is contraindicated endoscopic retrograde cholangiopancreatitisography.

Carefully:Allergic reactions to penicillins or skin allergens in history, allergic reactions or bronchial asthma in history, dehydration, especially due to kidney disease, severe vascular disease, diabetes mellitus or in elderly patients; hyperthyroidism, pheochromocytoma, severe renal dysfunction, sickle cell anemia, chronic alcoholism, subarachnoidalhemorrhage, multiple sclerosis, local or systemic infections, unstable angina, cardiac pathology, severe pulmonary hypertension,widespread atherosclerosis, recent cerebral vascular embolism, severe hypertension, migraine, old age or recent thrombosis, homocystinuria, thromboangiitis obliterans, severe ischemia accompanied by ascending infection, anuria or diabetes mellitus, pulmonary emphysema, periarticular tissue infections.

Pregnancy and lactation:

Recommendations FDA Category B. Qualitative controlled studies in humans are not conducted. Possible development of fetal side effects observed in adults.

In pregnancy, the use of iodine-containing contrast medium is possible only in case of emergency, when the potential benefit for the mother justifies the potential risk to the fetus.

There is no information on the penetration into breast milk. However, since other contrast media penetrate into breast milk, it is recommended to temporarily stop breastfeeding within 24 hours after the administration of yopamidol.

Dosing and Administration:

Neuroradiology: 5-15 ml (200-300 mg iodine / ml).

Angiography: for cerebral angiography - 5-10 ml bolus (300 mg iodine / ml); for conducting coronary angiography, thoracic aortography,abdominal aortography, angiokardiografii - 1.0-1.2 mL / kg (370 mg iodine / ml); for conducting selective visceral arteriography - 300-370 mg iodine / ml; for peripheral arteriography recommended administration 40-50 ml (300-370 mg iodine / ml); for the conduct of venography recommended the introduction of 30-50 ml (300 mg iodine / ml); for digital angiography 1-15 ml (200 mg iodine / ml) or 40 mL bolus (300-370 mg iodine / ml).

Urography: recommended doses - 30-50 ml.

When conducting Computed Tomography - 0.5-2 ml / kg (300-370 mg iodine / ml) was intravenously bolus infusion or a combination of these two methods.

Arthrography: the recommended dose is 300 mg iodine / ml.

Side effects:

From the cardiovascular system: cardiotoxicity, ventricular tachycardia or ventricular fibrillation, cyanosis, bradycardia (1.3% of patients at angiokardiografii), hypotension, tachycardia, dilation of arterioles, thromboembolic complications, myocardial infarction and acute disorders of cerebral circulation.

From the respiratory system: bronchospasm or pulmonary edema, acute rhinitis or laryngeal edema, coughing, sneezing, shortness of breath, nausea and vomiting, loss of appetite, unusual gustatory sensations,

From the urinary system: urinary retention, temporary increase in the concentration of creatinine in the blood plasma, acute renal failure, anuria, oliguria, hematuria.

From the nervous system and sensory organs: headache, loss of consciousness, dizziness, irritation of the meninges, stiff neck, central neurotoxicity, drowsiness, increased eye photosensitivity, turbidity or other changes in vision, transient full amnesia.

From the musculoskeletal system: convulsive attacks, musculoskeletal disorders, involuntary movements, paresis of the lower extremities, back pain, pain or convulsive constriction of the lower limbs, stiff neck muscles, back pain.

Laboratory indicators: thrombocytopenia, anemia, a decrease in platelet aggregation, a decrease in the number of red blood cells and peripheral blood leukocytes.

Other: hyperemia of the skin, fever, fever, sweating, asthenia, rash, agitation, iodism, burning, soreness and bleeding at the injection site, pallor of the skin, hypersensitivity, including cross, pseudoallergic reactions, carcinogenicity or mutagenicity, increased dehydration,fever. If during an examination epileptic seizure develops - intravenously diazepam or phenobarbital sodium.

Overdose:Overdose can occur only in patients with severe renal failure. In the case of high doses, the drug can cause severe complications from the cardiovascular systemrespiratory systems and kidney function. There is no specific antidote, symptomatic treatment, it is possible to conduct hemodialysis.

Interaction:

β-Adrenoblockers - may increase the risk of moderate severity and severe anaphylactoid reactions and increase the hypotensive effect in parallel application; in patients with risk factors, it is recommended that β-blockers be discontinued before radiocontrast agents are introduced.

Tricyclic antidepressants, CNS stimulating agents (amantadine, amphetamines, bronchodilators, cocaine, caffeine, meropenem, local anesthetics, methylphenidate, selegiline, sympathomimetics, suppressing appetite supplements, theophylline, fluoroquinolones), MAO inhibitors (procarbazine, furazolidone), phenothiazine derivatives, trimeprazine - despite the absence of reports of combination with yopamidol, when combined with other nonionic radiopaque agents, the development of convulsive seizures may be possible due to the reduction of the convulsive threshold by these agents; it is recommended that these remedies be canceled 48 hours before and within 24 hours after myelography.

Hydralazine - increased risk of lupus-like syndrome with the administration of yopamidol to patients receiving hydralazine.

Interleukin-2 - may increase the frequency of delayed (after 1 hour after administration) reactions to radiopaque agents (hypersensitivity, fever, skin rashes, flu-like syndrome, pain in the joints, itching, vomiting, hypotension, dizziness) with parallel application; In severe cases, supportive therapy may be required; administration of radiopaque agents 6 weeks after the administration of interleukin-2 reduces the frequency of these reactions.

Nephrotoxic agents (aldesleukin, aminoglycosides (for parenteral administration or topically for damaged mucous membranes), amphotericin B (for parenteral use), amphotericin B liposomal, paracetamol (in high doses), paracetamol in combination with acetylsalicylic acid or other salicylates (with prolonged high-dosage therapy), acyclovir (for parenteral administration), bacitracin (for parenteral administration), vancomycin (for parenteral administration), deferoxamine (with prolonged use), ifosfamide, capreomycin, carmustine, methotrexate (in high doses), methoxyflurane, sodium calcium edetate (in high doses), neomycin (with oral administration), non-steroidal anti-inflammatory drugs, oxaliplatinum, gold preparations, lithium preparations, pamidronic acid, penicillamine, pentamidine, polymyxins (for parenteral use), radiocontrast iodine-containing water-soluble drugs (for intravascular administration), rifampicin, means for oral cholecystography, streptozocin, a combination of sulfamethoxazole and trimethoprim, sulfonamides (for systemic use), tacrolimus, tetracyclines (with the exception of doxycycline and minocycline), tretinoin, phenacetin, sodium foscarnet, ciprofloxacin, cisplatin, cyclosporin] - it is possible to increase the nephrotoxicity of yopamidol with intraluminal or intravascular administration with parallel application.

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 for up to 48 hours before the test and resume after complete stabilization of kidney function.

Drugs for oral cholecystography - may increase the risk of nephrotoxicity, especially if the liver function is impaired.

Blood pressure lowering agents [β-adrenoblockers, aldesleukin, alprostadil, amantadine, amifostine, general anesthetics, antidepressants, MAO inhibitors, tricyclic antidepressants, antihypertensives, benzodiazepines used for premedication, calcium channel blockers, brethil tosylate, bromocriptine, haloperidol, hydralazine, deferoxamine (at a dose of more than 15 mg / kg per day, administered intravenously), diuretics, droperidol, ACE inhibitors, cabergoline, calcium-containing infusion solutions, carbidopa, quetiapine, acid gadopentetovaya, clozapine, contrast agents paramagnetic, contrast agents superparamagnetic, levodopa, lidocaine (for systemic use), loxapine, magnesium sulfate (for parenteral administration), mirtazapine, molindone, narcotic analgesics, sodium calcium edetate, nitrates, nitrites, olanzapine, paclitaxel, pentamidine, pentoxifylline, pimozide, pramipexole, procainamide, propofol, protamine (with very rapid administration), ranitidine, bismuth citrate, radiocontrast water-soluble agents, organic iodides (for intravascular application), risperidone, rituximab, ropinirole, thioxanthenes, tizanidine, tokainid, tolcapone, thrombolytic agents, phenothiazines, quinidine, ethanol] - may increase the risk of severe hypotension with parallel application.

Pharmaceutically incompatible with the drugs of other groups. Incompatible (with intraluminal injection) with glucocorticoids.

Special instructions:

In patients with a history of convulsive seizures that do not receive anticonvulsant therapy, barbiturates may be premedicated before intraluminal administration. Patients receiving anticonvulsants can continue treatment during the administration of yopamidol.

When intramuscular injection should not be taken 2 hours before the study. Before this, it is possible to follow a normal diet.

If unintentional exposure to the skull cavity or an overdose of yopamidol, the appointment of anticonvulsants may reduce the risk of convulsive seizures.

It is not recommended to directly administer yopamidol to the cisterns and ventricles of the brain during standard radiologic procedures.

In carrying out myelography, patients should be in a supine position, with an elevated head at least 8 hours after the examination (the vertical position slows the dispersion of the drug and increases its absorption by the arachnoid shell of the lumbar region). Observe the usual bed rest for 24 hours. Do not bend the body and active movements for 24 hours after the test to avoid loss of cerebrospinal fluid.

Studies of yopamidol tolerance in children have not been conducted, but there has been an increased risk of severe side effects of radiocontrast agents in children, especially those suffering from bronchial asthma, allergic diseases, chronic renal insufficiency or a creatinine concentration in the blood plasma of more than 133 mmol / l or under 1 year of age.In newborns and infants (especially with polyuria, oliguria or dehydration), an increased risk of dehydration and / or kidney failure is possible. Appropriate hydration is recommended before and after administration of yopamidol. The factors limiting intravesical application of yopamidol in children are not determined. There are no data on intrauterine injection in children.

Differences in tolerability iopamidol elderly patients is not fixed, however, in the presence of polyuria, oliguria, diabetes or dehydration in elderly patients, may increase the risk of kidney failure, which requires adequate hydration before and after iopamidol. Furthermore, in the elderly are more common age-related renal failure, which may require dose reduction iopamidol, and enhanced sensitivity to the effects on thyroid function (yodindutsirovanny thyrotoxicosis may develop within 4-12 weeks after the indwelling Research); thyroid function monitoring may be required. The factors limiting intravesical or intrauterine administration in elderly patients are not determined.

It should avoid the use of equipment in which the drug may enter into direct contact with a metal surface containing Cu2 +.

In patients with thyrotoxicosis use of iodinated contrast agent is possible only in case of emergency. It will be appreciated that the capture of iodine in the thyroid gland will decrease in several days (and sometimes two weeks) after application of iodinated contrast agents.

When carrying out a spinal block, you need to remove as many injected contrast solution as possible.

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

Yopamidol (Iopamidolum)