Vizipac

Visipaque is a radiocontrast drug containing iodine (non-ionic type).

When administered intravenously, organically synthesized iodine passes into the vessels and individual tissues (thyroid glands, kidneys, etc.), as well as the cerebrospinal fluid, forming their radiocontrast. After the procedure, this iodine absorbs radiation. [ 1 ]

Testing with volunteers did not show any significant deviations in most hemodynamic parameters, coagulation values, and clinical and biochemical characteristics after administration of the drug. [ 2 ]

Indications Vizipac

It is used in cardiac angiography, cerebral angiography, DSA procedure, peripheral arteriography, venography, peritoneal angiography, urography, and also for contrast potentiation during CT X-ray examination. [ 3 ]

Release form

The drug is released in the form of a liquid, inside the bottles: iodine 0.27 g / ml - in 0.05 or 0.1 l. There are 10 such bottles in a pack. Iodine 0.32 g / ml - in bottles of 0.02, 0.05, 0.1, 0.2 or 0.5 l. Inside the box - 10 bottles.

Pharmacokinetics

After intravascular administration, iodixanol is distributed at high speed into the extracellular fluid. The average distribution term is approximately 21 minutes.

Synthesis with protein is less than 2%. The half-life is approximately 2 hours. Metabolic elements of the drug have not been detected. Iodixanol excretion is mainly realized through the kidneys by CF.

With intravenous injection in volunteers, about 80% of the dose enters the urine after 4 hours, and after 24 hours - 97% of the drug. Only 1.2% of the dosage is excreted with feces in 72 hours. The Cmax level in urine is determined after approximately 1 hour from the moment of injection.

Dosing and administration

General information regarding the use of the medicine.

The medication is administered intravenously or intraacularly. Like other substances intended for parenteral procedures, Visipaque should be visually examined before use to identify the possible presence of insoluble elements, damage to the integrity of the bottle, and changes in the shade of the medicinal liquid.

The substance is drawn into the syringe immediately before the test procedure. The vials can only be used once; any leftovers that were not used during the procedure must be disposed of.

It is forbidden to mix the medicine with other substances. Separate needles and syringes are used for different products.

The process of preparing a patient to receive an injection.

Before the introduction of a contrast agent, it is necessary to obtain accurate information about the patient, including laboratory test results (for example, serum creatinine levels, history of allergies, ECG values, and pregnancy).

Before the procedure, it is necessary to eliminate the disorders of the EBV indicators and provide the patient with the required supply of water and salt elements. This is especially important for people with polyuria, multiple myeloma or gout, as well as for diabetics, infants, newborns, babies and the elderly.

The last meal should be taken no later than 120 minutes before the injection.

During the procedure, the patient must remain in a lying position. For half an hour after the completion of the study, the patient's condition must be monitored by a physician - because most of the negative signs develop during this period. It is prohibited to perform preliminary tests of personal tolerance with the introduction of small doses of the drug, because this can provoke severe symptoms of hypersensitivity.

People who experience fear while awaiting the procedure are given premedication using sedatives.

The contrast fluid must be warmed to body temperature before use.

During angiographic procedures, it is necessary to adhere very carefully to their methodology and regularly flush the catheters used (for example, with heparinized physiological fluid) to reduce the likelihood of embolism and thrombosis.

Dosages may vary depending on the type of procedure, weight, age, hemodynamic parameters, as well as the general condition of the patient and the testing technique used. Iodine concentrations and injection volumes used for other modern radiocontrast agents containing iodine are often used.

The following doses can be used (dosages intended for intravenous injections are single doses, but can be reused if necessary):

Intra-arterial procedures.

Arteriography:

• selective cerebral: 0.27/0.32 g/ml iodine – injection of 5-10 ml;
• selective cerebral DSA procedure (i/a): 0.15 g/ml iodine – injection of a 5-10 ml portion;
• aortography: 0.27/0.32 g/ml iodine – injection 40-60 ml;
• peripheral: 0.27/0.32 g/ml iodine – injection 30-60 ml;
• peripheral DSA (i/a): 0.15 g/ml iodine – injection 30-60 ml;
• selective visceral DSA (intra-arterial): 0.27 g/ml iodine – injection 10-40 ml.

Cardiac angiography for adults:

• aortic root with left ventricle: 0.32 g/ml iodine – injection 30-60 ml;
• selective coronary angiography: 0.27 g/ml iodine – injection 4-8 ml.

Intravenous studies:

• urography: 0.27/0.32 g/ml iodine – injection 40-80 ml (2);
• venography: 0.27 g/ml iodine – injection of 50-80 ml into the limb area.

Potentiation during CT:

• CT procedure in the brain area: 0.27/0.32 g/ml iodine – 50-150 ml;
• CT scan of the body area: 0.27/0.32 g/ml iodine – 75-150 ml.

Application for children

The medication is used in pediatrics for urography, cardioangiography, examinations of the digestive system and for contrast enhancement during CT procedures.

Use Vizipac during pregnancy

Visipaque should not be used during pregnancy, unless the potential benefit outweighs the risk of adverse effects and there is a clear need to order such a test.

Contrast agents are poorly excreted in breast milk and are poorly absorbed in the intestine. Because of this, the possibility of adverse effects on the baby is quite low. However, it is still recommended to stop breastfeeding for 24 hours if the drug is required.

Contraindications

Main contraindications:

• severe intolerance associated with radiocontrast drugs containing iodine;
• presence in the anamnesis of information regarding strong adverse effects associated with the drug;
• CHF (stages 2-3), CRF, liver failure, dehydration, active phases of renal/hepatic dysfunction and severe hyperthyroidism;
• epilepsy;
• multiple myeloma;
• hysterosalpingography is prohibited during active phases of inflammation affecting the pelvic area;
• ERCP procedure is not performed in people with active pancreatitis;
• The medication cannot be used intrathecally.

Side effects Vizipac

Side effects that occur with intravascular injection:

• damage to the blood and lymph system: thrombocytopenia may develop;
• immune disorders: sometimes intolerance symptoms appear. Development of anaphylactoid shock or anaphylactoid manifestations is possible;
• mental disorders: anxiety or agitation may occur sporadically. Confusion may occur;
• problems with the nervous system function: headaches sometimes occur. Dizziness is occasionally observed. Amnesia, stroke, fainting, paresthesia and sensory disorders (including taste changes) occur sporadically. Convulsions, tremors, motor dysfunction, comatose state, disorders of consciousness or temporary contrast-induced encephalopathy (including hallucinations) may develop;
• visual impairment: visual disturbances or temporary cortical blindness appear sporadically;
• Disorders in the functioning of the cardiovascular system: arrhythmia (including tachycardia with bradycardia) or myocardial infarction are occasionally observed. Cardiac arrest occurs sporadically. Spasms or thrombosis in the coronary arteries, heart failure, angina pectoris, cardiac conduction disorders, ventricular hypokinesia and respiratory arrest with the heart may occur;
• vascular system disorders: hot flashes sometimes occur. Blood pressure values occasionally decrease. Ischemia or blood pressure increases occasionally. Arterial spasm, shock, thrombophlebitis or thrombosis may develop;
• lesions of the mediastinum, sternum and respiratory organs: cough is occasionally observed. Dyspnea occurs occasionally. Respiratory arrest, development of respiratory failure or pulmonary edema are possible;
• digestive dysfunction: sometimes vomiting or nausea occurs. Occasionally – discomfort or pain in the abdominal area. An active phase of pancreatitis or its exacerbation may be observed, as well as an increase in the size of the salivary glands;
• subcutaneous and epidermal lesions: sometimes urticaria, rashes and itching occur. Isolated cases - erythema or Quincke's edema. TEN, erythema multiforme, drug rashes accompanied by eosinophilia and general manifestations, SJS, bullous or allergic dermatitis, epidermal peeling, toxicoderma or exanthematous pustulosis (generalized form in the active phase) may develop;
• Disorders associated with the musculoskeletal system and connective tissues: muscle spasms and back pain occur sporadically. Arthralgia may develop;
• disorders in the functioning of the urinary tract and kidneys: renal dysfunctions are observed sporadically, including acute renal failure;
• systemic lesions and changes at the injection site: sometimes there is pain in the sternum area and a feeling of heat. Rarely - chills, discomfort and pain, hyperthermia and signs in the injection area, including extravasation. Asthenia (severe fatigue and malaise) or a feeling of cold are observed isolated;
• intoxications, injuries and complications caused by the study: iodism may develop.

Adverse symptoms that occur with intrathecal use.

Side effects are delayed and may develop several hours or days after intrathecal injection. The frequency of occurrence is approximately the same as the frequency of development of disorders during lumbar punctures without the use of a contrast agent. The introduction of other non-ionic contrast elements may lead to the appearance of symptoms of irritation of the brain membrane (meningism, photophobia or chemical meningitis). In addition, the risk of developing meningitis of infectious genesis must be taken into account. Among other disorders:

• immune disorders: signs of intolerance may appear, including anaphylactoid/anaphylactic symptoms;
• disorders of the nervous system function: headaches sometimes occur (can be long-lasting and intense). It is also possible to develop temporary contrast-induced encephalopathy (among the manifestations are amnesia, hallucinations, confusion and other neurological signs) or dizziness;
• problems with digestive activity: sometimes vomiting develops. Nausea may occur;
• disorders associated with the functioning of connective tissues and the musculoskeletal system: muscle spasms may occur;
• systemic signs and changes in the injection area: the development of tremors or the appearance of pain in the area of drug administration is possible.

Adverse effects caused by the HSG (hysterosalpingography) procedure:

• immune manifestations: development of signs of hypersensitivity is possible;
• problems with the functioning of the nervous system: headaches are often observed;
• digestive dysfunction: pains mainly appear in the abdominal area. Nausea is often noted. Vomiting may develop;
• Reproductive disorders: mainly vaginal bleeding is observed;
• Systemic manifestations and changes at the injection site: hyperthermia is often observed. Symptoms at the injection site or tremors may occur.

Negative symptoms caused by arthrography:

• immune disorders: symptoms of intolerance may occur, including anaphylactic or anaphylactoid symptoms;
• systemic disorders, as well as changes in the injection area: pain in the injection area often develops. Tremors may occur.

Adverse reactions that occur with intracavitary use of drugs:

• immune disorders: intolerance effects may occur, including anaphylactoid or anaphylactic reactions;
• problems with digestive function: nausea, diarrhea and pain in the abdominal area are often observed. Vomiting sometimes occurs;
• systemic signs and changes at the injection site: tremors may develop.

Overdose

In people with healthy renal function, the risk of poisoning with Visipaque is very small. When administering large doses of the drug, the duration of the procedure is of great importance in relation to its effect on the kidneys (the half-life of the drug is approximately 2 hours).

In the event of accidental poisoning, the loss of water-salt levels is replenished through infusion.

It is necessary to monitor the patient's kidney function for at least 3 days after the end of the study. If it is necessary to remove iodixanol from the body, hemodialysis can be performed. The drug has no antidote.

Interactions with other drugs

Use in combination with painkillers, antipsychotics and antidepressants may lead to a decrease in the seizure threshold, increasing the likelihood of negative symptoms.

Administration of the drug to people with diabetic nephropathy who use biguanides (for example, metformin) may provoke temporary renal dysfunction and the development of lactic acidosis. To prevent such disorders, it is necessary to stop using biguanides 2 days before testing and resume it only after renal function has completely normalized.

Individuals who used IL-2 less than 14 days before the study procedure are prone to an increased incidence of adverse events (epidermal symptoms or flu-like conditions).

In people using beta-blockers, signs of anaphylaxis may be atypical and may therefore be mistaken for vagal manifestations.

Storage conditions

Visipack should be stored in a dark place, out of reach of children. Do not freeze the liquid. Temperature values are within 30°C.

Shelf life

Visipaque can be used within a maximum period of 36 months from the date of manufacture of the pharmaceutical substance.

Analogues

Analogues of the drug are the medications Tomogexol, Iomeron, Pamirei with Omnipaque, Unipak and Scanlux with Optiray, as well as Ultravist.