Composition, form of production and packaging
Tablets are white or grayish white, round, flat, chamfered, with a risk on one side and engraved "UREGYT" on the other side, practically odorless.
ethacrynic acid 50 mg
Excipients: gelatin - 6.8 mg, lactose monohydrate - 75 mg, magnesium stearate - 4 mg, potato starch - 58.2 mg, talc - 6 mg.
10 pieces. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Etakrinaic acid is a fast-acting diuretic that functions at the level of the ascending section of the Henle loop, the proximal and distal renal tubules. Ectric acid suppresses the active transport of chloride ions and, consequently, sodium. The development of the effect occurs rapidly and independently of the acid-base balance.
Etakrinovaya acid promotes increased excretion of potassium, so the therapy with this diuretic should be accompanied by appropriate correction of the potassium content in the blood plasma.
The diuretic effect depends on the dose and is related to the degree of fluid retention. When ethacrynic acid is used, water and electrolytes are eliminated from the body several times more intensively than with thiazide diuretics, because ethacrynic acid significantly suppresses sodium reabsorption. That is why ethacrynic acid is effective in severe renal failure. The drug has almost no effect on glomerular filtration and renal blood flow, except in cases when there is a pronounced decrease in plasma volume associated with an increase in diuresis. Excretion of electrolytes against the background of therapy with ethacrynic acid occurs differently than with the use of thiazide diuretics. The primary elimination of sodium and chloride ions is accompanied by a significant loss of chloride ions in comparison with sodium ions.
When the drug is taken for a long time, the excretion of chloride ions decreases, whereas the excretion of potassium and hydrogen ions can be enhanced. Ectric acid is effective in both acidosis and alkalosis.
After ingestion, ethacrynic acid is rapidly and completely absorbed from the digestive tract. Bioavailability is 100%. The diuretic effect begins 30 minutes after taking the drug, the maximum diuretic effect is achieved. After 2 hours, and the effect persists for 6 to 8 hours.
Communication with plasma proteins is 90%.
Metabolism is carried out in the liver by conjugation.
The drug is mainly excreted by the kidneys (60%), and 40% is excreted through the intestine, partly (20%) unchanged, partly in the form of conjugates.
Etacrynic acid does not penetrate the blood-brain barrier. Poorly excreted in hemodialysis.
- swelling of the cardial, renal, post-thrombotic type, swelling in the background of portal hypertension;
- with ineffectiveness of therapy with other diuretic drugs.
The initial, daily dose of the drug is 50 mg (1 tablet). In the future, the dose can be gradually increased until the desired effect is achieved, but not more than 200 mg (4 tablets). The drug is effective from 8 to 10 hours, so it is recommended to take the entire daily dose in the morning after breakfast.
For a gradual diuretic effect, a minimal dose of the drug (25 mg) is sufficient.
In adult patients, the desired diuretic effect can be achieved by using a dose of 50-100 mg. During therapy it is necessary to regularly monitor diuresis.
The usual maintenance dose is 25 to 200 mg per day.
Supportive therapy can be carried out with the skipping of individual doses to maintain the effectiveness of the drug. The drug can be given in a day or two days, or at intervals of 2-3 days.
Older patients sometimes require lower doses.
Combination therapy: ethacrynic acid can be used effectively in combination with other diuretics.
Undesirable effects are presented according to the following frequency grouping criteria: frequent (> 1/100 to <1/10), infrequent (from> 1/1000 to <1/100), rare (from> 1/10000 to <1 / 1000), very rare (<1/10000) adverse reactions, with an unidentified prevalence (prevalence can not be determined based on available clinical data).
On the part of the hematopoiesis and lymphatic system: agranulocytosis and severe neutropenia were observed in several patients in critical condition, with which the drug was prescribed to provide a diuretic effect. Rarely: development of thrombocytopenia.
From the side of the central nervous system: often: headache, fatigue; rarely: anxiety, impaired consciousness.
On the part of the organs of sight and hearing: blurred vision, reversible deafness, ringing in the ears, dizziness with a feeling of stuffiness in the ears. Deafness can also be irreversible, especially in patients receiving concomitant therapy with other ototoxic drugs.
From the gastrointestinal tract: often: discomfort and abdominal pain, dysphagia, nausea, vomiting and diarrhea; very rarely: profuse diarrhea, gastrointestinal bleeding; acute pancreatitis. In rare cases, jaundice and increased activity of "hepatic" enzymes in the serum, the blood of patients who simultaneously received several drugs, including ethacrylic acid.
From the urinary system: hematuria.
From the skin: rarely: Shenlaine-Henoch disease, rash.
From the metabolism: anorexia, hyperuricemia, gout attack, hypoglycemia, hyperglycemia.
Laboratory indicators: decrease in the level. blood glucose, nitrogen-kropi, uric acid, potassium, calcium, chlorides, magnesium and sodium.
Other: fever, chills.
- pronounced violations of water-electrolyte balance and acid-base state;
- hepatic coma;
- pregnancy and the period of breastfeeding;
- deficiency of lactase and glucose-galactose malabsorption
(tablets contain, lactose, monohydrate);
- Children under 18 years of age (lack of sufficient clinical data);
- hypersensitivity to the active or any other component of the drug.
With caution: elderly age, cirrhosis with and without ascites, hypokalemia, hypomagnesemia, water-electrolyte balance disorders, primary hyperaldosteronism, connective tissue diseases (systemic lupus erythematosus).
PREGNANCY AND LACTATION
Controlled trials of the drug during pregnancy were not conducted. Taking the drug Uregit is contraindicated in pregnant women, since like other diuretics, can cause hypovolemia with increasing blood viscosity, which reduces the blood flow of the placenta.
It is currently unknown whether ethacrynic acid is capable of penetrating into breast milk, so if taking this medication is necessary, the patient should stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in anuria.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution in cirrhosis. Contraindicated in hepatic coma.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years.
APPLICATION IN ELDERLY PATIENTS
With caution in old age.
Treatment should begin with low doses, which should be increased gradually to avoid dehydration. Follow the patient's body weight.
During the period of treatment, it is necessary to regularly monitor the electrolyte content in the blood plasma, use the food rich in potassium, if necessary, prescribe potassium preparations.
Uregit can be used in combination with other diuretics, the effect of which is summarized.
No additional administration of potassium is required, many patients receiving diuretics. However, the administration of potassium chloride is recommended, or the use of potassium-sparing diuretics in patients with cirrhosis, nephrotic syndrome, or those receiving digitalis preparations. Patients with normal renal function can be prescribed potassium preparations (with a regular control of the level of potassium in the blood plasma), tk. excess of potassium is excreted from the body. With renal failure, you can not administer potassium. Indications for the introduction of potassium are always set depending on the potassium content in the blood plasma.
If the patient develops diarrhea with large losses of fluid, then therapy should be discontinued. During therapy it is recommended to carry out a systematic control of the electrolyte content in the blood plasma. Ectric acid may potentiate concomitant antihypertensive therapy. There is a risk of development about pro static collapse.
With excessive diuresis, the drug should be discontinued until the water-electrolyte state stabilizes. With large losses of electrolytes, you can reduce the dose of the drug or temporarily discontinue therapy.
Patients with cirrhosis of the liver should be given the drug with great care, tk. Diuretic drugs increase the risk of hepatic coma, which can lead to death.
At a high risk of metabolic alkalosis (cirrhosis with ascites), the use of potassium-sparing diuretics or the introduction of potassium chloride can weaken or prevent hypokalemia.
Loop diuretics reduce the level of magnesium ions in the blood.
Excessive fluid loss in the urine (rapid and pronounced weight loss) can lead to severe hypotension. In elderly patients with cardiac pathology, excessive diuresis may be accompanied by a decrease in the volume of circulating plasma and an increased risk of thromboembolic complications. Care should be taken when prescribing the drug to patients prone to hypokalemia (some cases of diarrhea, chronic heart failure, taking digitalis drugs, ventricular arrhythmias in history, kidney disease with potassium loss, hyperaldostrenia with normal renal function, systemic lupus erythematosus in history).
Effects of cardiac glycosides can be enhanced against a background of hypokalemia caused by diuretics.
With concomitant therapy, hormonal drugs that induce potassium loss (corticosteroids) require laboratory monitoring.
With renal edema, the effectiveness of this diuretic can be reduced by hypoproteinemia.
The risk of orthostatic hypotension may increase with concomitant use of alcohol, barbiturates and diazepam.
During therapy with ethacrine acid, do not consume alcoholic beverages. Athletes should be aware that against the background of therapy with ethacrynic acid false positive results of doping control can be obtained.
In view of the lack of sufficient clinical data, Uregit is not recommended for children.
Each tablet of Uregit contains 75 mg of lactose, therefore, this drug should not be taken by patients with rare hereditary intolerance to galactose, insufficiency of lactase and malabsorption syndrome of glucose and galactose.
Impact on the ability to drive vehicles and manage mechanisms
In the initial individually defined period of treatment, it is necessary to refrain from potentially dangerous activities requiring a rapid mental and motor reaction. In the process of further treatment, the degree of restriction is determined depending on the individual tolerability of the drug.
Symptoms: lower blood pressure, excessive diuresis, loss of electrolytes and dehydration.
Treatment: symptomatic and supportive. Vomit or rinse the stomach. If necessary, eliminate dehydration, electrolyte disorders and hepatic coma. If breathing is disturbed, inhalation of oxygen should be performed and artificial ventilation should be established.
The active substance is poorly removed from the bloodstream by hemodialysis. There is no specific antidote.
Hypotensive drugs and ethanol (possibly strengthening the hypotensive and / or diuretic effect). In the initial period of therapy with angiotensin converting enzyme (ACE) inhibitors, a diuretic should be discontinued or the dose of an ACE inhibitor should be reduced to avoid severe arterial hypotension.
Hypoglycemic agents for oral administration - there may be a decrease in their effectiveness.
Anticoagulants (warfarin, coumarin): ethacrynic acid displaces them from complexes with plasma proteins, which can enhance the anticoagulant effect. You should choose a dose of anticoagulant or go to furosemide.
Ectric acid can enhance the ototoxicity of aminoglycosides and csphalosporins. The simultaneous use of these drugs should be avoided.
Nonsteroidal anti-inflammatory drugs can weaken the diuretic or antihypertensive effect.
Lithium (elevated levels of lithium can cause symptoms of intoxication).
Corticosteroids: may increase the risk of hypokalemia and bleeding from the gastrointestinal tract.
TERMS OF RELEASE FROM PHARMACY
TERMS AND CONDITIONS OF STORAGE
Store at a temperature of 15 to 25 В° C. Keep out of the reach of children. Shelf life - 5 years.