Urografin
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Urografin is an iodine-containing X-ray contrast agent for intracavitary and intravascular administration.
Release form and composition
The dosage form of the release of Urografin is a solution for injection 600 and 760 mg / ml (in 20 ml ampoules, 10 ampoules in a cardboard box or 10 pcs. In pallets, in a cardboard box 1 or 12 pallets).
Active substances in 1 ml of solution (60% or 76%):
- amidotrizoic acid - 471.78 or 597.3 mg (corresponds 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.
Indications for use
- urography (intravenous, retrograde);
- fistulography;
- arthrography;
- angiographic studies (all types);
- endoscopic retrograde cholangiopancreatography (ERCP);
- sialography;
- hysterosalpingography;
- intraoperative cholangiography.
Contraindications
Absolute:
- decompensated heart failure;
- severe hyperthyroidism;
- acute pancreatitis (during endoscopic retrograde cholangiopancreatography);
- pregnancy and inflammatory processes in the pelvic cavity in an acute course (during hysterosalpingography).
Relative (diseases / conditions in which the use of Urografin requires caution, especially when administered intravenously):
- heart failure;
- severe impairment of renal / hepatic function;
- severe general condition of the patient;
- emphysema of the lungs;
- decompensated diabetes mellitus;
- cerebral atherosclerosis;
- subclinical hyperthyroidism;
- spasms of cerebral vessels;
- generalized myeloma;
- nodular goiter;
- hypersensitivity to iodine-containing contrast media.
Due to the likelihood of neurotoxic phenomena, Urografin is not used in the following studies: myelography, ventriculography, cisternography.
Method of administration and dosage
Before performing abdominal angiography and urography, in order to facilitate diagnosis, it is recommended to thoroughly cleanse the patient's stomach. For 2 days before the examination, you should avoid food that can lead to flatulence (this primarily applies to salads, legumes, fruits, black and fresh bread, as well as any raw vegetables). On the eve of the examination, the last meal should be no later than 18 hours. It is also advisable to take a laxative in the evening. Long breaks in food intake, as well as the use of drugs with a laxative effect, are contraindicated for infants and young children.
To avoid the development of side effects or an increase in the reaction to the administration of the drug associated with anxiety, fear and pain, it is recommended to conduct a calm conversation with the patient or prescribe appropriate treatment.
With generalized myeloma, diabetes mellitus with nephropathy, polyuria, oliguria, hyperuricemia, as well as young children, infants and elderly patients, it is necessary to carry out adequate hydration. Violations of water and electrolyte balance should be eliminated before the study.
Urografin, ready for administration, is a clear, pale yellow or colorless solution. If the integrity of the ampoule is destroyed, the color changes or the appearance of visible particles, the drug cannot be used. The contrast agent must be drawn into the syringe immediately before the study.
The dose is determined by the age, weight, cardiac output, and general condition of the patient. In case of heart or kidney failure, it should be as low as possible. In patients belonging to this group, it is desirable to monitor the renal function for at least 3 days after the study.
To reduce the possible risk of thromboembolism, when performing angiography, it is necessary to frequently flush the used catheters with saline.
With intravascular injection, it is desirable that the patient lies. After the injection, you must carefully monitor the patient's condition for at least 30 minutes.
If several injections of Urografin in high doses are needed to clarify the diagnosis, then the interval between them should be 10-15 minutes. If more than 300-350 ml of solution is injected for adults once, an infusion of electrolyte solutions is necessary.
The solution heated to body temperature is injected and tolerated by patients more easily.
It is not recommended to evaluate sensitivity with a small test dose of Urografin, since this does not make it possible to predict the occurrence of a reaction. Moreover, the very definition of sensitivity in some cases leads to the development of serious and even fatal hypersensitivity reactions.
When performing intravenous urography, the rate of administration of Urografin is usually 20 ml / min. In case of heart failure, a dose of 100 ml or more is recommended to be administered for at least 20-30 minutes.
Recommended adult doses for injection of the drug: 76% solution - 20 ml, 60% - 50 ml. Increasing the dose of 76% solution to 50 ml significantly increases the diagnostic accuracy. If indicated, a further dose increase is possible.
Children with intravenous urography are usually prescribed a 76% solution as follows:
- under 1 year: 7-10 ml;
- 1-2 years: 10-12 ml;
- 2-6 years: 12-15 ml;
- 6-12 years old: 15-20 ml;
- over 12 years of age: adult dose.
Best of all, the renal parenchyma is displayed if the picture is taken immediately after the end of the administration of Urografin.
To visualize the urinary tract and renal pelvis in adults, the first image is taken 3-5 minutes, the second 10-12 minutes after the end of the drug administration, while young patients are advised to focus on the lower limit of the specified time range, the elderly - on the upper one.
For infants and young children, the first picture should be taken within 2 minutes after the administration of Urografin (due to poor contrast, late pictures may be required).
The time of infusion of 60% and 76% solution (100 ml) in adults and adolescents should be within 5-10 minutes, for patients with heart failure - from 20 to 30 minutes.
The first image should be taken immediately after the end of the infusion, the subsequent images should be taken within 20 minutes or later (in case of impaired excretion).
When performing aortography, coronary angiography or angiocardiography, in cases where a particularly high concentration of iodine is important, a 76% solution is usually used. The dose is determined by age, weight, minute volume of the heart, general condition of the patient, clinical problem, research methodology and volume of the investigated vascular area.
For retrograde urography, it is sufficient to use a 30% solution of Urografin (obtained by diluting a 60% solution with water for injection in a ratio of approximately 1: 1). It is recommended to warm the solution to body temperature before administration. If a higher contrast ratio is required, it is possible to use a 60% solution undiluted. When using it, irritation symptoms are usually observed in extremely rare cases.
When carrying out hysterosalpingography, arthrography, and especially ERCP, the process of administering Urografin must be monitored using fluoroscopy.
Side effects
The development of adverse reactions during the use of Urografin was assessed on the following scale:> 1% - often; 0, 1% - sometimes; <0.1% - rarely.
Intravascular use
In most cases, side effects are mild, transient, and moderate. However, there is also evidence of life-threatening and severe disabilities. The incidence of side effects when using ionic contrast agents is 12%, non-ionic - 3%.
The development of the following disorders was most often observed: vomiting, nausea, a 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, tremors, convulsions, photophobia, paresis / paralysis, coma, transient blindness, headaches, dizziness, impaired consciousness / agitation, amnesia, drowsiness; rarely - thromboembolic complications in a severe course, which can lead to a stroke;
- dermatological reactions: often - itching, rash, erythema, facial redness (associated with vasodilation); rarely - Lyell and Stevens-Johnson syndromes;
- allergic reactions: conjunctivitis, angioedema, pruritus, cough, urticaria, rhinitis (are moderately pronounced, can appear regardless of the method of administration and dose and are the first signs of an anaphylactic reaction); more severe reactions are possible, accompanied by the expansion of peripheral vessels and subsequent reflex tachycardia, arterial hypotension, loss of consciousness, agitation, respiratory disorders, cyanosis, impaired consciousness; rarely - laryngospasm, bronchospasm;
- local reactions: pain (in most cases with peripheral angiography), edema (with extravascular administration; as a rule, it goes away on its own without the appearance of subsequent complications); extremely rare - necrosis, tissue inflammation; sometimes - venous thrombosis and thrombophlebitis;
- others: headache, feeling of heat; sometimes - chills, malaise, fainting, increased sweating; rarely - swelling of the salivary glands, changes in body temperature.
Intracavitary introduction
Adverse reactions after the administration of Urografin in the body cavity develop rarely, most often several hours after the administration of the drug, which is associated with slow absorption from the area of administration and distribution in the body.
When ERCP is performed, as a rule, the level of amylase increases. Visualization of acini with ERCP may be accompanied by an increased likelihood of subsequent pancreatitis. There is information about rare cases of necrotizing pancreatitis.
Systemic allergic reactions are rare and mild. They usually manifest as skin reactions. However, it is impossible to completely exclude the possibility of developing severe hypersensitivity reactions.
special instructions
After the administration of Urografin, hypersensitivity reactions may develop, manifested as shortness of breath, erythema, urticaria, edema or itching of the face. Severe reactions are possible in the form of angioedema (including vocal cords), bronchospasm and anaphylactic shock. Typically, these reactions develop within 60 minutes after the introduction of the solution. In rare cases, delayed reactions may appear (after a few hours / days). An increased risk of severe reactions is observed in patients with a history of severe allergic reactions or reactions to iodine-containing contrast media.
If there are indications of a tendency to allergies, the use of antihistamines / glucocorticosteroids for prophylactic purposes should be considered.
Patients with bronchial asthma have an increased risk of developing hypersensitivity reactions or bronchospasm.
In cases of development of hypersensitivity reactions, the administration of Urografin is immediately canceled, if necessary, appropriate therapy is carried out.
The need to use the drug should be especially carefully evaluated in patients with poor general condition.
In rare cases, with intravascular administration, renal failure may occur. In order to prevent the development of acute renal failure, it is recommended to identify patients at risk. Main risk factors:
- gout;
- renal failure;
- a history of kidney disease;
- diabetes mellitus with nephropathy;
- information about the development of renal failure after the previous administration of a contrast agent;
- multiple myeloma;
- progressive vascular disease;
- paraproteinemia;
- severe chronic arterial hypertension;
- impending administration in high or repeated doses;
- age over 60 years.
Patients with an increased risk of developing renal failure should be adequately hydrated before administration of the drug.
Until complete elimination of Urografin, it is necessary to exclude additional burden on the kidneys, including the use of nephrotoxic and cholecystographic oral drugs, the imposition of an arterial clamp, major surgery and angioplasty of the renal arteries. It is recommended to postpone a new radiopaque study until renal function is fully restored.
Taking biguanides should be discontinued 48 hours before the study; therapy can be resumed no earlier than 48 hours after it (due to the high likelihood of lactic acidosis).
Intravascular administration of Urografin in heart failure can lead to pulmonary edema. Particular care should be taken with this method of administration of the drug in acute cerebral infarction, acute intracranial hemorrhage and other diseases, accompanied by a violation of the BBB integrity, 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.
In case of pheochromocytoma, preliminary administration of alpha-blockers is recommended (associated with the risk of developing a vascular crisis).
Against the background of autoimmune disorders, it is possible to develop severe vasculitis or a syndrome similar to Stevens-Johnson syndrome.
The introduction of Urografin can aggravate the symptoms of myasthenia gravis.
The BBB permeability can increase in acute / chronic alcoholism. This facilitates the penetration of Urografin into the brain tissue and can lead to reactions from the central nervous system. Because of the possible lowering of the seizure threshold, special care must be taken in patients with chronic alcoholism and drug users.
Before hysterosalpingography, possible pregnancy must be excluded.
After the introduction of Urografin for 24 hours, it is recommended to refuse to drive vehicles, which is associated with the likelihood of developing delayed hypersensitivity reactions.
Drug interactions
With the combined use of Urografin with certain drugs / substances, the following effects may develop:
- beta-blockers: hypersensitivity reactions are more pronounced;
- antipsychotics: the incidence of delayed adverse reactions (in the form of fever, urticaria, flu-like symptoms, joint pain, itching) increases.
Urografin for 2 weeks or more reduces the ability of thyroid tissue to accumulate radioisotopes during diagnostic studies of the thyroid gland.
Analogs
Urografin analogs are: Novatrizoat, Triombrast, Trazograf.
Terms and conditions of storage
Store in a place protected from X-rays and light at temperatures up to 30 ° C. Keep out of the reach of children.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
