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

Yogexol is a nonionic low-osmolar iodine-containing radiopaque preparation. X-ray contrasting of articular cavities, uterine cavity, fallopian tubes, peritoneal protrusions, pancreatic and bile ducts,the bladder is reached immediately after administration.

Pharmacokinetics:

Almost 100 percent (%) of intravenously administered yogexol is excreted unchanged through normally functioning kidneys within 24 hours. The maximum concentration of iohexol in urine is determined approximately 1 hour after the injection.

The half-life of the drug in patients with normal renal function is about 2 hours. No metabolites of the drug were found. The binding of yogexol to plasma proteins is small (less than 2%) and has no clinical significance.

Indications:

Yogexol is intended only for diagnostic purposes.

The drug is used in the following diagnostic studies: cardioangiography, arteriography, urography, phlebography, radiopaque enhancement in computed tomography (CT), arthrography, endoscopic retrograde pancreatography (ERGG), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography, sialography and gastrointestinal intestinal tract (GIT).

Contraindications:

Hypersensitivity to the components of the drug, expressed thyrotoxicosis.

Carefully:

- If there is a history of allergy, asthma or other undesirable reactions to iodine-containing radiopaque agents. Premedication with glucocorticosteroids or antihistamine drugs is recommended.

- In the study of patients with severe cardiovascular diseases and pulmonary hypertension due to the risk of developing hemodynamics or arrhythmias.

- In the study of patients with acute cerebral pathology, tumors or epilepsy in an anamnesis, in connection with the predisposition of this category of patients to convulsions. The risk of seizures and neurological reactions is also increased in patients who suffer from alcoholism or drug dependence.

- In the study of patients with severe combined disorders of the liver and kidneys, as they significantly reduced the clearance of radiopaque means.

- In the study of patients at high risk for patients with impaired renal function, diabetes mellitus, patients with paraproteinaemia (myelomatosis and Waldenstrom macroglobulinemia). To prevent the development of acute renal failure after the introduction of radiopaque means such patients require special attention.

- When examining patients with thyrotoxicosis, especially patients with multinodular goiter (because of the risk of developing hyperthyroidism). With the introduction of radiopaque means for premature infants, the possibility of transient hyperthyroidism should be considered.

- In the study of patients with hypovolemia. It is necessary to provide adequate hydration of at least 100 ml every hour for 4 hours before the test and 24 hours after the test.

- In the study of patients with multiple myeloma, diabetes mellitus, impaired renal function, newborns, children under one year old and elderly patients. It is necessary to conduct adequate hydration before and after the introduction of radiopaque.

- When examining patients with diabetes, receiving metformin. Before intravascular administration of yogexol, the drug should be discontinued for at least 48 hours before and within 48 hours after the procedure.

In emergency cases, when the kidney function is unknown, the doctor should evaluate the risk / benefit ratio of using radiopaque: stop using metformin, hydrate, monitor kidney function, monitor the appearance of signs of lactic acidosis.

- In the study of patients with pheochromocytoma.It is necessary to preventive administration of alpha-adrenoblockers to prevent the development of hypertensive crisis.

- In the study of patients with multiple sclerosis, sickle cell anemia, obliterating thromboangiitis (Buerger's disease), acute thrombophlebitis, severe atherosclerosis.

- When angiography is performed in patients with homocystinuria, chronic lung emphysema - the risk of thrombosis and embolism.

- When performing urography in patients with severe renal dysfunction and patients with concomitant liver and kidney disease.

Pregnancy and lactation:

Studies on the safety and efficacy of Yogexol in pregnant and lactating mothers have not been conducted. The drug should not be used in pregnant women unless the intended benefit to the mother from its use outweighs the potential risk to the fetus and such a study is prescribed by the doctor as necessary.

Yoghexol is excreted in breast milk to a small extent, so you should refrain from breastfeeding for 24 hours after drug administration.

Dosing and Administration:

General information

The drug is intended for intravascular (intra-arterial, intravenous), intracavitary administration, oral administration and rectal administration.

Yogexol must be inspected visually before use for lack of insoluble particles, discoloration, and packaging integrity problems.

Yoghexol should be injected into the syringe immediately before use. The drug is intended for single use, unused remnants of the drug must be destroyed.

Do not mix Yogexol with other medicines (you need to use a separate syringe and needle).

It should be borne in mind that the radiopaque remedy is better tolerated if it is heated to body temperature.

When the drug is administered, the patient should be in a horizontal position. Within 30 minutes after the end of the procedure, the patient is monitored physically, since most adverse reactions occur during this period. Preparation of the patient, the procedure for administering the drug, measures for the prevention of adverse reactions are described in Section "Special instructions" of this manual.

Recommended dosing regimen

Intravenous administration

Urography

Adults - 40-80 ml (concentration of iodine 300 mg / ml or 350 mg / ml). In some cases, more than 80 ml can be used.

Children with a body weight of less than 7 kg:

- 3 ml / kg body weight (iodine concentration 300 mg / ml) or

- 4 ml / kg of body weight (concentration of iodine 240 mg / ml).

Children with a body weight of more than 7 kg:

- 2 ml / kg body weight (iodine concentration 300 mg / ml) or

- 3 ml / kg of body weight (concentration of iodine 240 mg / ml).

The volume of the injected drug is not more than 40 ml.

Phlebography of lower extremities

Adults - 20-100 ml per leg (concentration of iodine is 240 mg / ml or 300 mg / ml).

Digital subtraction angiography

Adults - 20-60 ml per injection (concentration of iodine 300 mg / ml or 350 mg / ml).

CT scan

Adults:

- 100-250 ml (concentration of iodine 240 mg / ml) or

- 100-200 ml (concentration of iodine 300 mg / ml) or

- 100-150 ml (concentration of iodine 350 mg / ml).

The total amount of iodine is usually 30-60 g.

For children:

- 2-3 ml / kg of body weight (concentration of iodine 240 mg / ml) or

- 1-3 ml / kg of body weight (concentration of iodine 300 mg / ml).

The volume of the injected drug is not more than 40 ml. In rare cases, you can apply up to 100 ml per child, but no more.

Intraarterial administration

Arteriography

Aortic arch

Adults - 30-40 ml per 1 injection (concentration of iodine 300 mg / ml).

Selective cerebral arteriography

Adults - 5-10 ml per 1 injection (concentration of iodine 300 mg / ml).

Aortography

Adults - 40-60 ml per 1 injection (concentration of iodine 350 mg / ml).

Femoral arteriography

Adults - 30-50 ml per injection (concentration of iodine 300 mg / ml or 350 mg / ml).

Other studies

Adults - a drug with an iodine concentration of 300 mg / ml (the amount to be administered depends on the type of study).

Cardioangiography

Adults

Left ventricle and aorta root - 30-60 ml per 1 injection (concentration of iodine 350 mg / ml).

Selective coronary angiography - 4-8 ml per 1 injection (concentration of iodine 350 mg / ml).

Children - Depending on the age, weight and pathology of the drug with an iodine concentration of 300 mg / ml or 350 mg / ml (maximum 8 ml / kg body weight).

Digital subtraction angiography

Adults - 1-15 ml per injection (concentration of iodine 240 mg / ml or 300 mg / ml).

Depending on the site of injection, it is sometimes possible to use large volumes of up to 30 ml.

Intracavernal administration

Arthrography

Adults - 5-20 ml (concentration of iodine 240 mg / ml) or 5-15 ml (concentration of iodine 300 mg / ml) or 5-10 ml (concentration of iodine 350 mg / ml).

ERCP / ERGG

Adults - 20-50 ml (concentration of iodine 240 mg / ml)

Gerniography

Adults - 50 ml (concentration of iodine 240 mg / ml). The volume to be administered depends on the size of the hernia.

Hysterosalpingography

Adults - 15-50 ml (concentration of iodine 240 mg / ml) or 15-25 ml (concentration of iodine 300 mg / ml).

Sialografiya

Adults - 0.5-2 ml (concentration of iodine 240 mg / ml or 300 mg / ml).

Studies of the gastrointestinal tract

Orally

Adults - The volume of the administered dose is selected individually (concentration of iodine 350 mg / ml).

Children (esophagus) - 2-4 ml / kg of body weight (concentration of iodine 300 mg / ml or 350 mg / ml). The total amount of administration should not exceed 50 ml.

Preterm infants - 2-4 ml / kg of body weight (iodine concentration 350 mg / ml).

Rectal

Children - 5-10 ml / kg of body weight (concentration of iodine 350 mg / ml). Before administration, the preparation should be diluted with water to an iodine concentration of 100-150 mg / ml.

CT scan

Yogexol (concentration of iodine 300 mg / ml or 350 mg / ml) is diluted with water to an iodine concentration of about 6 mg / ml.

Orally

Adults - the volume of the injected solution is 800-2000 ml.

Children - the volume of the administered solution is 15-20 ml / kg body weight.

Rectal

Children - The volume of the solution is chosen individually.

Side effects:

Common Adverse Reactions

Undesirable and adverse reactions to non-ionic radiopaque agents are usually of a moderate degree of severity, reversible and less common than with ionic radiopaque agents. Serious reactions, as well as cases with a fatal outcome, are extremely rare.

Adverse reactions to radiopaque substances in patients with allergies occur twice as often.Anaphylactoid reactions can occur regardless of the dose and mode of administration; A serious side effect can begin with minor manifestations of hypersensitivity reactions. In this case, it is necessary to immediately stop the introduction of radiopaque and start, if necessary, appropriate therapy.

When assessing the frequency of occurrence of various adverse reactions, the following grades are used: very often -10% and more often; often - 1-10%; infrequently, 0.1-1%; rarely 0.01-0.1%; very rarely, rarely 0.01%.

Often:

a feeling of heat all over the body; "metallic taste" in the oral cavity; from digestive system - nausea, vomiting, diarrhea.

Infrequently:

from of cardio-vascular system vasovagal reactions in the form of lowering blood pressure and tachycardia; hypersensitivity reactions from respiratory system - shortness of breath, bronchospasm or from skin - urticaria, rash, erythema, pruritus (allergic manifestations can occur immediately after the administration of the drug, and several days later), severe skin reactions in the form of Stevens-Johnson syndrome or toxic epidermal necrolysis.

Rarely:

from digestive system - a feeling of discomfort or pain in the abdomen; severe hypersensitivity reactions - laryngeal edema, pulmonary edema and anaphylactic shock; other reactions - iodism ("iodine pig", expressed in the increase and soreness of the salivary glands and can manifest up to 10 days after the study), hypothermia; "tides" of blood to the face.

Rarely:

cases with a fatal outcome (the main cause of cardiac arrest in patients with cardiovascular diseases).

Intravascular administration (intra-arterial and intravenous)

The nature of adverse reactions observed during intra-arterial administration of radiocontrast agents depends on the site of injection and dose. With selective angiography and other studies, when the radiopaque preparation enters the body under examination at a high concentration, there may be abnormalities in the functions of this organ. The frequency of serious adverse reactions is higher in cardioangiography.

Often:

Pain along the vessel or a feeling of heat, especially when peripheral angiography; from of cardio-vascular system - Arrhythmias with intravenous digital subtraction angiography; from central nervous system hallucinations in the form of light flashes cerebral angiography, pain in the legs when phlebography (usually small and short); from urinary system - impaired renal function (a transient increase in serum creatinine has no clinical significance, but patients in the high-risk group described severe manifestations, up to a lethal outcome).

Often:

from of cardio-vascular system - arrhythmias, angina / chest pain; decrease in blood pressure, bradycardia, tachycardia during cardioangiography; from central nervous system - Visual impairment, headache, perversion of taste, transient ischemic impairment of cerebral circulation, ischemic stroke with intraarterial digital subtraction angiography in patients from the high-risk group; from digestive system - nausea.

At the injection site, local soreness and radicular pain can be felt.

Infrequently:

from of cardio-vascular system - heart failure, asystole, lowering of arterial pressure, bradycardia, tachycardia, vasovagal reactions; from central nervous system - dizziness, anxiety, fever, motor and speech dysfunction, seizures, paresthesia, drowsiness, stiff neck, hemiparesis, fainting, tremor, transient ischemic stroke, ischemic stroke, nystagmus; from urinary system - transient proteinuria; from respiratory system - dyspnoea, rhinitis, cough, laryngitis; from digestive system - vomiting; from skin - urticaria, purpura, abscess, itching

Thyrotoxicosis may develop.

Patients at risk for thyrotoxicosis should be carefully examined before using iodinated radiocontrast.

Rarely:

from urinary system - transient oliguria or anuria; from digestive system - diarrhea, indigestion, dry mouth.

Rarely:

from urinary system - Renal failure.When injected into the coronary, cerebral or renal arteries, an arterial spasm can develop that leads to transient ischemia in the organ being examined.

From the side of cardio-vascular system - severe reactions in the form of rhythm disturbances, reduction of myocardial contractility or myocardial ischemia.

From the side central nervous system - convulsions, transient disorders of sensitivity or motor function. In isolated cases, the contrast agent can penetrate the blood-brain barrier, resulting in the accumulation of the drug in the cerebral cortex, which allows visualization of brain tissue with CT. This phenomenon can persist during the day following the research, sometimes accompanied by a transient disruption of orientation in space or cortical blindness.

Development of post-venereal thrombophlebitis or thrombosis.

Single cases of arthralgia are described.

Adverse reactions with intracavitary injection

General hypersensitivity reactions develop extremely rarely.

Endoscopic retrograde pancreatocholangiography:

Often:

sensation of pain and burning; from of cardio-vascular system - Increased blood pressure; from the central nervous system - drowsiness; from the digestive system - vomiting, diarrhea, increased intra-abdominal pressure.

There is a slight increase in the activity of amylase in the blood serum.

Rarely:

cases of pancreatic necrosis.

Oral reception:

there may be gastrointestinal disorders (diarrhea, nausea, vomiting, abdominal pain).

Hysterosalpingography (GHA):

Often:

moderate and transient pain in the lower abdomen.

Often:

from central nervous system - drowsiness, fever; from digestive system - nausea.

Arthrography:

After doing the test, you may experience a feeling of bursting and pain at the injection site.

Often:

swelling, pain, burning sensation at the injection site.

Infrequently:

the appearance of a hematoma at the injection site, muscle weakness.

Rarely:

the development of arthritis for the administration of the drug. There is a risk of developing infectious arthritis.

Gerniography:

Often:

from digestive system - Flatulence.

Often:

moderate pain reaction after the study; from central nervous system - headache, general malaise; from digestive system - diarrhea.

The extravascular introduction of radiopaque preparations (extravasation) can lead to the development of local pain and swelling, which usually pass without any consequences. Cases of inflammation and even tissue necrosis are described. As a routine therapeutic measures recommended cold and elevated position of the limb. In the case of development of compression symptoms, surgical decompression is recommended.

Overdose:

Overdose is unlikely in patients with normal renal function. In the case of high doses, the duration of the study (the half-life of the drug is approximately 2 hours) has a large effect on the kidneys.

Symptomscyanosis, bradycardia, acidosis, pulmonary hemorrhage, cardiac arrest, insomnia or drowsiness, weakness, fatigue, stupor, epileptic syndrome, coma, mental disorders (hallucinations, depersonalization, fear, disorientation, echolalia, depression, amnesia, psychosis, amblyopia , diplopia, photophobia), hyperesthesia, visual,auditory or speech disorders, changes in the electroencephalogram (EEG), meningism, hyperreflexia or areflexia, hemiplegia, paralysis, tetraplegia, tremor, cerebral hemorrhages.

In cases of overdose, measures should be taken to correct the water-electrolyte balance that has occurred. For the next three days, kidney function should be monitored.

There is no specific antidote; treatment is symptomatic, it is possible to conduct hemodialysis.

Treatment: diazepam 10 mg, intravenously slowly, 20-30 minutes after the cessation of convulsive seizure - intramuscularly phenobarbital 200 mg. Control and maintenance of vital functions, the conduct of symptomatic therapy.

Interaction:

Use of radiocontrast agents in patients with diabetes mellitus taking biguanides (metformin) can lead to a transient disruption of kidney function and the development of lactic acidosis. 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 or skin reactions).

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

Pharmaceutically, the drug is incompatible with the drugs of other groups.

Phenothiazine derivatives and other antipsychotic drugs (antipsychotics), monoamine oxidase inhibitors, tricyclic antidepressants, central nervous system stimulants, analeptics, antipsychotic drugs reduce the epileptic threshold and increase the risk of epileptic seizures.

Beta-adrenoblockers and other antihypertensive drugs increase the likelihood of developing arterial hypotension.

It enhances the nephrotoxic properties of other drugs.

Special instructions:

The drug is not intended for intrathecal administration.

Preparation of the patient and the procedure for administering the drug

Before applying radiopaque, you need to obtain accurate information about the patient, including laboratory data (including serum creatinine, an electrocardiogram, an allergy history or 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 multiple myeloma, diabetes, polyuria or gout, as well as newborns, children under one year, and elderly patients. 2 hours before the procedure, the patient should stop eating.

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 severe hypersensitivity reactions.

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

The risk of developing severe adverse reactions to the drug is small, but iodine-containing radiopaque agents can cause anaphylactoid reactions or other manifestations of hypersensitivity.

For this reason, it is necessary to foresee the sequence of medical measures in case of their occurrence and to have the necessary drugs and equipment for immediate medical care.

It is recommended to always install a cannula or catheter to ensure rapid intravenous access throughout the radiographic procedure.

Compared with ionic preparations, non-ionic radiopaque agents less influence in vitro on the blood coagulation system. When carrying out angiographic studies, one should carefully follow their methodology and often flush the catheters (for example, 0.9% solution of sodium chloride with the addition of heparin), minimize the duration of the procedure to minimize the risk of thrombosis and embolism associated with the intervention.

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

All iodine-containing radiopaque agents distort the results of thyroid radioisotope studies (iodine-binding capacity of the thyroid tissue remains reduced within 2 weeks after administration).

High concentrations of radiocontrast in blood plasma or urine can influence the results of biochemical tests to determine the concentration of bilirubin, proteins or inorganic substances (for example, 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 their reception after complete stabilization of kidney function.

Measures for the prevention of adverse reactions

- Identification of patients at high risk.

Ensuring adequate hydration of the patient, if necessary, by continuous intravenous infusion, started before the administration of the drug and continuing until it is excreted by the kidneys.

- Prevention of an additional burden on the kidneys arising from the use of nephrotoxic drugs, oral medicines for cholecystography, renal artery compression, angioplasty of the renal arteries, or extensive surgical operations, prior to removal of radiopaque material from the body.

- Repeated radiopaque studies should be performed no earlier than when the kidney function is restored to its original level.

- In patients with impaired renal and hepatic function, the clearance of the drug can be significantly reduced.

- Patients on hemodialysis can be given radiopaque agents provided dialysis is performed immediately after the examination.

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

Delayed reactions to intravascular injection of iodine-containing radiocontrast agents are rare. However, driving or working with other mechanisms is not recommended within the first 24 hours after the research.

Form release / dosage:

Solution for injection, 240 mg iodine / ml, 300 mg iodine / ml and 350 mg iodine / ml.

Packaging:

To 20, 50, 100 ml in bottles from colorless neutral cast glass of the first hydrolytic class (type I EP or USP), sealed with stoppers of chlorobutyl rubber and crimped with aluminum-plastic caps or caps of the combined type KP-2-20- "V-M".

200 ml in bottles of colorless cast glass of the first hydrolytic class (type I EP or USP), ukuporennye stoppers from chlorobutyl rubber and crimped caps aluminum-plastic.

To 20 ml in bottles from a tube of neutral transparent glass of the first hydrolytic class (type I EP or USP), sealed with stoppers of chlorobutyl rubber and crimped with aluminum-plastic caps or caps of the combined type KP-2-20- "V-M".

6 or 25 bottles of 20 ml, 10 bottles of 50 ml, 6 or 10 bottles of 100 ml, 6 bottles of 200 ml, together with instructions for use in an amount equal to the number of bottles, placed in a box of cardboard.

Storage conditions:

In a place protected from light and secondary X-ray radiation, at a temperature not exceeding 30 ° С.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002119

Date of registration:02.07.2013

Expiration Date:02.07.2018

Date of cancellation:2018-07-02

The owner of the registration certificate:Firm VIPS-MED, LLC Firm VIPS-MED, LLC Russia

Manufacturer: & nbsp

Firm VIPS-MED, LLC Russia

Information update date: & nbsp28.11.2017

Illustrated instructions

Instructions

Yogexol (Iohexol)