Pharmacological properties of the drug Omnipaque
iohexol N,N-Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide,5-[acetyl(2,3-dihydroxypropyl)amino] -N,N-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide) is a nonionic triiodinated water-soluble radiocontrast agent. The values of osmolarity and viscosity of the drug are given in the table:
Iodine concentration, mg/ml | Osmolarity, osmol/kg H2O at 37 °C | Viscosity (mPa•s) at 20 °C | Viscosity (mPa•s) at 37 °C |
| 180 240 300 350 | 0,36 0,51 0,64 0,78 | 3,2 5,6 11,6 23,3 | 2,0 3,3 6,1 10,6 |
In a study of healthy individuals after intravenous injection of Omnipaque, no significant deviations were found in most hemodynamic parameters, clinical-biochemical parameters and coagulation parameters. The time to achieve maximum radiopacity with conventional myelography is up to 30 minutes (after 1 hour it is no longer visualized). With computed tomography (CT), visualization of contrast in the thoracic region is possible for 1 hour, in the cervical region - about 2 hours, in the basal cisterns - 3-4 hours. Contrast of joint spaces, the uterine cavity, fallopian tubes, peritoneal protrusions, pancreatic and bile ducts, bladder is achieved immediately after administration of the drug. Almost 100% of iohexol administered intravenously with normal renal function is excreted unchanged from the body in the urine within 24 hours. The maximum concentration of iohexol in urine is established 1 hour after injection. The half-life of the drug in patients with normal renal function is 2 hours. Metabolites of the drug have not been established. The binding of iohexol to plasma proteins has no clinical significance (less than 2%), and therefore may not be taken into account. When administered intrathecally, it is absorbed from the CSF into the bloodstream and completely excreted by the kidneys (about 88% during the first day). Renal clearance - 99 ml/min., total clearance - 109 ml/min. The maximum concentration in the blood is 119 mcg/ml, the time to reach the maximum concentration in the blood is 2–6 hours. The volume of distribution is 157 ml/kg. The half-life is 3–4 hours.
Use of the drug Omnipaque
For intravenous, intravenous, intrathecal, intracavitary, oral and rectal administration in adults and children. When administering the drug, the patient should be in a horizontal position. The dose of the drug depends on the type of study and its technique. There are no significant differences with other radiopaque agents, but you can focus on the following dosing methods: Intravascular administration
Indications | Iodine concentration, mg/ml | Volume | Comments |
| Urography | When performing high-dose urography, higher doses may be used | ||
| Adults | 300 or 350 | 40–80 ml | |
| Children ≤7 kg | 240 or 300 | 4–3 ml/kg | |
| Children 7 kg | 240 or 300 | 3–2 ml/kg (but not more than 40 ml) | |
| Arteriography | |||
| Aortography (arches) | 300 | 30–40 ml per injection | |
| Selective cerebral angiography | 300 | 5–10 ml per injection | |
| Aortography | 350 | 40–60 ml per injection | |
| Femoral angiography | 300 or 350 | 30–50 ml per injection | |
| Other types of angiography | 300 | Depending on the type of study | |
| Phlebography of the lower extremities | 240 or 300 | 20–100 ml per limb | |
| Cardioangiography | |||
| Adults Injection into the left ventricle and aortic root | 350 | 30–60 ml per injection | |
| Selective coronary angiography | 350 | 4–8 ml per injection | |
| Children | 300 or 350 | Depending on age, body weight and pathology | |
| Digital subtraction angiography | Depending on the injection site, larger volumes (up to 30 ml) may be used. | ||
| V/a | 240, 300 | 1–15 ml per injection | |
| IV | 300, 350 | 20–60 ml per injection | |
| Contrast enhancement at | |||
| Adults | 240,300, 350 | From 250, 200, 150 ml respectively | The total amount of iodine is usually 30–60 g |
| Children | 240 | 2–3 ml/kg body weight (up to 40 ml) | In some cases, it is possible to administer up to 100 ml |
| 300 | 1–3 ml/kg body weight (up to 40 ml) |
Subarachnoid injection
Indications | Iodine concentration, mg/ml | Volume | Comments |
| Myelography | |||
| Lumbar and thoracic (lumbar injection) | 180 or 240 | 10–15 and 8–12 ml respectively | Lumbar puncture |
| Cervical (lumbar injection) | 240 or 300 | 10–12 and 7–10 ml | Lumbar puncture |
| 240 or 300 | 6–10 and 6–8 ml, respectively | Lateral cervical puncture | |
| CT cisternography | 180 or 240 | 2–6 and 4–12 ml | Lumbar puncture |
| Myelography in children | |||
| Up to 2 years | 180 | 2–6 ml | |
| 2–6 years | 180 | 4–8 ml | |
| Over 6 years old | 180 | 6–12 ml |
To minimize the risk of side effects, the total dose of iodine should not exceed 3 g.
Intracavitary administration
Indications | Iodine concentration, mg/ml | Volume | Comments |
| Aortography | 240, 300, 350 | From 5 to 20.15, 10 ml respectively | |
| Endoscopic retrograde cholangiopancreatography | 240 | 20–50 ml | |
| Herniography | 240 or 300 | 50 ml | The volume of injection depends on the volume of the hernia |
| Hysterosalpingography | 240 or 300 | From 15 to 50, 25 ml respectively | |
| Sielography | — | 0.5–2 ml | |
| Gastrointestinal studies Oral administration | |||
| Adults | 180, 240, 350 | The choice is made individually | |
| Children | |||
| Esophagus | 300, 350 | 2–4 ml/kg body weight | |
| Stomach | 140 | 4–5 ml/kg body weight | |
| Premature babies | 350 | 2–4 ml/kg body weight | Maximum dose 50 ml |
| Rectal administration children | 140 or higher doses diluted with water to a concentration of 100–150 mg/ml | 5–10 ml/kg body weight | Example: dilute Omnipaque 240, 300 or 350 with water 1:1 and 1:2 |
| CT enhancement Oral contrast | Example: dilute Omnipaque 300 or 350 with water 1:50 | ||
| Adults | Dilute with water to a concentration of about 6 mg/ml | 800–2000 ml of solution over a certain period of time | |
| Children | Dilute with water to a concentration of about 6 mg/ml | 15/20 ml/kg body weight | |
| Rectal administration | Dilute with water to a concentration of about 6 mg/ml | Selected individually |
Omnipack 350 mg iodine/ml 50 ml 10 pcs. injection
pharmachologic effect
X-ray contrast agent.
Composition and release form Omnipak 350 mg iodine/ml 50 ml 10 pcs. injection
Solution - 1 ml:
- Active substance: Omnipaque® 350 mg iodine/ml: iohexol 755 mg;
- Excipients: trometamol 1.21 mg, sodium calcium edetate 0.10 mg, hydrochloric acid 5 M solution to pH 6.8-7.6 as required, water for injection up to 1.00 ml.
20 ml in a colorless glass bottle (Eur. Pharm., type I), sealed with a chlorobutyl rubber stopper and crimped with an aluminum cap, closed on top with a snap-off plastic cap.
25 bottles of 20 ml along with instructions for use are placed in a cardboard box.
50, 100, 200 or 500 ml in a bottle made of polypropylene PPM R021, sealed with a stopper made of chlorobutyl rubber and closed with a screw-on polypropylene cap, equipped with a ring at the bottom to ensure the first opening control, and at the top with a ring for tearing off the sealing gasket.
The 50 ml, 100 ml, 200 ml and 500 ml bottles have a label, the lower part of which is used to hang the bottle.
10 polypropylene bottles along with instructions for use are placed in a cardboard box.
Description of the dosage form
Transparent, colorless or slightly yellowish solution.
Characteristic
Non-ionic, monomeric, triiodinated, water-soluble radiocontrast agent. Sterile aqueous solution, colorless or slightly yellowish.
Directions for use and doses
General information
The drug is intended for intravascular (intraarterial, intravenous), intrathecal administration, intracavitary administration, oral administration and rectal administration. Like all drugs for parenteral administration, Omnipaque® must be visually inspected before use to ensure the absence of insoluble particles, color changes and damage to the integrity of the packaging.
Omnipaque® should be drawn into a syringe immediately before use. Unused remains of the drug are not allowed for further use.
Additional instructions for using the auto-injector
500 ml X-ray contrast media bottles should only be used in conjunction with the appropriate auto-injector. In this case, a single puncture of the bottle cap is performed. The outlet tube of the autoinjector is changed after each patient.
Unused drug remaining in the bottle and connecting tubes is destroyed at the end of the working day. If necessary, smaller vials can also be used. When working with an auto-injector, you must follow the instructions for its use.
Omnipaque® should not be mixed with other medications (it is necessary to use a separate syringe and needle).
Within 30 minutes after the end of the procedure, medical supervision of the patient is carried out, because Most adverse reactions occur during this period.
Intrathecal administration
After myelography, the patient should be in a horizontal position for 1 hour with his head and chest elevated by 20°. After which the patient can walk carefully, but should not bend over. If the patient remains in bed, his head and chest should remain elevated for 6 hours. If a low seizure threshold is suspected, the patient should remain under medical supervision during this period of time. Outpatients should not be left unobserved for the first 24 hours after administration of a radiocontrast agent.
The dosage of the drug depends on the type of study, the age and body weight of the patient, the state of hemodynamics, general health, as well as the methodology and technique used for performing the study. Typically, the same iodine concentrations and volumes of drug administration are used as when using other modern iodine-containing radiocontrast agents.
The recommended dosage regimen is shown in the table below:
| Indication/examination | Concentration | Volume | Notes | |
| Intravenous (IV) administration | ||||
| Urography | ||||
| Adults: | 300 mg iodine/ml or 350 mg iodine/ml | 40-80 ml 40-80 ml | In some cases, more than 80 ml can be used | |
| Children (body weight | 240 mg iodine/ml or 300 mg iodine/ml | 4 ml/kg 3 ml/kg | ||
| Children (body weight > 7 kg) | 240 mg iodine/ml or 300 mg iodine/ml | 3 ml/kg 2 ml/kg | Max. 40 ml | |
| Phlebography (lower limbs) | 240 mg iodine/ml or 300 mg iodine/ml | 20-100 ml per leg | ||
| Digital subtraction angiography | 300 mg iodine/ml or | 20-60 ml per 1 injection | ||
| 350 mg iodine/ml | 20-60 ml per 1 injection | |||
| CT scan | ||||
| Adults: | 240 mg iodine/ml or 300 mg iodine/ml or 350 mg iodine/ml | 100-250 ml 100-200 ml 100-150 ml | The total amount of iodine is usually 30-60 g | |
| Children: | 240 mg iodine/ml or | 2-3 ml per kg of weight no more than 40 ml | In rare cases, you can use up to 100 ml per child, but no more | |
| 300 mg iodine/ml | 1-3 ml per kg of weight no more than 40 ml | |||
| Intra-arterial (i.a.) administration | ||||
| Arteriography | ||||
| Aortic arch | 300 mg iodine/ml | 30-40 ml per 1 injection | The injection volume depends on the injection site | |
| Selective cerebral arteriography | 300 mg iodine/ml | 5-10 ml per 1 injection | ||
| Aortography | 350 mg iodine/ml | 40-60 ml per 1 injection | ||
| Femoral arteriography | 300 mg iodine/ml or 350 mg iodine/ml | 30-50 ml per 1 injection | ||
| Other | 300 mg iodine/ml | depends on the type of study | ||
| Cardioangiography | ||||
| Adults: | ||||
| Left ventricle and aortic root | 350 mg iodine/ml | 30-60 ml per 1 injection | ||
| Selective coronary angiography | 350 mg iodine/ml | 4-8 ml per 1 injection | ||
| Children: | 300 mg iodine/ml or 350 mg iodine/ml | depending on age, weight and pathology | Max. 8 ml/kg | |
| Digital subtraction angiography | 240 mg iodine/ml or | 1-15 ml per 1 injection | Depending on the injection site, sometimes larger volumes of up to 30 ml can be used | |
| 300 mg iodine/ml | 1-15 ml per 1 injection | |||
| Intrathecal administration | ||||
| Lumbar and thoracic myelography (lumbar injection) | 240 mg iodine/ml | 8-12 ml | ||
| Cervical myelography (lumbar injection) | 240 mg iodine/ml or 300 mg iodine/ml | 10-12 ml 7-10 ml | ||
| Cervical myelography (lateral cervical injection) | 240 mg iodine/ml or 300 mg iodine/ml | 6-10 ml 6-8 ml | ||
| CT cisternography (lumbar injection) | 240 mg iodine/ml | 4-12 ml | ||
| To minimize possible adverse reactions, the total dosage of iodine should not exceed 3 g | ||||
| Introduction to body cavities | ||||
| Arthrography | 240 mg iodine/ml or | 5-20 ml | ||
| 300 mg iodine/ml or | 5-15 ml | |||
| 350 mg iodine/ml | 5-10 ml | |||
| ERCP/ERPG | 240 mg iodine/ml | 20-50 ml | ||
| Herniography | 240 mg iodine/ml | 50 ml | The dose depends on the size of the hernia | |
| Hysterosalpingography | 240 mg iodine/ml or 300 mg iodine/ml | 15-50 ml 15-25 ml | ||
| Sialography | 240 mg iodine/ml or 300 mg iodine/ml | 0.5-2 ml 0.5-2 ml | ||
| Gastrointestinal tract examination | ||||
| Orally: | ||||
| Adults: | 350 mg iodine/ml | individually | ||
| Children: | ||||
| - esophagus | 300 mg iodine/ml or | 2 -4 ml/kg body weight | Maximum dosage 50 ml | |
| 350 mg iodine/ml | 2-4 ml/kg body weight | Maximum dosage 50 ml | ||
| Premature babies: | 350 mg iodine/ml | 2-4 ml/kg body weight | ||
| Rectally: | ||||
| Children: | Dilution with water to 100-150 mg iodine/ml | 5-10 ml/kg body weight | Example: dilute Omnipaque® 240 mg iodine/ml, 300 mg iodine/ml or 350 mg iodine/ml with water 1:1 or 1:2 | |
| CT scan | ||||
| Orally: | ||||
| Adults: | Dilute with water to ~6 mg iodine/ml | 800-2000 ml of diluted solution over one period of time | Example: dilute Omnipaque® 300 mg iodine/ml or 350 mg iodine/ml with water 1:50 | |
| Children: | Dilute with water to ~6 mg iodine/ml | 15-20 ml/kg body weight of diluted solution | ||
| Rectally: | ||||
| Children: | Dilute with water to ~6 mg iodine/ml | Individually | ||
Pharmacodynamics
Physicochemical characteristics:
Iohexol is a nonionic, monomeric, triiodinated, water-soluble radiocontrast agent. The pH of the drug is 6.8 - 7.6.
The osmolality and viscosity of Omnipaque® are given below:
| Concentration | Osmolality * (Osm/kg H2O) 37°C | Viscosity (mPa*s) | |
| 20°C | 37°С | ||
| 240 mg iodine/ml | 0,51 | 5,6 | 3,3 |
| 300 mg iodine/ml | 0,64 | 11,6 | 6,1 |
| 350 mg iodine/ml | 0,78 | 23,3 | 10,6 |
Iohexol is a non-ionic low-osmolar iodine-containing radiocontrast agent.
The time to achieve maximum radiopacity with conventional myelography is up to 30 minutes (after 1 hour it is no longer visualized). With computed tomography, visualization of contrast in the thoracic region is possible within 1 hour, in the cervical region - about 2 hours, in the basal cisterns - 3-4 hours. Contrast of the articular cavities, uterine cavity, fallopian tubes, peritoneal protrusions, pancreatic and bile ducts, and bladder is achieved immediately after administration.
Pharmacokinetics
Almost 100 percent of iohexol administered intravenously is excreted unchanged through normally functioning kidneys within 24 hours. The maximum concentration of iohexol in urine is determined approximately 1 hour after injection.
The half-life of the drug in patients with normal renal function is about 2 hours. No metabolites of the drug were detected. The binding of iohexol to plasma proteins is low (less than 2%) and has no clinical significance.
Indications for use Omnipak 350 mg iodine/ml 50 ml 10 pcs. injection
Omnipaque® is for diagnostic purposes only.
X-ray contrast agent for use in children and adults, intended for performing cardiac angiography, arteriography, urography, venography and contrast enhancement in computed tomography (CT); lumbar, thoracic and cervical myelography, CT cisternography after subarachnoid injection; arthrography, endoscopic retrograde pancreatography (ERPG), endoscopic retrograde cholangiopancreatography (ERCP), hysterosalpingography, herniography, sialography and gastrointestinal tract studies.
Contraindications
Hypersensitivity to the active ingredient or any excipient.
Severe thyrotoxicosis.
When using non-ionic radiocontrast agents, caution should be exercised:
- if you have a history of allergies, asthma or other adverse reactions to iodine-containing radiocontrast agents. Premedication with corticosteroids or antihistamines is recommended;
- when studying patients with severe cardiovascular diseases and pulmonary hypertension, due to the risk of developing hemodynamic disorders or arrhythmias;
- when studying patients with acute cerebral pathology, tumors or a history of epilepsy, due to the predisposition of this category of patients to seizures. The risk of developing seizures and neurological reactions is also increased in patients suffering from alcoholism or drug addiction;
- when studying patients with severe combined impairment of liver and kidney function, since their clearance of radiocontrast agents is significantly reduced;
- to prevent the development of acute renal failure after the introduction of radiocontrast agents, special attention should be paid to high-risk patients with impaired renal function and diabetes mellitus, as well as patients with paraproteinemia (myelomatosis and Waldenström's macroglobulinemia);
- when studying patients with hyperthyroidism. In patients with multinodular goiter, after administration of iodine-containing radiocontrast agents, there is a risk of developing hyperthyroidism. When administering radiocontrast agents to premature infants, the possibility of developing transient hyperthyroidism should be taken into account;
- when examining patients with hypovolemia, it is necessary to ensure adequate hydration, at least 100 ml every hour for 4 hours before the study and 24 hours after the study;
- When studying patients with multiple myeloma, diabetes mellitus, impaired renal function, newborns, children under one year old and elderly patients, adequate hydration is necessary before and after the administration of a radiocontrast agent.
For patients with diabetes mellitus taking metformin, before intravascular administration of iodinated radiocontrast agents, it is necessary to discontinue the drug for at least 48 hours before and for 48 hours after the procedure.
In emergency cases where renal function is unknown, the physician should assess the risk/benefit ratio of using a contrast agent: discontinue metformin, hydrate, monitor renal function, and monitor for early signs of lactic acidosis.
Application Omnipack 350 mg iodine/ml 50 ml 10 pcs. solution for injection during pregnancy and lactation
The drug should not be used in pregnant women, unless the expected benefit to the mother from its use outweighs the potential risk to the fetus, and such a study is prescribed by a doctor as necessary.
Contrast agents are excreted into breast milk to a small extent. Therefore, the likelihood of harm to the baby during breastfeeding seems unlikely. However, if it is necessary to administer the drug, breastfeeding should be stopped before administration of the drug and not resumed for at least 24 hours after the study.
Hysterosalpingography should not be performed in pregnant women or in the presence of acute pelvic peritonitis.
special instructions
Patient preparation and drug administration procedure
Before using contrast media, obtain accurate patient information, including laboratory data (including serum creatinine, electrocardiogram, history of allergies, and pregnancy). Before the study, the patient should eliminate fluid and electrolyte imbalances and ensure a sufficient supply of fluids and electrolytes.
This is especially true for patients with multiple myeloma, diabetes mellitus, polyuria or gout, as well as newborns, children under one year old and elderly patients.
The patient must stop eating 2 hours before the procedure.
It is not recommended to conduct preliminary testing of individual sensitivity using small doses of the drug, due to the risk of severe hypersensitivity reactions.
Patients who are afraid of waiting before the procedure require premedication with sedatives.
The risk of developing severe adverse reactions to Omnipaque® is small.
However, all iodinated contrast agents may cause anaphylactoid reactions or other manifestations of hypersensitivity. For this reason, it is necessary to foresee in advance the sequence of treatment measures in case of their occurrence and to have the necessary drugs and equipment available to provide immediate medical assistance.
It is recommended to always have a cannula or catheter in place to ensure rapid intravenous access throughout the radiographic procedure.
You should use a separate syringe and needle to administer Omnipaque® and do not mix it with other medications.
Compared to ionic drugs, non-ionic radiocontrast agents have less effect in vitro on the blood coagulation system. When performing angiographic studies, care should be taken to adhere to their technique and frequently flush the catheters (for example, with 0.9% sodium chloride solution with the addition of heparin) to minimize the risk of thrombosis and embolism associated with the intervention.
The administration of iodinated contrast agents may aggravate the symptoms of myasthenia gravis.
All iodine-containing contrast agents distort the results of radioisotope studies of the thyroid gland (the iodine-binding capacity of thyroid tissue remains reduced for 2 weeks after administration).
High concentrations of contrast media in plasma or urine may interfere with the results of biochemical tests to determine the concentration of bilirubin, proteins, or inorganic substances (eg, iron, copper, calcium, and phosphate). Therefore, such tests should not be performed on the day of the study.
For patients with diabetes mellitus taking metformin, before intravascular administration of iodinated radiocontrast agents, it is necessary to discontinue the drug for at least 48 hours before and for 48 hours after the procedure.
In emergency cases where renal function is unknown, the physician should assess the risk/benefit ratio of using a contrast agent: discontinue metformin, hydrate, monitor renal function, and monitor for early signs of lactic acidosis.
Measures to prevent adverse reactions:
Identification of patients at increased risk.
Ensure that the patient is adequately hydrated, if necessary, by continuous intravenous infusion, started before the drug is administered and continued until it is excreted by the kidneys.
Preventing additional stress on the kidneys resulting from the use of nephrotoxic drugs, oral drugs during cholecystography, renal artery clamping, renal artery angioplasty, or major surgery, until the contrast agent is removed from the body.
Repeated X-ray contrast studies should be performed no earlier than the moment when renal function is restored to its original level.
In patients with impaired renal and hepatic function, drug clearance may be significantly reduced.
Patients undergoing hemodialysis can be administered radiocontrast agents, provided that dialysis is carried out immediately after the examination.
Intrathecal administration:
After myelography, the patient should be in a horizontal position for 1 hour with his head and chest elevated by 20°. After which the patient can walk carefully, but should not bend over. If the patient remains in bed, then his head and chest should remain elevated for 6 hours. If a low seizure threshold is suspected, the patient should remain under medical supervision during this period of time. Outpatients should not be left unobserved for the first 24 hours after administration of a radiocontrast agent.
Impact on the ability to drive vehicles and operate machinery
It is not recommended to drive vehicles or operate any other machinery during the first 24 hours after intrathecal administration of contrast media.
Overdose
Overdose is unlikely in patients with normal renal function. When using high doses of the drug, the duration of the study has a major effect on the kidneys (the half-life of the drug is approximately 2 hours). There is no specific antidote, treatment is symptomatic, hemodialysis is possible.
Side effects Omnipaque 350 mg iodine/ml 50 ml 10 pcs. injection
General adverse reactions (for all indications for the use of iodine-containing radiocontrast agents).
The following are possible common side effects associated with the use of nonionic monomers. For side effects specific to a particular route of administration, see the relevant sections. Hypersensitivity reactions may occur regardless of dose or route of administration, and mild symptoms may be a precursor to a serious anaphylactoid reaction/shock. In this case, the administration of the radiocontrast agent should be stopped immediately and, if necessary, intravascular administration of specific therapeutic agents should be started.
After the administration of an iodine-containing radiocontrast agent, a slight transient increase in serum creatinine concentration is often observed, and contrast-induced nephropathy may develop.
Iodism or iodine mumps is a rare reaction to the administration of iodine-containing radiocontrast agents, expressed in enlargement and soreness of the salivary glands after a study lasting up to 10 days. The reported incidence of adverse reactions is based on primary clinical documentation and data from published studies involving more than 90,000 patients.
The frequency of adverse events is classified as follows: very often (≥1/10), often (≥1/100 to
Immune system disorders - Rare: hypersensitivity reactions (including shortness of breath, rash, erythema, urticaria, pruritus, skin reactions, vasculitis, angioedema, laryngeal edema, laryngospasm, bronchospasm or non-cardiogenic pulmonary edema). Reactions may occur immediately after the injection or several days later; Unknown: anaphylactic/anaphylactoid reaction, anaphylactic/anaphylactoid shock.
Nervous system disorders - Rarely: headache; Very rare: dysgeusia (transient sensation of a “metallic” taste in the mouth); Unknown: fainting.
Cardiovascular system disorders: Rare: bradycardia.
Vascular disorders - Very rare: increased blood pressure, decreased blood pressure.
Gastrointestinal disorders - Uncommon: nausea; Rarely: vomiting; Very rare: diarrhea, pain/discomfort in the abdominal area; Unknown: enlarged salivary glands.
General disorders and disorders at the injection site - Often: feeling of heat; Rarely: fever; Very rare: chills.
Injuries, intoxications and complications of manipulations - Unknown: iodism.
Intravascular administration (intraarterial and intravenous)
Please read the Common Adverse Reactions section first. Only those adverse reactions that occur with intravascular administration of nonionic monomeric radiocontrast agents are described below.
The nature of the adverse reactions that occur with intra-arterial administration depends on the injection site and the dose administered. Selective angiography and other procedures in which high concentrations of radiocontrast agent reach a specific organ may be accompanied by the development of complications in that organ.
Immune system disorders - Not known: severe skin reactions such as pustules or bullae.
Endocrine disorders - Unknown: thyrotoxicosis, transient hypothyroidism.
Mental disorders - Unknown: confusion.
Nervous system disorders - Rare: dizziness; Very rare: convulsions, impaired consciousness, encephalopathy, stupor, sensory disturbances (including hypesthesia), paresthesia, tremor; Not known: transient motor dysfunction (including speech impairment, aphasia, dysarthria), transient memory loss, confusion, coma and retrograde amnesia.
Visual impairment - Unknown: transient cortical blindness.
Hearing and balance disorders - Unknown: transient hearing loss.
Disorders of the cardiovascular system - Rarely: arrhythmia (including bradycardia, tachycardia); Very rare: myocardial infarction; Not known: severe complications (including cardiac arrest, cardiac arrest, respiratory arrest), coronary artery spasm, chest pain.
Vascular disorders - Very rare: hot flashes; Unknown: shock, arterial spasm, ischemia, thrombophlebitis and thrombosis.
Disorders of the respiratory system and mediastinum - Rarely: cough; Very rare: shortness of breath, non-cardiogenic pulmonary edema; Unknown: severe symptoms and signs of respiratory disorders, bronchospasm, laryngospasm, bronchial asthma attack.
Gastrointestinal disorders - Rarely: diarrhea; Unknown: exacerbation of pancreatitis, acute pancreatitis.
Skin and subcutaneous tissue disorders - Not known: bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash accompanied by eosinophilia and general symptoms, exacerbation of psoriasis.
Musculoskeletal and connective tissue disorders - Unknown: arthralgia.
Renal and urinary tract disorders - Rare: renal dysfunction, including acute renal failure.
General disorders and reactions at the injection site - Often: feeling of heat; Uncommon: pain and discomfort; Rarely: asthenic condition (for example, malaise, fatigue). Not known: injection site reactions (including extravasation), back pain.
Intrathecal administration
Please read the Common Adverse Reactions section first. Only those adverse reactions that occur with intrathecal administration of nonionic monomeric radiocontrast agents are described below.
When administered intrathecally, adverse reactions may occur several hours or even days after the diagnostic procedure. The incidence of adverse reactions is the same as after lumbar puncture. Headache, nausea, vomiting or dizziness may be largely due to a decrease in pressure in the subarachnoid space due to leakage of cerebrospinal fluid through the puncture hole. To minimize the decrease in pressure, avoid removing too much cerebrospinal fluid.
Mental disorders - Unknown: confusion.
Nervous system disorders - Very common: headache (may be severe and prolonged); Uncommon: aseptic meningitis (including chemical meningitis); Rarely: convulsions, dizziness; Not known: electroencephalogram abnormalities, meningismus, transient encephalopathy including temporary memory loss, coma, stupor and retrograde amnesia, motor dysfunction (including speech disorders, aphasia, dysarthria), paresthesia, hypoesthesia and sensory dysfunction.
Visual disorders - Unknown: transient cortical blindness, photophobia.
Hearing and balance disorders - Unknown: transient hearing loss.
Digestive system disorders - Common: nausea, vomiting.
Musculoskeletal and connective tissue disorders - Rare: neck pain, back pain; Unknown: muscle spasms; General disorders and reactions at the injection site; Rarely: pain in the limbs; Unknown: reactions at the injection site.
Intracavitary administration
Please read the Common Adverse Reactions section first. Only those undesirable reactions that occur with intracavitary administration of nonionic monomeric radiocontrast agents are described below.
Endoscopic retrograde cholangiopancreatography (ERCP)
Digestive system disorders - Often: pancreatitis, increased concentration of amylase in the blood.
Oral administration
Digestive system disorders - Very common: diarrhea; Often: nausea, vomiting; Uncommon: abdominal pain.
Hysterosalpingography (HSG)
Digestive system disorders - Very common: pain in the lower abdomen.
Arthrography
Musculoskeletal and connective tissue disorders - Unknown: arthritis.
General disorders and reactions at the injection site - Very common: pain.
Herniography
General disorders and reactions at the injection site - Unknown: pain after the procedure.
Description of some adverse reactions
Thromboembolic complications have been reported with contrast-enhanced cardiac angiography and angiography of the cerebral, renal and peripheral arteries. The administration of a radiocontrast agent may have contributed to the development of these complications.
Cases of cardiac complications, including acute myocardial infarction, have been described during or after contrast-enhanced coronary angiography. Patients who are elderly or have severe coronary artery disease, unstable angina, and left ventricular dysfunction are at increased risk of cardiac complications. In very rare cases, radiocontrast agents may cross the blood-brain barrier into the cerebral cortex, which may result in transient neurological reactions, including seizures, transient motor or sensory disturbances, confusion, memory loss and encephalopathy.
With an anaphylactoid reaction and shock, severe arterial hypotension and associated hypoxic encephalopathy, renal and liver failure may develop.
In some cases, local pain and swelling occur with extravasation of the radiocontrast agent, but these symptoms resolve without sequelae. Cases of inflammation, tissue necrosis and the occurrence of compartment syndrome have been described.
Use in pediatrics
Cases of transient hypothyroidism have been reported in children, including premature infants and newborns, after the administration of iodinated radiocontrast agents.
Premature babies are especially sensitive to the effects of iodine.
A case of transient hypothyroidism has been reported in a premature infant. The mother of this child was re-administered Omnipaque®. Adequate rehydration is necessary before and after the administration of radiocontrast media, this is especially important for young children. Nephrotoxic drugs should be discontinued. Reduced glomerular filtration, characteristic of young children, can also lead to delayed clearance of radiocontrast agents.
Drug interactions
When used simultaneously with antipsychotics, analgesics and antidepressants, Omnipaque® may lower the seizure threshold, increasing the risk of adverse reactions.
The use of Omnipaque® in patients with diabetic nephropathy taking biguanides (metformin) can lead to transient renal dysfunction and the development of lactic acidosis. As a precaution, it is necessary to stop taking biguanides 48 hours before the study and resume after complete stabilization of renal function.
Patients who took interleukin-2 less than 2 weeks before the study are prone to an increased incidence of delayed adverse reactions (flu-like conditions or skin reactions).
In patients taking beta-blockers, manifestations of anaphylaxis when using iohexol may be atypical and mistaken for vagal reactions.
Side effects of the drug Omnipaque
Side effects with the administration of non-ionic radiocontrast agents are usually moderate or mild, reversible and reported less frequently than with ionic contrast agents. Moderate general symptoms may occur, such as a feeling of warmth throughout the body or a transient metallic taste in the mouth. Feelings of discomfort and abdominal pain are very rare (≤1:1000), nausea and vomiting are also very rare (from 1:1000 to ≤1:100). Hypersensitivity reactions may occur, usually manifesting as mild respiratory and cutaneous reactions such as shortness of breath, rash, erythema, urticaria, pruritus and angioedema. They can develop either immediately after administration of the drug or several days later. Hypotension and fever may occur. There are reports of toxic skin reactions. Severe manifestations of hypersensitivity reactions, such as laryngeal edema, bronchospasm, pulmonary edema and anaphylactic shock, develop very rarely. Headache, nausea, vomiting or dizziness are possible with intrathecal administration and are associated with a decrease in pressure in the subarachnoid space due to the outflow of cerebrospinal fluid through the puncture site. Anaphylactoid reactions can occur regardless of the dose and route of administration. A severe reaction may begin with minor manifestations of hypersensitivity. In this case, it is necessary to immediately stop administering the drug and begin the necessary emergency therapy with intravascular administration of drugs. In patients taking β-adrenergic blockers, manifestations of anaphylaxis may be atypical and mistaken for vagal reactions. Vasovagal reactions in the form of arterial hypotension and bradycardia are observed very rarely. Severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) are very rare. Sometimes hyperthermia with the development of convulsions may occur. Iodism is an extremely rare reaction following the administration of iodinated contrast media. It can manifest itself as an increase in the size and pain of the salivary glands for up to 10 days after the study.
Special instructions for the use of the drug Omnipaque
Do not mix the drug in the same syringe with other diagnostic and medicinal products. Before using a radiocontrast agent, it is necessary to obtain accurate information about the patient, taking into account the results of laboratory and instrumental research methods (serum creatinine level, ECG, history of allergic reactions). Before the study, the patient's fluid and electrolyte balance must be restored. A history of allergies, asthma, and side effects to iodine-containing contrast agents requires increased attention. In these cases, it is necessary to consider the possibility of premedication with corticosteroids and antihistamines. The risk of severe side effects when using Omnipaque is low. However, iodinated contrast agents may cause anaphylactic reactions or other manifestations of hypersensitivity. For this reason, it is necessary to foresee the sequence of treatment measures in case of their occurrence and have the necessary drugs and equipment available. It is advisable to install an IV catheter during the X-ray contrast study in order to facilitate rapid IV administration of medications. Compared to ionic drugs, non-ionic radiocontrast agents have less effect in vitro on the blood coagulation system. When conducting angiographic studies, you should carefully adhere to their techniques and frequently flush the catheters to minimize the risk of thromboembolism caused by the intervention. Before and after administration of the contrast agent, it is necessary to ensure adequate hydration of the body. This is especially important in patients with multiple myeloma, diabetes mellitus, impaired renal function, as well as in children and the elderly. In children under one year of age, especially newborns, hemodynamic and electrolyte imbalances occur especially often. Caution should be exercised when studying patients with severe cardiovascular disease and pulmonary hypertension due to the risk of developing cardiac arrhythmias and hemodynamics. Patients with acute cerebral pathology, brain tumors and epilepsy are prone to developing seizures and require special attention. There is an increased risk of developing seizures and neurological reactions in drug addicts and alcoholics. There have been rare cases of temporary decrease in hearing acuity or deafness after myelography, which was probably associated with a drop in cerebrospinal fluid pressure after lumbar puncture. To prevent the development of acute renal failure associated with the administration of a contrast agent, special caution is required when studying patients who already have impaired renal function and diabetes mellitus. The same applies to the study of patients with paraproteinemias (myeloma, Waldenström's macroglobulinemia). Measures to prevent the development of side effects:
- identification of patients at risk;
- ensuring adequate hydration (if necessary, this can be achieved with a constant IV infusion, started before the contrast agent is administered and continued until it is completely eliminated by the kidneys);
- prevention of additional load on the kidneys that occurs when using nephrotoxic drugs, drugs for oral cholecystography, when clamping the renal arteries, angioplasty of the renal arteries, surgical interventions until the contrast agent is completely removed from the body;
- Repeated studies using radiocontrast agents should be performed after complete normalization of renal function after the last administration of the drug.
Particular caution should be observed when conducting studies in patients with severe combined impairment of renal and liver function, since they experience a significant decrease in the clearance of contrast agents. It is possible to perform studies using radiocontrast agents in patients undergoing hemodialysis, provided that dialysis is carried out immediately after the study. The administration of iodine-containing radiocontrast agents may increase the symptoms of myasthenia gravis. When performing invasive studies and interventions in patients with pheochromocytoma, prophylactic use of α-adrenergic receptor blockers is necessary to prevent hypertensive crises. Particular care is required when assessing patients with hyperthyroidism. In patients with multinodular goiter after administration of iodine-containing contrast agents, there is a risk of developing hyperthyroidism. One should remember about the possibility of developing transient hyperthyroidism in premature infants when contrast media are administered. After administration of the contrast agent, the patient should be observed for at least 30 minutes, since most adverse reactions occur during this period. However, longer-term side effects are also possible. Intrathecal administration After performing myelography, the patient should be at rest for at least 1 hour, lying down with his head and chest raised 20°. After this, the patient can be transferred to outpatient mode, but bending should be avoided. While maintaining bed rest, the elevated position of the head and chest should be maintained for the first 6 hours. If a low threshold for convulsive readiness is suspected, the patient must be observed during this period. Outpatients should not be left without observation during the first 24 hours after the study. The drug affects the speed and accuracy of reactions, therefore, during the first 24 hours after intrathecal administration of contrast media, you must refrain from driving.
Omnipaque, 350 mg iodine/ml, solution for injection, 200 ml, 10 pcs.
Diagnostic procedures using iohexol can only be carried out in a hospital setting with an intensive care unit and resuscitation unit by specially trained personnel with sufficient experience in performing this type of research (it is desirable to have an intravenous catheter during the X-ray contrast examination in order to facilitate rapid intravenous administration of the necessary medications). Measures should be taken to prevent adverse reactions: identification of patients at high risk; ensuring adequate hydration; preventing additional stress on the kidneys (use of nephrotoxic drugs or oral cholecystography agents, clamping or angioplasty of the renal arteries, surgery) until the contrast agent is removed from the body; Repeated radiopaque studies should not be performed until renal function returns to baseline. It is necessary to monitor the patient for at least 30 minutes after administration of the contrast agent. The study is carried out with special caution if there is a history of allergies, asthma, cardiovascular diseases, pulmonary hypertension, acute cerebral pathology, brain tumors, epilepsy, alcoholism, drug addiction, severe liver and kidney dysfunction, diabetes mellitus, hyperthyroidism, paraproteinemia. It should be borne in mind that the use of contrast agents in diabetics taking biguanides (metformin) can lead to transient impairment of renal function and the development of lactic acidosis (it is necessary to stop taking biguanides 48 hours before the study and resume after complete stabilization of renal function). Interleukin-2 taken by the patient less than 2 weeks before the study may increase the incidence of delayed adverse reactions (flu-like conditions or skin reactions). When performing X-ray contrast studies in patients undergoing hemodialysis, it is necessary to carry out dialysis immediately after the study. When performing invasive studies and interventions in patients with pheochromocytoma, prophylactic use of alpha-blockers is necessary to prevent hypertensive crises. In cases of inflammation or tissue necrosis during extravascular administration, cold and an elevated position of the limb are recommended; in cases of compression symptoms, surgical decompression is recommended. Prescribe with caution to the elderly and children due to the high risk of severe adverse reactions and the possibility of increased dehydration. When performing angiographic studies, careful technique should be followed and catheters should be flushed frequently (eg, with heparinized saline) to minimize the risk of procedure-related thrombosis and embolism. After myelography, the patient should be at rest for at least 1 hour, lying on his back with his head elevated. While maintaining bed rest, the elevated position of the head and chest should be maintained for the first 6 hours, and the patient must be monitored throughout the day. It is not recommended to drive a car or use any other machinery during the first 24 hours after intrathecal administration.
Interactions of the drug Omnipaque
The use of contrast media in diabetic patients taking biguanides (metformin) can lead to reversible renal impairment and lactic acidosis. To prevent them, it is necessary to stop taking biguanides 48 hours before the study and resume taking them after complete stabilization of renal function. Patients who took interleukin-2 less than 2 weeks before the study are prone to late adverse reactions (flu-like conditions or skin reactions). Omnipaque (for intrathecal administration) is incompatible with GCS. Phenothiazane derivatives and other antipsychotics, MAO inhibitors, tetracyclic antidepressants, central nervous system stimulants, analeptics reduce the epileptic threshold and increase the risk of developing convulsive seizures. β-adrenergic blockers and other antihypertensive drugs increase the likelihood of developing arterial hypotension.
Omnipaque, 10 pcs., 50 ml, 350 mgiodine/ml, solution for injection
Diagnostic procedures using iohexol can only be carried out in a hospital setting with an intensive care unit and resuscitation unit by specially trained personnel with sufficient experience in performing this type of research (it is desirable to have an intravenous catheter during the X-ray contrast examination in order to facilitate rapid intravenous administration of the necessary medications). Measures should be taken to prevent adverse reactions: identification of patients at high risk; ensuring adequate hydration; preventing additional stress on the kidneys (use of nephrotoxic drugs or oral cholecystography agents, clamping or angioplasty of the renal arteries, surgery) until the contrast agent is removed from the body; Repeated radiopaque studies should not be performed until renal function returns to baseline. It is necessary to monitor the patient for at least 30 minutes after administration of the contrast agent. The study is carried out with special caution if there is a history of allergies, asthma, cardiovascular diseases, pulmonary hypertension, acute cerebral pathology, brain tumors, epilepsy, alcoholism, drug addiction, severe liver and kidney dysfunction, diabetes mellitus, hyperthyroidism, paraproteinemia. It should be borne in mind that the use of contrast agents in diabetics taking biguanides (metformin) can lead to transient impairment of renal function and the development of lactic acidosis (it is necessary to stop taking biguanides 48 hours before the study and resume after complete stabilization of renal function). Interleukin-2 taken by the patient less than 2 weeks before the study may increase the incidence of delayed adverse reactions (flu-like conditions or skin reactions). When performing X-ray contrast studies in patients undergoing hemodialysis, it is necessary to carry out dialysis immediately after the study. When performing invasive studies and interventions in patients with pheochromocytoma, prophylactic use of alpha-blockers is necessary to prevent hypertensive crises. In cases of inflammation or tissue necrosis during extravascular administration, cold and an elevated position of the limb are recommended; in cases of compression symptoms, surgical decompression is recommended. Prescribe with caution to the elderly and children due to the high risk of severe adverse reactions and the possibility of increased dehydration. When performing angiographic studies, careful technique should be followed and catheters should be flushed frequently (eg, with heparinized saline) to minimize the risk of procedure-related thrombosis and embolism. After myelography, the patient should be at rest for at least 1 hour, lying on his back with his head elevated. While maintaining bed rest, the elevated position of the head and chest should be maintained for the first 6 hours, and the patient must be monitored throughout the day. It is not recommended to drive a car or use any other machinery during the first 24 hours after intrathecal administration.
Overdose of the drug Omnipaque, symptoms and treatment
The risk of overdose is minimal if more than 2000 mg/kg body weight of iodine is not administered to the patient within a short period of time. A prolonged procedure using the drug in high doses may affect renal function (half-life - 2 hours). Accidental overdose of the drug can occur during complex angiographic procedures in children, especially with repeated administration in high doses. Symptoms of overdose are cyanosis, bradycardia, acidosis, pulmonary hemorrhage, insomnia or drowsiness, weakness, fatigue, stupor, epileptic syndrome, coma, mental disturbances (hallucinations, depersonalization, disorientation, depression, amnesia), photophobia, meningism, hyperreflexia or areflexia , paralysis, tremor. In case of overdose, it is necessary to correct water-electrolyte imbalances. Renal function should be monitored over the next 3 days. If necessary, use hemodialysis to remove the drug. There is no specific antidote. For therapeutic purposes, diazepam is administered at a dose of 10 mg intravenously slowly, 20–30 minutes after the cessation of the seizure attack - phenobarbital at a dose of 200 mg intramuscularly. Monitor and support vital functions and provide symptomatic therapy.
