Yopromide TR - instructions for use, dose, side effects, contraindications

Active substanceYopromideYopromide

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Dosage form: & nbspinjection

Composition:

Per 1 ml of the preparation:

Solution for injection 300 mg iodine / ml

active substance: iopromide 623.40 mg (in terms of iodine 300.00 mg);

Excipients: trometamol 2.42 mg, sodium calcium edetate 0.10 mg, hydrochloric acid to a pH of 7.25 ± 0.25, water for injection to 1 ml.

Solution for injection 370 mg iodine / ml

active substance: iopromide 768.86 mg (in terms of iodine 370.00 mg);

Excipients: trometamol 2.42 mg, sodium calcium edetate 0.10 mg, hydrochloric acid to a pH of 7.25±0.25, water for injection up to 1 ml.

Description:

Transparent, colorless, light yellow liquid.

Pharmacotherapeutic group:radiopaque

ATX: & nbsp

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

Pharmacodynamics:

Physico-chemical characteristics of the preparation:

Concentrations of iodine (mg / ml)	300	370
Oresin content (mOsm / kg H₂О) at a temperature of 20 ° С	570-750	750-920
Viscosity (mPa-s)
at a temperature of 20 ° C	8,9	22,0
at a temperature of 37 ° C	4,7	10,0
Density (g / cm2)³) at a temperature of 20 ° C	1,250-1,380	1,340-1,480
PH value	6,5-8,0	6,5-8,0

Pharmacodynamics:

Yopromide (molecular weight - 791.12) is a non-ionized, low-osmolar, triiodinated radiopaque (isophthalic acid derivative), which increases the contrast of the image due to the absorption of X-rays by iodine included in its composition.

Pharmacokinetics:

Distribution

Yopromide after intravascular injection is very quickly distributed in the intercellular space. The half-life in the distribution phase is 3 minutes.

The connection with plasma proteins at the concentration of 1.2 mg iodine / ml is 0,9±0,2%. Yopromide can not penetrate through the intact blood-brain barrier, but in a small amount passes through the placental barrier.

1-5 minutes after bolus intravenous administration of iopromide 300 mg iodine / ml in blood plasma, 28±6% of its administered amount, regardless of the dose.

Metabolism

After the administration of iopromide in clinically acceptable doses, its metabolites were not detected.

Excretion

The excretion of iopromide in patients with normally functioning kidneys is characterized by a half-life of about 2 hours irrespective of the dose. When yopromide is used in doses recommended for diagnostic purposes, only glomerular filtration takes place. 30 minutes after the administration of yopromide by the kidneys, approximately 18% of the administered dose is excreted, after 3 hours - 60%, and after 24 hours - 92%, respectively. The total clearance with a high (370 mg iodine / ml) dose is 103 ml / min.

Dysfunction of the liver and kidneys

In patients with terminal stage of renal failure, non-ion radiopaque agents can be eliminated by hemodialysis. Dysfunction of the liver does not affect the excretion of the drug, since within 3 days only 1.5% of the administered dose is released through the intestine.

Indications:

The drug is intended for diagnostic purposes only!

It is used to enhance image contrast in CT, arteriography and venography, including intravenous / intra-arterial digital subtraction angiography (CSA); for intravenous urography, endoscopic retrograde cholangiopancreatography (ERHPG), arthrography and studies of other body cavities.

Solution for injection 370 mg iodine / ml

Has special advantages for angiocardiography.

Injection solutions 300 mg iodine / ml and 370 mg iodine / ml it is not recommended to use for study of subarachnoid space.

Contraindications:

There are no absolute contraindications.

Hypersensitivity to iopromide, iodine preparations or other auxiliary component of the drug.

Carefully:

These warnings and precautions refer to all routes of administration of radiopaque means, but the noted risk is higher with its intravascular management.

- Thyroid dysfunction.

- Elderly age.

- Severe condition of the patient.

Intravascular administration

Renal damage

Nephrotoxicity caused by radiocontrast agents, which is a transient impairment of kidney function, may occur after administration of the drug. In rare cases, acute renal failure may develop.

Risk factors:

- kidney failure;

- dehydration;

- diabetes;

- multiple myeloma / paraproteinaemia;

- administration of iopromide in repeated and / or high doses.

Cardiovascular diseases

In patients with severe heart disease or severe coronary artery disease, the risk of developing clinically significant changes in hemodynamics and arrhythmia is increased.

In patients with valvular heart disease and pulmonary hypertension, administration of an X-ray contrast agent can lead to severe hemodynamic disturbances.

Reactions involving ischemic changes in the electrocardiogram (ECG) and severe arrhythmias are most common in elderly patients and in patients with a history of cardiac pathology.

Intravascular injection of radiocontrast can cause pulmonary edema in patients with heart failure.

Diseases of the central nervous system (CNS)

In patients with a history of seizures or other diseases of the central nervous systemC the risk of seizures or neurological complications associated with the administration of the drug may be increased.

Pheochromocytomaa

In patients with pheochromocytoma, there is a risk of developing a hypertensive crisis. Premedication with alpha-blockers is recommended.

Patients with autoimmune diseases

The cases of severe vasculitis or Stevens-Johnson syndrome in patients with a history of autoimmune diseases are described.

Myasthenia gravis

The introduction of iodine-containing radiopaque substance may increase the severity of symptoms of myasthenia gravis.

Alcoholism

An acute or chronic form of alcoholism can increase the permeability of the blood-brain barrier. The facilitated penetration of X-ray contrast material into the brain tissue can lead to reactions from the CN sideC.

Introduction to other body cavities

Pregnancy should be excluded before hysterosalpingography.

Inflammation of the bile duct or tubal can increase the risk of reaction after ERCP or hysterosalpingography.

Pregnancy and lactation:

The drug should not be used in pregnant women, except when the intended benefit to the mother from its use exceeds the potential risk to the fetus, and such a study is appointed by the doctor, as necessary.

Excretion of the drug iopromide with breast milk is negligible and it is unlikely that it would pose a risk to infants.However, if you need to administer the drug, the mother should stop breastfeeding for at least 24 hours after the test.

Dosing and Administration:

General information

Before use, the drug should be heated to body temperature.

Before administration, you should carefully inspect the bottle. If the integrity of the vial is violated, a significant change in color, the detection of visible particles (including crystals), the drug should not be used. Because the iopromide is a highly concentrated solution, crystallization (the appearance of milk-like turbidity and / or precipitation or crystals in the form of a slurry) can occur extremely rarely.

For the introduction of a radiopaque solution, it is necessary to use an automatic injector or other special instruments with preservation of sterility. Recruit iopromide in a syringe or infusomat follows immediately before administration.

Do not make more than one puncture of the rubber stopper in order to prevent a large number of microparticles from entering the prepared solution from the plug. Therefore, for piercing the rubber plug and a set of radiopaque means, it is recommended to use cannulas with long tips with a diameter of no more than 18 G (best suited are marked cannulae with a lateral opening of the type Nocore-Admix).

Unused after opening the bottle the drug can be used within 10 hours after the first opening. Then it should be destroyed.

Doses for intravascular injection

The intravascular injection of the radiopaque means, if possible, is best carried out while the patient is lying down.

In patients with severe renal and cardiovascular insufficiency, as well as with the overall poor health status, the dose of radiopaque should be as low as possible. In such patients, it is recommended that kidney function be monitored for at least 3 days after the examination.

The dose of radiopaque means should correspond to the age, body weight to be solved by the clinical problem and the research method. Doses given below should be considered only as recommended; they are the usual dose for an average adult person with a body weight of 70 kg. The dose is expressed in ml for a single injection or per kg of body weight.

As a rule, doses up to 1.5 g of iodine per kg of body weight are usually well tolerated.Between individual injections, the body should be given sufficient time to leave the fluid from the interstitial space to normalize the increased serum osmolality. If necessary, in some cases, to exceed the total dose of 300-350 ml in adults, the introduction of water and, possibly, electrolytes is indicated.

Recommended doses for single injections

Ordinary angiography

View research	Dosage of the drug (iodine concentration mg / ml)	Dose, ml
Angiography of the arch of the aorta	300	50-80
Selective angiography	300	6-15
Breast aortography	300/370	50-80
Abdominal aortography	300	40-60
Arteriography:
Upper limbs	300	8-12
Lower limbs	300	20-30
Angiocardiography:
Ventricles of the heart	370	40-60
Coronary angiography	370	5-8
Venography:
Upper limbs	300	15-30
Lower limbs	300	30-60

Intravenous CSA

For the treatment of large vessels, use of the drug Yopromide TP 300 mg iodine / ml and Yopromide TP 370 mg iodine / ml in a volume of 30-60 ml. The drug is administered bolus at a rate of 8-12 ml / s to the ulnar vein or at a rate of 10-20 ml / s through the catheter into the vena cava. The time of contact between the radiopaque substance and the vein wall can be shortened by the rapid bolus injection immediately after the preparation with a 0.9% solution of sodium chloride.

Adults

30-60 ml solution of the preparation Yopromide TP 300 mg iodine / ml and Yopromide TP 370 mg iodine / ml.

Intraarterial CSA

When performing intraarterial CSA, in contrast to conventional angiography, smaller amounts of Yopromide TP and its lower concentrations can be administered.

CT scan (CT)

If possible, Iopromide TP should be injected into the vein as a bolus using an automatic injector. Only with slow scanning, about half the dose should be administered bolus, and the rest for 2-6 minutes to ensure a relatively constant concentration of the drug in the blood.

Spiral CT and especially multilayer CT allows a large amount of data to be obtained with one breathing delay. To obtain the optimal diagnostic effect of intravenously administered bolus (80-150 ml of injection for 300 mg of iodine / ml of the drug) in the study area (peak, time and duration of contrast), it is recommended to use an automatic injector and to monitor the time from the beginning of the introduction of radiopaque scanning.

Whole body CT

The necessary doses of radiopaque means and the speed of their administration depend on the organ under examination, the diagnostic problem being solved and, in particular, on the differences in scanning and the duration of image reconstruction.

CT of the skull

Adults

Yopromide TP 300 mg iodine / ml: 1.0-2.0 ml / kg;

Yopromide TP 370 mg iodine / ml: 1,0-1.5 ml / kg.

Intravenous urography

In connection with the physiologically weak concentration ability of immature kidney nephrons, children need relatively high doses of radiopaque.

The following doses are recommended Yopromide TR:

Age	Amount of iodine, g / kg body weight	Dose Yopromide TP, ml / kg body weight
	Amount of iodine, g / kg body weight	300 mg iodine / ml	370 mg iodine / ml
Newborns (<1 month)	1,2	4,0	3,2
Young children (1 month-2 grams)	1,0	3,0	2,7
Dchildren (2-11 years)	0,5	1,5	1,4
Adolescents and adults	0,3	1,0	0,8

If necessary, in some cases, adults may increase these doses.

Snapshot Time

Duration of pictures after administration of the drug Yopromide TP 300 mg iodine / ml Yopromide TP 370 mg iodine / ml with a duration of 1-2 minutes for the kidney parenchyma 3-5 minutes, for visualization of the renal pelvis and ureter system - 8-15 minutes after the beginning of the introduction of radiopaque substance.

The younger the patient, the earlier the picture is taken. Usually, you should take the first picture 2-3 minutes after the introduction of radiopaque. In newborns, infants and patients with impaired renal function, taking pictures at a later date can improve the visualization of the urinary tract.

Doses when administered to the body cavity

When carrying out arthrography, ERCP, the introduction of an X-ray contrast agent should be carried out under the control of fluoroscopy.

Recommended doses for individual studies

The dose can be highly dependent on age, body weight, general condition of the patient, as well as on the clinical problem being solved, the technical equipment used and the field of examination. Below are the average doses recommended to adults in the norm.

Arthrography: 5-15 ml of the drug Yopromide TP 300 mg iodine / ml / Iopromide TP 370 mg iodine / ml.

ERCPR: The dose depends on the clinical problem being solved and the size of the visualized structure.

Other cavities: The dose depends on the clinical problem being solved and the size of the visualized structure.

Side effects:

Side effects in the case of intravascular application of iodine-containing radiopaque substances are usually of a transient nature. However, severe and life-threatening reactions also occur.

Most often, with intravascular application, there are: nausea, vomiting, erythema, pain and a feeling of heat.

Side effects for all indications

Systems bodies	Often (≥1/100)	Sometimes (≥1/1000, <1/100)	Rarely (<1/1000)
Immune system disorders		Anaphylactoid reactions / hypersensitivity	Anaphylactic shock (including fatal cases)
Disorders from the endocrine sistems			Changes in thyroid function, thyrotoxic crisis
Violations from the nervous systems		Dizziness, anxiety	Paresthesia / hypnosis, confused consciousness, fear, agitation, amnesia, speech impairment, drowsiness, unconsciousness, coma, tremor, convulsions, paresis / paralysis, cerebral ischemia / infarction, stroke, transient cortical blindness
Disturbances on the part of the organ of sight		Blurred vision / vision impairment	Conjunctivitis, lacrimation
Violations by the body hearing			Hearing impairment
Heart Disease		Arrhythmia	Heart palpitations, chest pain / feeling of restraint, bradycardia, tachycardia, cardiac arrest, heart failure, myocardial ischemia / myocardial infarction, cyanosis
Vascular disorders		Vascular expansion	Increased blood pressure, lower blood pressure, shock. vasospasm, thromboembolism
Disturbances from the respiratory system		Sneezing, coughing	Rhinitis, shortness of breath, swelling of the mucous membranes, bronchial asthma, dysphonia, swelling of the larynx / pharynx of the tongue / face, bronchospasm, spasm of the larynx / pharynx, pulmonary edema, respiratory failure, respiratory arrest
Disturbances from the gastrointestinal tract	Nausea	Vomiting, taste disorder	Throat irritation, dysphagia, salivary gland swelling, stomach pain, diarrhea
Disturbances from the skin and subcutaneous tissues		Urticaria, itching, rash, erythema	Vascular Edema, Stephen-Johnson Syndrome, Lyell's Syndrome)
Disorders from the kidneys and urinary tract ways		Impaired renal function	Acute kidney failure
Are common disorders and disorders at the site of administration	Feeling of heat or pain, headache	Malaise, chills, increased sweating, fainting	Pallor, changes in body temperature, swelling, local pain, slight fever and swelling, inflammation and tissue damage in the case of extravasal administration

ERCPR

In addition to the listed undesirable effects in carrying out ERCP, it is possible to increase the activity of pancreatic enzymes (often), the development of pancreatitis (rarely).

Overdose:

When studying acute toxicity in animals, there was no risk of acute intoxication after application of the drug Yopromide TP.

Intravascular guidance

Symptoms: may include a violation of the balance of fluid and electrolytes, renal Mr.insufficiency, complications from the cardiovascular system and lungs. It is necessary to monitor the volume of fluid, the content of electrolytes, the function of the kidneys.

Treatment: should be aimed at maintaining vital body functions. Yopromide TP can be removed from the body by hemodialysis. In case of erroneous excess of the dose with intravascular injection of the drug into the human body, it is necessary to compensate for the loss of water and electrolytes by infusion. It is necessary to observe the kidney function for at least 3 days.

If necessary, hemodialysis can be used to infer the main parts of radiocontrast substance from the human body.

Interaction:

Biguanides (metformin): in patients taking biguanides, with intravascular injection of yopromide, it is possible to accumulate biguanides and develop lactic acidosis.To prevent this complication, you should stop taking biguanides 48 hours before the radiocontrast study and do not renew it for at least 48 hours after the introduction of the radiopaque. Resume their reception should only after the restoration of kidney function.

Simultaneous use of neuroleptics and antidepressants can reduce the convulsive threshold, increasing the risk of reactions associated with the use of radiopaque.

Patients taking beta-blockers may be resistant to drugs that have a beta-agonist effect, used to treat hypersensitivity reactions.

Interleukin-2: the risk of developing delayed reactions in response to the administration of yopromide increases with the preliminary treatment (within a few weeks) of patients with interleukin-2.

Effect on diagnostic tests

Radioisotopes: within a few weeks after the administration of Yopromide, there is a decrease in the absorption of thyrotropic isotopes by the thyroid gland, which reduces their effectiveness for diagnosis and treatment of thyroid diseases.

Special instructions:

Diet suggestions

You can adhere to the usual diet, but in the last 2 hours before the study should refrain from eating.

Fluid consumption

Before and after intravascular injection of the drug Yopromide TP, an adequate amount of fluid should be consumed. Of particular importance this has for patients with multiple myeloma, diabetes mellitus, polyuria, hyperuricemia, as well as to infants, small children, patients in advanced age.

Newborns (< 1 months) and small children (1 month-2 g)

Infants (up to 1 g) and especially newborns are characterized by sensitivity to disturbance of the water-electrolyte balance and hemodynamic disorders. Attention should be paid to the dose of radiopaque, technical support of radiological examination and the condition of the patient.

Yopromide, as a low osmolar water-soluble radiocontrast agent, is used in routine gastrointestinal (GI) studies in newborns, infants and older children due to the fact that this category of patients has an increased risk of aspiration, intestinal obstruction and penetration of the radiopaque substance from lumen of the intestine into the abdominal cavity.

Fear

In the presence of a state of excitement, fear and pain, the risk of side effects or the intensity of reactions caused by radiopaque means may increase. Such patients can be prescribed sedatives.

Preheating of radiopaque preparation before application

Radiopaque means, heated before administration to body temperature, is better tolerated and easier to administer because of lower viscosity of the solution. Heated in a thermostat to 37 ° C follows only the amount of the drug that is supposed to be used.

Conducting a preliminary test

The use of a small amount of radiopaque for carrying out the sensitivity test is not recommended, since it has no prognostic significance, moreover, carrying out such testing alone can lead to serious side reactions.

Hypersensitiveocthe

Sometimes after the use of incomplete radiopaque agents such as Yopromide TP, allergic reactions of hypersensitivity or other manifestations of idiosyncrasy from the side of the cardiovascular, respiratory system and skin are observed.Usually, these reactions, the severity of which can be moderate to severe, including shock, occur within one hour after the introduction of radiopaque. However, in rare cases, deferred reactions (from hours to days) may develop.

Patients with hypersensitivity or with previous reactions to iodine-containing radiopaque agents have an increased risk of developing severe reactions. However, such reactions are rare and unpredictable.

The risk of developing allergic reactions is increased in the following cases:

- in the presence of previously existing reactions to iodine-containing radiopaque agents;

- if there is an anamnesis of bronchial asthma or other allergic diseases.

Patients with severe cardiovascular diseases have increased risk development of severe or even fatal side effects.

In connection with the possibility of developing severe hypersensitivity reactions after the administration of radiopaque, after the end of the procedure, it is necessary to observe the patient's condition.

In all cases, it is necessary to be prepared, if necessary, to provide emergency care to the patient.

In case of hypersensitivity reactions, the administration of the radiopaque agent should be stopped immediately and, if necessary, started adequate therapy, preferably intravenously. Therefore, it is advisable to use a flexible catheter for intravenous radiocontrast. In order to be able to take emergency measures in emergency cases, it is necessary to have appropriate medicines, an endotracheal intubation tube and an apparatus for artificial ventilation.

It should be noted that patients taking beta-blockers may be resistant to the treatment of hypersensitivity reactions with drugs that have a beta-agonist effect. Caution is needed when using iodine-containing radiocontrast agents in patients receiving beta-blockers.

When conducting premedication, it is recommended to use glucocorticosteroids.

Thyroid dysfunction

Particularly careful weighing of the risk / benefit ratio follows in patients with established or suspected hyperthyroidism or goiter, since iodine-containing radiopaque agents can cause them to have hyperthyroidism or a thyrotoxic crisis.Consideration should be given to the need to evaluate the function of the thyroid gland prior to the administration of the drug Yopromide TP and / or prescribe thyreostatic therapy for preventive purposes in patients with established or suspected hyperthyroidism.

Age

Vascular pathology and neurological disorders, usually found in older people, increase the risk of adverse reactions to iodine-containing radiopaque agents.

Severe patient condition

The need for the study should be especially carefully evaluated in patients with a severe general condition.

Renal damage

In all patients who are administered iopromide, adequate rehydration should be provided prior to administration of the radiopaque, preferably by intravascular infusion before and after the procedure until the radiopaque means is excreted by the kidneys.

Before excretion of the radiopaque agent by the kidneys, it is necessary to exclude the additional burden on the kidneys in the form of nephrotoxic drugs, oral cholecystography, restriction of arterial blood flow in the kidney, angioplasty of the renal arteries, extensive surgical interventions, etc.

It should be postponed a new study with the introduction of radiopaque means before the restoration of kidney function to the baseline.

In patients on hemodialysis, the injected radiocontrast agents are removed from the body during hemodialysis.

Diseases of the central nervous system

The presence of intracranial tumors or metastases, as well as epilepsy, can increase the incidence of convulsive episodes after the introduction of radiopaque preparation. Neurological complications occur more often when performing cerebral angiography or similar studies.

Alcoholism

Care must be taken when conducting a study in patients with alcoholism and drug addiction due to the possibility of reducing the convulsive threshold.

Angiography

One of the properties of nonionic radiopaque substances is their extremely small impact on the normal physiological functions of the body. That is why non-ionic radiopaque substances have less anticoagulant activity in vitro, than ionic ones. A number of factors in addition to the properties of the radiopaque means, such as the duration of the study, the number of injections, the properties of the catheter and the syringe,state of the disease and ongoing treatment, can affect the development of thromboembolic complications. Therefore, during the catheterization of the vessel it is necessary to take into account these factors and pay special attention to the performance of the angiography technique, and also to wash the catheter with 0.9% sodium chloride solution (if necessary with the addition of heparin) and minimize the time of this procedure in order to minimize the risk of thrombosis and embolism.

The use of plastic syringes instead of glass can reduce, but not eliminate the possibility of blood clotting in vitro.

Caution is needed in the study of patients with homocystinuria due to the risk of thrombosis and embolism.

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

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

Form release / dosage:Solution for injection, 300 mg iodine / ml and 370 mg iodine / ml.

Packaging:

Solution for injection 300 mg iodine / ml. For 20, 50 or 100 ml of the drug in bottles of colorless glass, corked with rubber stoppers and crimped with aluminum caps.

For hospitals, 10 bottles, along with instructions for medical use, are placed in a cardboard box.

Solution for injection 370 mg iodine / ml. For 50 or 100 ml of the drug in bottles of colorless glass, corked with rubber stoppers and crimped with aluminum caps.

For hospitals 10 vials together with instructions for medical use and placed in a carton box.

Storage conditions:

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

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003110

Date of registration:21.07.2015

Date of cancellation:2020-07-21

The owner of the registration certificate:Tiarex, LLCTiarex, LLC Russia

Manufacturer: & nbsp

MOSFARM, LLC

Information update date: & nbsp13.11.2015

Illustrated instructions

Instructions

Yopromide TP (IOPROMIDE TR)