Urografin solution for injection 760 mg/ml 20 ml ampoule N10
Preparing the patient for the procedure. The patient should be examined on an empty stomach, but water intake is not limited. Before the study, disturbances in water and electrolyte metabolism must be eliminated (especially in patients with an increased risk of complications).
When performing angiography of abdominal vessels and urography, to facilitate diagnosis, it is recommended to thoroughly clean the patient’s intestines. Therefore, in the last two days before the examination, you should avoid eating foods that cause flatulence (including legumes, salads, fruits, black and fresh bread, any raw vegetables). The last meal on the eve of the examination should be no later than 18:00. In addition, it is advisable to take a laxative in the evening. For infants and small children, large intervals in food intake, as well as the administration of laxatives, are contraindicated.
Before the study, the patient should be given a reassuring conversation or appropriate medications should be prescribed. Patients with multiple myeloma, uncompensated diabetes mellitus, poly- or oliguria, gout, infants and young children, and patients in serious condition should not limit fluid intake before using hypertensive radiocontrast agents.
For patients with pheochromocytoma, it is recommended to prescribe alpha-adrenergic receptor blockers (to avoid the risk of developing a hypertensive crisis).
General rules for the procedure. The contrast agent should be drawn into the syringe immediately before the start of the study. Remains of contrast agent unused during the study are not used further. When performing angiography, frequent flushing of the catheters used with saline is required to reduce the risk of thromboembolism. The contrast agent is better tolerated if it is warmed to body temperature.
Intravascular administration of a contrast agent is carried out with the patient in a supine position. After administration, the patient should be monitored for at least another 30 minutes, as Most severe complications occur during this period of time.
If several high single doses are required to clarify the diagnosis, then the interval between injections should be 10–15 minutes to compensate for the increased serum osmolarity due to the influx of interstitial fluid. If more than 300 ml of contrast agent is administered at a time, an intravenous infusion of electrolyte solutions is prescribed.
Intravenous urography
The injection rate is usually 20 ml/min. For patients with heart failure who are prescribed a dose of 100 ml or more, it is recommended that the administration time be increased to at least 10 minutes.
Dose for adults: 20 ml of 76% Urografin® solution or 50 ml of 60% Urografin® solution. Increasing the dose of 76% Urografin ® solution to 50 ml significantly increases the accuracy of diagnosis. Further increase in dose is possible if necessary for special indications.
Dose for children: due to the physiologically reduced concentration capacity of the still immature nephron of the kidneys, relatively high doses of Urografin® 76% are required. Children under 1 year - 7-10 ml, 1-2 years - 10-12 ml, 2-6 years - 12-15 ml, 6-12 years - 15-20 ml, over 12 years - doses for adults.
Time taken to take pictures. The renal parenchyma is best visualized if the image is taken immediately after the end of the contrast agent administration. To visualize the renal pelvis and urinary tract, the first image is taken 3-5 minutes, the second - 10-12 minutes after the administration of the contrast agent. In younger patients, images should be taken earlier (focus on the lower limit of the specified time), in older patients - later (focus on the upper limit of the specified time).
Retrograde urography
Usually, for this study, approximately 30% solution is sufficient, which can be obtained by diluting 60% Urografin® with water for injection in a 1:1 ratio. To avoid cold irritation causing ureteral spasms, it is recommended to warm the contrast agent to body temperature.
If it is necessary to conduct studies with an increased degree of contrast, you can also use an undiluted 60% solution of Urografin®. Despite its high concentration, signs of irritation are observed in rare cases.
Angiography
Urografin® can also be used for angiographic studies. The 76% solution is recommended for use in cases where a high iodine concentration is important (aortography, angiocardiography or coronary angiography). The dose depends on age, body weight, cardiac output, the general condition of the patient, the clinical problem being solved, the research technique, the type and volume of the vascular area being examined.
Release form and composition
The dosage form of Urografin is an injection solution of 600 and 760 mg/ml (in ampoules of 20 ml, in a cardboard pack of 10 ampoules or 10 pieces in pallets, in a cardboard pack of 1 or 12 pallets).
Active substances in 1 ml of solution (60% or 76%):
- amidotrizoic acid – 471.78 or 597.3 mg (corresponding to 292 or 370 mg of iodine);
- meglumine – 125.46 or 159.24 mg.
Additional components (600/760 mg/ml): sodium calcium edetate – 0.1/0.1 mg; sodium hydroxide – 5.03/6.29 mg; water for injection – 725.73/653.77 mg.
Drug interactions
When Urografin is used in combination with certain drugs/substances, the following effects may develop:
- beta-blockers: hypersensitivity reactions are more pronounced;
- neuroleptics: the incidence of delayed adverse reactions increases (in the form of fever, urticaria, flu-like symptoms, joint pain, itching).
Urografin for 2 weeks or more reduces the ability of thyroid tissue to accumulate radioisotopes during diagnostic studies of the thyroid gland.
Side effects
The development of adverse reactions during the use of Urografin was assessed on the following scale: > 1% - often; < 1% and > 0.1% – sometimes; <0.1% – rare.
Intravascular use
In most cases, side effects are mild, transient and moderate. However, there is also evidence of life-threatening and severe impairments. The incidence of side effects when using ionic contrast agents is 12%, non-ionic - 3%.
The most often observed development of the following disorders: vomiting, nausea, feeling of heat and pain.
Other possible side effects:
- cardiovascular system: sometimes - rhythm disturbances, clinically significant transient changes in heart rate and blood pressure; rarely - dangerous thromboembolic complications that can lead to myocardial infarction;
- respiratory system: often - shortness of breath, transient changes in respiratory rate, cough, respiratory failure; rarely – pulmonary edema, respiratory arrest;
- digestive system: often – vomiting, nausea; sometimes – abdominal pain;
- urinary system: rarely - impaired renal function up to renal failure;
- central nervous system (during cerebral angiography and other studies in which Urografin reaches the brain with arterial blood): sometimes - speech, hearing, vision disorders, tremor, convulsions, photophobia, paresis/paralysis, coma, transient blindness, headaches , dizziness, disturbance of consciousness/excitement, amnesia, drowsiness; rarely - severe thromboembolic complications, which can lead to stroke;
- dermatological reactions: often - itching, rash, erythema, redness of the face (associated with vasodilation); rarely - Lyell and Stevens-Johnson syndromes;
- allergic reactions: conjunctivitis, angioedema, itching, cough, urticaria, rhinitis (are moderate in nature, can appear regardless of the method of administration and dose and are the first signs of the development of an anaphylactic reaction); more severe reactions are possible, accompanied by dilatation of peripheral vessels and subsequent reflex tachycardia, arterial hypotension, loss of consciousness, agitation, breathing problems, cyanosis, disturbances of consciousness; rarely – laryngospasm, bronchospasm;
- local reactions: pain (in most cases with peripheral angiography), swelling (with extravascular administration; as a rule, it goes away on its own without subsequent complications); extremely rarely – necrosis, tissue inflammation; sometimes – vein thrombosis and thrombophlebitis;
- others: headache, feeling hot; sometimes - chills, malaise, fainting, increased sweating; rarely - swelling of the salivary glands, change in body temperature.
Intracavitary administration
Adverse reactions after the introduction of Urografin into the body cavity rarely develop, most often a few hours after administration of the drug, which is associated with slow absorption from the injection site and distribution in the body.
During ERCP, amylase levels usually increase. Visualization of acini with ERCP may be accompanied by an increased likelihood of subsequent pancreatitis. There are reports of rare cases of necrotizing pancreatitis.
Systemic allergic reactions develop rarely and are mild in nature. As a rule, they manifest themselves as skin reactions. However, the possibility of developing severe hypersensitivity reactions cannot be completely excluded.
Contraindications
Absolute:
- decompensated heart failure;
- severe hyperthyroidism;
- acute pancreatitis (during endoscopic retrograde cholangiopancreatography);
- pregnancy and acute inflammatory processes in the pelvic cavity (during hysterosalpingography).
Relative (diseases/conditions in which the use of Urografin requires caution, especially with intravenous administration):
- heart failure;
- severe impairment of renal/hepatic function;
- severe general condition of the patient;
- emphysema;
- decompensated diabetes mellitus;
- cerebral atherosclerosis;
- subclinical hyperthyroidism;
- spasms of cerebral vessels;
- generalized myeloma;
- nodular goiter;
- hypersensitivity to iodine-containing contrast agents.
Due to the likelihood of neurotoxic phenomena, Urografin is not used during the following studies: myelography, ventriculography, cisternography.
special instructions
After administration of Urografin, hypersensitivity reactions may develop, manifested as difficulty breathing, erythema, urticaria, swelling or itching of the face. Severe reactions are possible in the form of angioedema (including vocal cords), bronchospasm and anaphylactic shock. As a rule, these reactions develop within 60 minutes after administration of the solution. In rare cases, delayed reactions may occur (after several hours/days). An increased risk of severe reactions is observed in patients with a history of severe allergic reactions or reactions to iodinated contrast agents.
If there are indications of a tendency to allergies, the use of antihistamines/glucocorticosteroids for prophylactic purposes should be considered.
There is an increased risk of developing hypersensitivity reactions or bronchospasm in patients with bronchial asthma.
In cases of hypersensitivity reactions, the administration of Urografin is immediately canceled and, if necessary, appropriate therapy is carried out.
The need for the drug should be especially carefully assessed in patients with poor general condition.
In rare cases, intravascular administration may cause renal failure. In order to prevent the development of acute renal failure, it is recommended to identify patients at risk. Main risk factors:
- gout;
- renal failure;
- history of kidney disease;
- diabetes mellitus occurring with nephropathy;
- information about the development of renal failure after the previous administration of a contrast agent;
- multiple myeloma;
- progressive vascular diseases;
- paraproteinemia;
- severe chronic arterial hypertension;
- upcoming administration of high or repeated doses;
- age over 60 years.
Patients with an increased risk of developing renal failure should receive adequate hydration before administration of the drug.
Until complete elimination of Urografin, it is necessary to exclude additional stress on the kidneys, including the use of nephrotoxic and cholecystographic oral drugs, arterial clamping, major surgery and angioplasty of the renal arteries. It is recommended to postpone a new X-ray contrast study until renal function is fully restored.
Taking biguanides should be stopped 48 hours before the test; therapy can be resumed no earlier than 48 hours after the test (due to the high likelihood of developing lactic acidosis).
Intravascular administration of Urografin in heart failure can lead to pulmonary edema. Particular caution with this method of drug administration should be observed in case of acute cerebral infarction, acute intracranial hemorrhage and other diseases accompanied by disruption of the integrity of the BBB, acute demyelination or cerebral edema. The likelihood of neurological complications is higher in patients with a recent history of stroke, cerebrovascular disease, or frequent transient ischemic attacks.
For pheochromocytoma, preliminary administration of alpha-blockers is recommended (associated with the risk of developing a vascular crisis).
Against the background of autoimmune disorders, severe vasculitis or a syndrome similar to Stevens-Johnson syndrome may develop.
Administration of Urografin may increase the symptoms of myasthenia gravis.
BBB permeability may increase in acute/chronic alcoholism. This facilitates the penetration of Urografin into brain tissue and can lead to reactions from the central nervous system. Due to the possible decrease in the seizure threshold, special caution should be observed in patients with chronic alcoholism and patients taking drugs.
Before performing hysterosalpingography, possible pregnancy must be excluded.
After administration of Urografin, it is recommended to refrain from driving vehicles for 24 hours, which is associated with the likelihood of developing delayed hypersensitivity reactions.
