Uurografine

Injection solution Uroganin belongs to the category of iodine-containing radiocontrast preparations.

Indications of the urographina

Injection solution Urografine is used for intravenous and retrograde urography.

Urografine can be used for any angiographic diagnostic procedures, for arthrographic and cholangiographic studies. The drug is actively used for ERCP (cholangiopancreatography), as well as for sialografic and fistulographic procedures, or for hysterosalpingography.

Release form

The injectable aqueous solution of Urografine has the form of a transparent liquid without a certain color shade.

Active ingredient Uroganin is amidotrizoic acid and meglumine.

The preparation is packed into glass transparent or orange ampoules of 20 ml each. Ten ampoules are in a dense container, placed in a pack of cardboard.

Another type of packing of Urografin is also possible - 120 ampoules per box of cardboard packed in dense container packs of ten pieces each.

Pharmacodynamics

Urografine improves the contrast of the image: iodine, present in amidotrizoate, absorbs X-rays.

The pharmacological properties of Urographin can be described as follows:

• Urographin 60%:
  • iodine concentration of 292 mg per ml;
  • osmolarity 1.5 osmol / kg H ₂ O;
  • the viscosity level is 7.2 and 4 mPa / s at 20 ° and 37 ° C, respectively;
  • the density level is 1.33 and 1.323 g per ml at 20 ° and 37 ° C, respectively;
  • the pH is from 6.0 to 7.0.
• Urographine 76%:
  • iodine concentration 370 mg per ml;
  • osmolarity 2.1 osmol / kg H ₂ O;
  • the viscosity level is 18.5 and 8.9 mPa / s at 20 ° and 37 ° C respectively;
  • a density level of 1.418 and 1.411 g per ml at 20 ° and 37 ° C, respectively;
  • the pH is from 6.0 to 7.0.

It has been experimentally confirmed that Urografine does not have mutagenic, teratogenic, embryotoxic and genotoxic properties. Also, the oncogenic effect of the drug was not detected.

Pharmacokinetics

After intravenous administration of Urographin, its binding to plasma proteins can reach no more than 10%.

After 5 minutes after intravenous bolus infusion of 60% solution in an amount of 1 ml / kg of weight, the concentration of Urografine in serum is determined, in accordance with the amount of iodine 2-3 g / l. For three hours after the infusion of Urografines, a relatively rapid drop in concentration is found: the half-life is 1-2 hours.

The active ingredient does not enter the erythrocytes. With intravascular infusion well spreads through the intercellular substance. Do not pass through the whole blood-brain membrane, in small quantities found in breast milk.

The diagnostic amount of the drug passes glomerular renal filtration. Approximately 15% of Urografine is excreted unchanged with the urinary fluid within half an hour after infusion. More than half of the total amount of the drug leaves the body for three hours.

The distribution and excretion of Urografins is independent of the amount of the drug administered. Increasing or increasing the dosage leads to an increase or decrease in the level of contrast in the bloodstream. But, given the increase in osmotic diuresis with increasing dosage, the concentration content of contrast in the urinary fluid does not increase equally.

Use of the urographina during pregnancy

Studies that were conducted using the active ingredients of Urografine did not confirm the probability of teratogenic and embryotoxic effects of the injection solution. However, at the present time, there is insufficient clinical experience with the use of Urographin in women during pregnancy and lactation.

Given the undesirability of using the X-ray method of research in pregnancy in general, it is not necessary to assert the possibility of using the contrast method.

In the lactation period, Urographin in contrast radiography is used only for strict indications.

Contraindications

Urografine can not be used in patients with significant hyperthyroidism, as well as with heart failure in the stage of decompensation.

Urografine is not suitable for myelographic, ventriculographic and cisternographic procedures, due to the danger of neurotoxic effects.

Hysterosalpingography is not prescribed for pregnant women and patients with acute forms of inflammatory reactions in the pelvic region.

Cholangiopancreatography is not performed during the exacerbation of pancreatitis.

Relative contraindications to Urografins are:

• hypersensitivity to iodine preparations;
• severe liver damage or renal filtration;
• insufficiency of cardiovascular activity;
• emphysema of the lungs;
• cerebral arteriosclerosis;
• diabetes mellitus in the stage of decompensation;
• hyperthyroidism, nodes in the thyroid gland;
• spasms of cerebral vessels.

Side effects of the urographina

With intravascular administration of Urographin, adverse events are mostly mild and pass on their own. However, there are descriptions of a number of cases with a severe course of adverse symptoms.

The most frequent manifestations are dyspeptic phenomena, abdominal pains and a feeling of heat in the body.

• Allergic manifestations can be expressed as angioedema, inflammation of the conjunctiva of the eye, coughing, rashes on the skin, rhinitis. Such signs are not in all cases dose-dependent. If the first symptoms of anaphylactoid reaction are found, then it is urgent to cancel the introduction of Urographin and begin the specific treatment.

In severe cases, the infusion of Urografen may be accompanied by an expansion of peripheral vessels, a violation of cardiac activity, respiratory depression, a state of arousal, a consciousness disorder.

Rarely were the phenomena of broncho- and laryngospasm, lowering of blood pressure.

Among the common reactions, most often a feeling of heat and pain in the head. Less common is fever, fainting.

On the part of the respiratory system there are coughing, difficulty breathing, less often - pulmonary edema.

Possible development of tachycardia or bradycardia, fluctuations in blood pressure, arrhythmia. Thromboembolism and myocardial infarction are extremely rare.

Typical seizures of nausea with vomiting.

When performing angiography of cerebral vessels, neurological signs may appear in the form of dizziness, headache, changes in consciousness, speech disorders, visual dysfunction, seizures, tremors in limbs, drowsiness.

Stroke is considered an extremely rare complication.

A circadian injection of Urografine can cause local pain, swelling of the tissues, without the development of thrombosis and phlebitis.

• With intracavitary administration of Urografine, side effects are rare. ERCP may show an elevated level of amylase. Rarely there is development of pancreatitis.

[1]

Dosing and administration

If the patient has a procedure for urography or angiography of the abdominal region, then a gastric cleansing should be performed. Two days before the diagnosis, it is necessary to exclude foods that provoke bloating (peas, fresh fruits, raw vegetables, bread). The last time before the examination, food can be taken no later than 18 hours. In the evening on the eve of the procedure, it is advisable to use a laxative drug.

If necessary, the doctor may prescribe sedatives.

The doctor dials Urografine into the syringe immediately before the diagnosis. Quality Urographin is usually transparent or has a faint yellowish hue. If the solution has a different color, a precipitate, or if the integrity of the ampoule has been compromised, the drug is not used.

If residual solutions remain after the procedure, then they must be disposed of. You can not use the remaining remedy.

The amount of Urograins administered is determined individually. If the patient suffers from kidney or cardiovascular disease, the amount of the drug should be minimized whenever possible.

During angiography, catheters are washed as often as possible to avoid the formation of blood clots. If Urografine is injected into the vessels, then it is preferable if the patient is at this time to stay in a horizontal position. After administration of the solution for half an hour, the patient's condition should be carefully monitored by the doctor.

If you require a single injection of more than 300 ml of Urografine, an additional infusion of electrolytes should be prescribed.

The most comfortable infusion of Urografine is expected after heating the solution to a temperature of 37 ° C. At that, only the volume of the preparation that is expected to be heated is heated.

Preliminary it is recommended to test Urografine, to determine the hypersensitivity of the organism to a contrast agent.

Intravenous urography is performed at an infusion rate of 20 ml per minute. If the patient suffers from heart failure, the duration of the infusion should be at least 20-30 minutes.

Typically, an adult patient is administered 20 ml of 76% of Urografin, or 50 ml of 60% of Urografine. At individual indications, the dosage is increased.

In childhood, 76% solution is used:

• from 0 to 1 year - up to 10 ml;
• from 1 to 2 years - from 10 to 12 ml;
• from 2 to 6 years - from 12 to 15 ml;
• from six to 12 years - from 15 to 20 ml;
• For children over 12 years old, adult doses are used.

Infusion administration of Urografine should be carried out with a duration of at least five minutes and no longer than 10 minutes. Patients with insufficient cardiac activity, the duration of the infusion is extended to half an hour.

[2], [3]

Overdose

With the accidental introduction of a large amount of Urografine solution, it can be removed from the body by extracorporeal dialysis.

Interactions with other drugs

With the simultaneous administration of Urografine and β-blockers, hypersensitivity can increase.

The development of long-term side effects is more likely in individuals who simultaneously receive interleukin.

[4], [5], [6], [7]

Storage conditions

Urografine is stored under standard temperature conditions, which do not exceed + 30 ° C. The drug must be protected from bright sunlight, from exposure to X-rays, from free access of children.

[8], [9], [10]

Shelf life

Urografins can be stored for up to 5 years in packaged form.

[11]