Uralit-U, 280 g

– For dissolution of uric acid stones.

– For prevention (prevention of recurrence) of formation of calcium and uric acid stones, as well as mixed stones – calcium oxalate/uric acid or calcium oxalate/calcium phosphate.

Active ingredient

Composition

In a scoop ( 2.5 g) of pellets for preparation of a solution for oral administration contains:

the active ingredient:

Potassium sodium-hydrogen citrate 2.4277 g.

auxiliary substances:

Hydrate water of the active ingredient 67.3 mg,

Sunset dye (E 110) 0.2 mg,

Lemon oil 4.8 mg.

How to take, the dosage

The pellets should be dissolved in a glass of water and drunk.

For dissolving and preventing recurrence of urate stone formation: usually take 4 scoops (= 10 g pellets, equivalent to 88 mmol of alkaline) per day, divided into three meals, after meals. One scoop is taken in the morning, one scoop in the afternoon, and two scoops in the evening, and the pH of fresh urine should be between 6.2 and 6.8. If the pH is below the recommended range, increase the daily dose by half a scoop (11 mmol alkaline), adding it to the evening dose. If the pH is above the recommended range, the daily dose should be reduced by half a scoop (11 mmol alkaline) by reducing the evening dose. The dose will be considered properly adjusted when the pH of fresh urine before taking Uralit-A is within the recommended range.

In order to prevent the formation of urate stones, regular checking of urine pH is recommended.

To prevent calcium-containing kidney stones: the daily dose is 2 to 3 scoops (= 5 to 7.5 g pellets, equivalent to 44 to 66 mmol alkaline) once in the evening. If urine pH is too low, 3 to 4.5 scoops (= 7.5 to 11.25 g pellets, equivalent to 66 to 99 mmol alkaline) should be taken in 2-3 times during the day after meals. You should aim to maintain urine pH at 7.0, and the pH should not fall below 6.2 or rise above 7.4. The concentration of citrate and/or urine pH should be monitored regularly and the individual dose should be adjusted accordingly (see above).

Measurement of urine pH: just before each administration of the drug, take the indicator paper strip, which is in the package, and, holding it with a clamp (also included), wet it with fresh urine. The color of the wet strip is then compared to the color chart and the pH value printed below the corresponding color. This pH value and the number of measuring spoonfuls of pellets taken are recorded in the control calendar. The patient should take the control calendar with them every time they visit the doctor.

Interaction

Any increase in extracellular potassium concentration will attenuate the effect of cardiac glycosides, while any decrease will increase the arrhythmogenic effect of cardiac glycosides.

Aldosterone antagonists, potassium-saving diuretics, ACE inhibitors, nonsteroidal anti-inflammatory drugs, and non-narcotic analgesics reduce renal potassium excretion.

Please remember that 1.0 g of the drug contains 0.172 g or 4.4 mmol of potassium. When following a low-sodium diet, note 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.

Drugs containing citrate may increase aluminum absorption when taken concomitantly with drugs containing aluminum. If intake of these drugs is necessary, an interval of at least 2 hours between doses of each of them should be observed.

Special Instructions

In all cases, the use of the drug should be part of an overall treatment and prevention concept (diet, increased fluid intake, etc.). Before starting therapy, all cases of concomitant diseases contributing to the formation of kidney stones should be examined in order to rule them out.

This also applies to cases of specific therapy (adenoma of parathyroid glands, malignant tumors generating uric acid stones, etc.). Before the first intake, serum electrolyte concentrations should be determined and renal function should be checked. In addition, if renal tubular acidosis (RCA) is suspected, acid-base status should be checked.

Uralit-U contains sunset dye (E 110), which in rare cases may cause allergic reactions, including bronchial asthma in sensitized persons. Allergic reactions are more common in people with hypersensitivity to acetylsalicylic acid.

Treatment with cytostatics: During treatment with cytostatics, it is advisable to perform urine alkalinization to prevent an increase in uric acid concentration, which is consistent with measures to prevent uric acid stone formation. In addition, there is evidence of 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 (such as methotrexate) and their metabolites. Urine pH values should be maintained at or above 7.0. In cutaneous porphyria, there is a deficiency of uroporphyrinogen decarboxylase, which metabolizes uroporphyrinogen into coproporphyrinogen.

The purpose of metabolic alkalinization is to prevent reverse diffusion of coproporphyrin through the renal tubules, which in turn helps to increase coproporphyrin clearance. Increased excretion of coproporphyrinogen is thought to result in increased synthesis of coproporphyrinogen from uroporphyrinogen and, as a consequence, a decrease in the amount of circulating uroporphyrin. The urine pH value should correspond to 7.2 – 7.5.

Impact on ability to drive motor transport and operate mechanisms: none.

Contraindications

– Hypersensitivity to the components of the drug.
– Acute or chronic renal failure.
– Metabolic alkalosis.
– Hereditary episodic adynamia.
– Chronic urinary tract infections caused by bacteria that break down urea (risk of struvite stones).
– Diet with low content of table salt.
– Acute dehydration.
– Patients who have combined urine pH above 7 with poorly controlled diabetes mellitus or with insufficiency of adrenal function.
– Use in children under 12 years of age is not recommended because there is insufficient clinical experience regarding this age group.

The drug Uralit-U is used with caution in patients with severe liver dysfunction.

Side effects

Dyspepsia, phosphate nephrolithiasis.

Overdose

Symptoms: with normal renal function, there is no chance of adverse effects on metabolic parameters even after doses higher than recommended, since excretion of excess alkaline by the kidneys is a natural regulatory mechanism that ensures acid-base status.

Treatment: accidental overdose can be corrected at any time by reducing the dose; if necessary, a physician should be consulted and appropriate measures to treat metabolic alkalosis are usually used.