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

Active substanceIodixanolIodixanol

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Visipac®

solution for injections

JI Halskea Limited United Kingdom

Iodixanol

solution for injections

JODAS EKSPOIM, LLC Russia

Dosage form: & nbspinjection

Composition:

1 ml of solution for injection contains:

Active substance:	150 mg iodine / ml	270 mg iodine / ml	320 mg iodine / ml
Iodixanol	306 mg (equivalent to 150 mg of iodine)	550 mg (equivalent to 270 mg iodine)	652 mg (equivalent to 320 mg of iodine)
	306 mg (equivalent to 150 mg of iodine)	550 mg (equivalent to 270 mg iodine)	652 mg (equivalent to 320 mg of iodine)
Excipients:
Trometamol	1.20 mg	1.20 mg	1.20 mg
Sodium chloride	4.03 mg	1.87 mg	1.11 mg
Calcium chloride dihydrate	0.09 mg	0.07 mg	0.04 mg
Sodium calcium edetate (in terms of anhydrous base)	0.10 mg	0.10 mg	0.10 mg
1M sodium hydroxide solution or 1M hydrochloric acid solution	to pH 6.8-7.7	to pH 6.8-7.7	to pH 6.8-7.7
Water for injections	up to 1 ml	up to 1 ml	up to 1 ml

Description:A clear, colorless or pale yellow solution.

Pharmacotherapeutic group:radiopaque

ATX: & nbsp

V.08.A Radiocontrast iodine-containing substances

Pharmacodynamics:

Iodixanol is a nonionic iodine-containing radiopaque preparation. After injection, organically bound iodine concentrates in the vessels and some tissues (kidneys, thyroid gland and others), cerebrospinal fluid, making them radiopaque.

The use of iodixanol in diabetic patients with serum creatinine levels of 1.3-3.5 mg / dL was accompanied by an increase in creatinine by 0.5 mg / dL, but no patient experienced an increase of more than 1.0 mg / dl.The secretion of enzymes (alkaline phosphatase and N-acetyl-β-glucosaminidase) in the proximal tubules of the kidneys was weaker than after the administration of nonionic monomeric radiopaque agents and the same as after administration of ionic dimeric radiopaque agents.

Pharmacokinetics:

Iodixanol is rapidly distributed in the extracellular fluid of the body. The distribution period averages about 21 minutes. The apparent volume of distribution, equal to the volume of extracellular fluid (0.26 l / kg body weight), indicates the distribution of the drug only in the extracellular fluid. Metabolites of iodixanol were not detected. The protein binds less than 2% of the drug.

Half-life (T_1/2) is about 2 hours In infants, the withdrawal of the drug is slower - about 4 hours. Iodixanol mainly excreted by the kidneys through glomerular filtration. After intravenous administration of iodixanol to healthy volunteers, approximately 80% of the administered dose is withdrawn in urine within 4 hours in unchanged form and 97% of the drug within 24 hours. The maximum concentration of the drug in the urine is reached about 1 hour after the injection.In the range of recommended doses, pharmacokinetics does not have a dose-response relationship. After intrathecal administration of T1/2 iodixanol increases and is about 12 hours.

Indications:

Radiopaque means for cardioangiography, coronary angiography, cerebral angiography, peripheral angiography, abdominal aortography, digital subtractional arteriography (DSA), urography, phlebography, contrast enhancement in computed tomography (CT) and gastrointestinal tract (GI) examination; lumbar, thoracic and cervical myelography; arthrography, hysterosalpingography (GHA).

In children for cardioangiography, urography, contrast enhancement in CT and GIT.

Contraindications:

Hypersensitivity to iodixanol or other components of the drug, data on serious adverse reactions to iodixanol in the anamnesis, manifesting thyrotoxicosis.

Carefully:

Patients with severe cardiovascular diseases, pulmonary hypertension, acute cerebral pathology, tumors or epilepsy in an anamnesis, who suffer from alcohol or drug dependence, hyperthyroidism,severe impairment of liver and kidney function.

Pregnancy and lactation:

Data on the use of iodixanol during pregnancy are absent. Therefore, the drug should be used during pregnancy only in cases where the potential benefit to the mother justifies the potential risk to the fetus.

Until now, the possibility of getting iodixanol into the milk of a nursing woman has not been studied. After the introduction of the drug, breast-feeding should be stopped and its renewal is possible not earlier than 24 hours after the administration.

Hysterosalpingography should not be performed in pregnant women and in the presence of acute pelvic peritonitis.

Dosing and Administration:

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

Iodixanol should be taken into the syringe immediately before use. Unused remnants of the drug for further use are not allowed.

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

Preparation of the patient. Before using radiopaque, you need to obtain accurate information about the patient, including laboratory data (including serum creatinine, ECG, allergy, pregnancy).

2 hours before the procedure should refrain from eating. When the drug is administered, the patient should be in a horizontal position.

Preliminary testing of individual sensitivity using small doses of the drug is not recommended in connection with the risk of developing severe hypersensitivity reactions, as when using other iodine-containing radiopaque agents.

Patients who are afraid of the procedure, it is desirable to introduce sedatives.

Procedure of drug administration. Before the introduction Iodixanol it is necessary to heat up to body temperature (37 ° C), like other radiopaque preparations.

Nonionic radiocontrast agents in comparison with ionic agents have less effect on the blood coagulation system in vitro. When performing vascular catheterization, you should pay careful attention to the technique of angiography and often flush the catheter (for example, 0.9% solution of sodium chloride with the addition of heparin) to minimize the risk of thrombosis and embolism.

During the administration of the drug, the patient should be in a horizontal position.

Recommended dosing regimen. Dosage depends on the type and method of study, age, body weight, hemodynamic status, the general condition of the patient. Usually the same concentration and volume are used as with other iodine-containing radiopaque agents. In some studies, sufficient diagnostic information was obtained using iodixanol with a slightly lower concentration of iodine.

The recommended dosage regimen is shown in the table below.

Doses for intra-arterial administration are indicated for a single injection, which can be repeated.

Indication / Examination	Concentration		Scope
Intraarterial (in/a) introduction
Arteriography
Selective cerebral	150/270/320⁽¹⁾ mg iodine / ml		5-10 ml / injection
Aortography	270/320 mg iodine / ml		40-60 ml / injection
Peripheral	150/270/320 mg iodine / ml		30-60 ml / injection
Selective visceral in /a DSA	270 mg iodine / ml		10-40 ml / injection
Cardioangiography
Adults
Left ventricle and aorta root	320 mg iodine / ml		30-60 ml / injection
Selective coronary angiography	320 mg iodine / ml		4-8 ml / injection
Children	270/320 mg iodine / ml		Depending on age, body weight and pathology (max, total volume not more than 10 ml / kg)
Intravenous (iv) administration
Urography
Adults	270/320 mg iodine / ml		40-80 ml⁽²⁾
Children (body weight <7 kg)	270/320 mg iodine / ml		2-4 ml / kg
Children (body weight> 7 kg)	270/320 mg iodine / ml		2-3 ml / kg All doses, depending on age, body weight and pathology (max 50 ml)
Phlebography	270 mg iodine / ml		50-150 ml / limb
Gain at CT
CT of head (adults)	270/320 mg iodine / ml		50-150 ml
CT of the body (adults)	270/320 mg iodine / ml		75-150 ml
CT of head and body (children)	270/320 mg iodine / ml		2-3 ml / kg up to 50 ml All doses, depending on age, body weight and pathology (in some cases, up to 150 ml per child can be administered)
Intrathecal administration
Lumbar and thoracic	270 mg iodine / ml or		10-12 ml ⁽³⁾
myelography (lumbar injection)	320 mg iodine / ml		10 ml⁽³⁾
Cervical myelography	270 mg iodine / ml or		10-12 ml ⁽³⁾
(cervical or lumbar injection)	320 mg iodine / ml		10 ml⁽³⁾
Introduction to the body cavity
Arthrography	270 mg iodine / ml		1-15 ml
GHA	270 mg iodine / ml		5-10 ml (the recommended dose can be exceeded several times, for example, with back flowing into the vagina (doses up to 40 ml were used)
Gastrointestinal	Dose is selected individually for optimal visualization
Oral:
Adults
Evaluation of the passage of the gastrointestinal tract	320 mg iodine / ml		Doses of 80-200 ml were used
Esophagus	320 mg iodine / ml		Doses of 10-200 ml were used
Stomach	320 mg iodine / ml		Doses of 20-200 ml were used
Children	270/320 mg iodine / ml		5 ml / kg body weight, doses of 10-240 ml
Rectal:
Children		270/320 mg iodine / ml	Doses of 30-400 ml were used

(1) All concentrations can be used, but in most cases 270 mg / iodine ml is recommended;

(2) In some cases, a dose of 80 mg may be exceeded;

(3) To reduce possible adverse reactions, the total dose should not exceed 3.2 g of iodine.

Side effects:

Allergic reactions: breathing disorders (dyspnea, bronchospasm), skin reactions (rash, erythema, urticaria, pruritus), including severe bullous or pustular reactions, angioedema, fever, laryngeal edema, pulmonary edema and anaphylactoid reactions (anaphylactic shock).

Local reactions: discomfort at the injection site.

From the nervous system: headache, convulsions, transient disorders of motor or sensory function. Iodixanol can penetrate the blood-brain barrier, as a result of which the accumulation of the drug in the cerebral cortex can be visualized with CT. This phenomenon can persist for 1-2 days and is accompanied by a transient disruption of orientation in space or cortical blindness.

From the urinary system: in patients at high risk, acute renal failure is possible.

From the digestive system: a feeling of discomfort or pain in the abdomen, nausea, vomiting.

From the sense organs: a violation of taste, visual impairment.

From the side of the cardiovascular system: vasovagal reactions in the form of arterial hypotension and bradycardia are observed. When injected into the coronary, cerebral or renal arteries, an arterial spasm can develop, leading to transient ischemia of the corresponding organs. It is possible to increase blood pressure, severe cardiovascular disorders in the form of rhythm disturbances, reducing myocardial contractility or myocardial ischemia. Postphlebographic thrombophlebitis or thrombosis may occur.

From the side of the musculoskeletal system: arthralgia.

Laboratory indicators: a transient increase in creatinine in the blood, but it usually has no clinical significance.

Other: slightly expressed feelings of warmth or cold snap in the whole body, complaints of pain in the distal parts of the limbs.Parotitis (iodine pig) is possible for iodixanol administration, expressed in the increase and soreness of the salivary glands with a duration of up to 10 days after administration.

Intrathecal application:

After myelography, unwanted reactions can be distant, occur after several hours or even days after the procedure.

Local reactions: In the area of injection, there may be local soreness and radicular pain.

From the nervous system: headache or dizziness is more associated with a decrease in pressure in the subarachnoid space as a result of leakage of cerebrospinal fluid at the site of the puncture. Some patients may experience severe headache within a few days. To prevent a decrease in intracranial pressure, excessive selection of cerebrospinal fluid should be avoided.

Previously, with the use of other nonionic radiocontrast agents based on iodine, symptoms of meningeal irritation, photophobia, the possibility of developing infectious meningitis, temporary disruption of cerebral function, manifested convulsions, temporary confusion, temporary impairment of motor or sensory function, changes in EEG were observed.

From the digestive system: nausea, vomiting - are also associated with a decrease in pressure in the subarachnoid space.

Measures for the prevention of adverse reactions:

- identification of patients at high risk;

- ensuring adequate rehydration. If necessary, it can be achieved via a constant on / in infusion started until the radiopaque drug administration and continuing up to its excretion by the kidneys;

- preventing the additional load on the kidneys arising from the use of nephrotoxic drugs, drugs for oral cholecystography, cross-clamping of the renal artery, renal artery angioplasty, surgical operations - before removing the radiopaque drug from the body;

- repeated fluoroscopic studies should be carried out not earlier than the moment when the renal function is restored to the original level.

Overdose:

Overdose is unlikely iodixanol in patients with normal renal function. In the case of using high doses of great importance in regard to the effect on the kidney is the duration of the procedure (half-life of the drug is approximately 2 hours).

Treatment - symptomatic. In case of an accidental overdose, the loss of water and electrolytes should be replenished with the help of infusion therapy.

Kidney function should be monitored for at least 3 days. If necessary, it is possible to use hemodialysis to remove iodixanol from the patient's body. There is no specific antidote.

Interaction:

When applied simultaneously with antipsychotic drugs, analgesics and antidepressants iodixanol can reduce the convulsive threshold, increasing the risk of adverse reactions.

The use of iodixanol in patients with nephropathy who take biguanides (metformin) can lead to a transient disruption of kidney function and the development of lactic acidosis. As a precaution, it is necessary to stop taking biguanides 48 hours before the test and resume after complete stabilization of kidney function.

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-blockers,manifestations of anaphylaxis when iodixanol is used can be atypical and mistaken for vagal reactions.

Special instructions:

Hypersensitivity

The risk of serious allergic reactions when using iodixanol is low. Nevertheless, the development of anaphylactoid or other allergic reactions is possible, which requires the availability of appropriate medications and equipment for resuscitation.

It is desirable to use a permanent cannula or catheter for quick access to the vessel during the entire study.

Premedication with glucocorticosteroids or antihistamine drugs is recommended.

In the study of patients with multiple myeloma, diabetes mellitus, impaired renal function, newborns, children under one year, and elderly patients, adequate hydration is necessary before and after the administration of the radiopaque. Babies and especially newborns are sensitive to disturbance of water-electrolyte balance and changes in hemodynamics.

When the liver and kidney function is significantly impaired, the clearance of the drug is significantly reduced. Patients on hemodialysis can receive Iodixanol for radiological procedures provided that dialysis will be performed immediately after the study.

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

In the study of patients with pheochromocytoma, prophylaxis should be given to alpha-adrenoblockers to prevent hypertensive crisis.

In the study of patients with hypovolemia, adequate hydration of at least 100 ml every hour for 4 hours before the study and 24 hours after the test should be ensured.

Patients with diabetes mellitus metformin, before intravascular administration of iodine-containing radiocontrast agents, the drug should be discontinued for at least 48 hours before and within 48 hours after the procedure.

In emergency cases, when renal function is not known, the doctor should evaluate the risk / benefit ratio of using radiopaque: stop the use of metformin, carry out water stress, monitor kidney function, monitor the appearance of the initial signs of lactic acidosis.

Distorts the results of radioisotope studies of the thyroid gland (iodo-binding ability of thyroid tissue remains reduced within 2 weeks after drug administration).

High concentrations of the drug in the patient's plasma can affect the results of laboratory studies to determine the concentration of bilirubin, proteins, iron, calcium, copper and phosphate. Therefore, such tests should not be performed on the day of the study.

Particular care should be taken in patients with hyperthyroidism. Patients with multinodular goiter have an increased risk of developing hyperthyroidism after the introduction of iodine-containing radiocontrast agents. In preterm infants after the administration of the drug, there is the possibility of developing transient hyperthyroidism.

To prevent the development of acute renal failure after the introduction of radiopaque means, special attention should be paid to patients with paraproteinaemia (myelomatosis and Waldenstrom macroglobulinemia).

Intrathecal administration

After myelography, the patient should be in a horizontal position for 1 hour with a raised head and chest raised to 20 °. After that, the patient can walk gently, but should not bend over. If the patient remains in bed, then within 6 hours his head and chest should remain elevated.If you suspect a low convulsive threshold, the patient should remain under medical supervision during this period of time. Outpatient patients can not be left unattended in the first 24 hours after the administration of radiopaque.

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 introduction of radiopaque means.

Form release / dosage:

Solution for injection, 150 mg iodine / ml, 270 mg iodine / ml, 320 mg iodine / ml.

Packaging:

For 20, 50 or 100 ml of the preparation of all dosages in a colorless glass bottle (USP, type I), closed with a stopper of chlorobutyl rubber and crimped with an aluminum cap, top covered with a snap-off plastic lid. A bottle with a volume of 50 and 100 ml contains a label, the lower part of which is used to suspend the bottle.

50, 100, 200 and 500 ml of the preparation of all dosages into a bottle of polypropylene sealed with a plug of chlorobutyl rubber and closed with a screwed polypropylene cover, provided with a ring for monitoring the first opening and a ring for tearing off the sealing gasket from above.The vial has a label, the lower part of which is used to suspend the vial.

For 1 or 10 glass or polypropylene vials of the preparation together with the instruction for use are placed in a cardboard box.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002413

Date of registration:02.04.2014

Date of cancellation:2019-04-02

The owner of the registration certificate:JODAS EKSPOIM, LLC JODAS EKSPOIM, LLC Russia

Manufacturer: & nbsp

NOVALEK PHARMACEITICAL, Pvt. Ltd. India

Representation: & nbspJodas Expoim, Open CompanyJodas Expoim, Open Company

Information update date: & nbsp11.11.2015

Illustrated instructions

Instructions

Iodixanol (ODIXANOL)