Uralit-u granules for oral solution 280g

Dosage form

Granulate for the preparation of oral solution

Composition

In a measuring spoon (2.5 g) of granules for preparing a solution for oral administration contains: potassium-sodium-hydrogen citrate 2.4277 g.
Excipients: hydrated water of the active substance 67.3 mg, dye sun-sunset (E 110) 0.2 mg, lemon oil 4.8 mg.

Packaging

In a polypropylene container 280 g. In a plastic bag a measuring spoon made of polystyrene, a clamp, indicator paper, a control calendar. In a cardboard box 1 container, 1 p / e package.

Mechanism of action

Uralit-U alkalizes urine, dissolves and prevents the formation of uric acid stones. For a long time, it keeps the reaction bias to the alkaline side, at which uric acid salts are in solution and do not form calculi. The process is dose-dependent. Alkalosis reduces urinary Calcium excretion. Presumably, citrate ions are an effective physiological inhibitor of calcium oxalate (and calcium phosphate) crystallization and aggregation of these crystals.

Indications and usage

- To dissolve uric acid stones.
- To prevent (prevention of recurrence) the formation of calcium-containing and uric acid stones, as well as mixed stones - calcium oxalate / uric acid or calcium oxalate / calcium phosphate.

Contraindications

- Hypersensitivity to the drug.
- Acute or chronic renal failure.
- Metabolic alkalosis.
- Hereditary episodic adynamia.
- Chronic urinary tract infections caused by urea-splitting bacteria (risk of struvite stones).
- A diet low in salt.
- Acute dehydration.
- Patients who combine urine pH above 7 with poorly controlled diabetes mellitus or adrenal insufficiency.
- Use in children under 12 years old is not recommended, as there is not enough clinical experience relative to this age group.
Uralit-U is used with caution in patients with severely impaired liver function.

Clinical data on the use of Uralit-U in pregnant women is not enough. Experimental studies on animals did not reveal any signs of teratogenic or embryotoxic action of the drug. Since the active ingredient is a combination of substances present in the body in the norm, the drug can be used during pregnancy and lactation according to the indicated recommendations for dosing. If necessary, use during pregnancy and lactation should relate the expected benefits to the mother and the likely risk to the fetus and baby.

Dosage and administration

Pellets should be dissolved in a glass of water and drink.
To dissolve and prevent the recurrence of the formation of uric acid stones: As a rule, take 4 scoops (= 10 g of granules, equivalent to 88 mmol of alkali) per day, divided into three doses, after meals. 1 measuring spoon is taken in the morning, 1 measuring spoon - in the afternoon, and 2 measuring spoons in the evening, while the pH of fresh urine should be in the range of 6.2 - 6.8. If the pH value is below the recommended range, you should increase the daily dose by half a measuring spoon (11 mmol of alkali), adding it to the evening reception of the drug. If the pH value is above the recommended range, the daily dose should be reduced by half a measuring spoon (11 mmol of alkali) by reducing the evening dose. The dose will be considered correctly selected when the pH of fresh urine before taking Uralit-U will be within the recommended range.
To prevent the formation of uric acid stones, it is recommended to regularly check the urine pH.
To prevent the formation of calcium-containing kidney stones: the daily dose is 2 to 3 scoops (= 5 to 7.5 g of granules, which is equivalent to 44 to 66 mmol of alkali) once in the evening. If the pH of urine is too low, 3–4.5 measuring spoons (= 7.5–11.25 g of granules, which is equivalent to 66–99 mmol of alkali) should be taken in 2-3 doses during the day after meals. You should strive to maintain the urine pH of 7.0, while the pH should not fall below 6.2 or rise above 7.4. It is necessary to regularly monitor the concentration of citrates and / or urine pH and adjust the individual dose accordingly (see above).
Measuring urine pH: just before each drug intake, take an indicator paper strip, which is in the package, and, holding it with a clip (also attached), moisten with fresh urine. Then compare the color of the wet strip with the color chart and note the pH value that is printed under the corresponding color. This pH value and the number of taken measuring spoons with granules, recorded in the control calendar. The patient should take a follow-up calendar with each visit to the doctor.

Adverse reactions

Dyspepsia, phosphate nephrourolithiasis.

In all cases, the use of the drug should be part of the overall concept of treatment and prevention (diet, increased fluid intake, etc.). Before starting therapy, it is necessary to conduct examinations aimed at identifying all cases of concomitant diseases that contribute to the formation of kidney stones, in order to exclude them. This also applies to cases of specific therapy (parathyroid adenoma, malignant tumors generating the formation of uric acid stones, etc.). Before the first dose, it is necessary to determine the concentration of electrolytes in the serum and check the kidney function. In addition, if a renal tubular acidosis (PKA) is suspected, the acid-base status should be checked.
Uralit-U contains sunset sunset dye (E 110), which in rare cases can cause allergic reactions, including bronchial asthma in sensitized individuals. Allergic reactions are more often observed in people with hypersensitivity to Acetylsalicylic acid.
Treatment with cytostatics: during treatment with cytostatics, it is advisable to alkalize urine to prevent an increase in uric acid concentration, which is consistent with measures to prevent the formation of uric acid stones. In addition, there is information about the protective effect of alkaline urine pH, which reduces the aggressiveness of cytostatic metabolites, such as isophosphamide derivatives (cyclophosphamide, isophosphamide) and increases the solubility of cytostatics (eg, methotrexate) and their metabolites. The pH values ​​of urine must be maintained at a level not lower than 7.0. In case of later skin porphyria, there is a deficiency of uroporphyrinogen decarboxylase, under the action of which uroporphyrinogen is metabolized to coproporphyrinogen. The purpose of metabolic alkalinization is to prevent the reverse diffusion of coproporphyrin through the renal tubules, which in turn helps to increase the clearance of coproporphyrin. It is believed that as a result of increased elimination of coproporphyrinogen, an increase in the synthesis of coproporphyrinogen from uroporphyrinogen occurs and, as a result, a decrease in the amount of circulating uroporphyrin occurs. The pH value of urine should be 7.2 - 7.5.
Influence on ability to drive motor transport and control mechanisms: missing.

Drug interactions

Any increase in the concentration of extracellular potassium will weaken the effect of cardiac glycosides, while any decrease will enhance the arrhythmogenic effect of cardiac glycosides.Aldosterone antagonists, potassium-sparing diuretics, ACE inhibitors, nonsteroidal anti-inflammatory drugs and non-narcotic analgesics reduce renal excretion of potassium. It should be remembered that 1.0 g of the drug contains 0.172 g or 4.4 mmol of potassium. When following a low-sodium diet, it must be taken into account that 1.0 g of Uralit-U contains 0.1 g or 4.4 mmol of sodium, which is equivalent to 0.26 g of sodium chloride. Preparations containing citrates, while taking it with preparations containing aluminum, can enhance the absorption of aluminum. If you need to take such drugs, the interval between doses of each of them should be at least 2 hours.

Overdosage

Symptoms: in normal kidney function, the likelihood of undesirable effects on metabolic rates is absent even after receiving doses higher than recommended, since the excretion of excess alkali by the kidneys is a natural regulation mechanism that provides an acid-base state.
Treatment: accidental overdose can be eliminated at any time by lowering the dose; if necessary, consult a doctor; as a rule, appropriate measures are taken to treat metabolic alkalosis.

Store at a temperature not higher than 25 ° С.