Uralit-U (potassium-sodium-hydrocitrate complex) granules oral use 280 g. vial

Description

Uralit-U (potassium-sodium-hydrocitrate complex) granules oral use 280 g. vial

Composition

active substance: potassium-sodium-hydrocitrate complex;

1 measuring spoon (2.5 g) of granules contains potassium-sodium-hydrocitrate complex (6: 6: 3: 5) 2.4 g;

Excipients: lemon oil, yellow dye FCF (E 110), purified water.

Dosage form

Granules for oral solution.

Main physical and chemical properties: fine-grained granules of pale orange color with a fragrant odor.

Pharmacotherapeutic group

Means that promote the dissolution of urinary stones.

ATX code G04B C.

Pharmacological properties

Salts of strong bases in combination with weak acids alkalize (neutralize) the pH of urine, while the acid component is metabolized. Excess base, which is formed from alkali ions, is excreted by the kidneys and increases the pH of urine. The citrate ion from alkaline citrates undergoes oxidative metabolic decomposition to CO2 or bicarbonate. Citrate excretion increases, which counteracts the formation of kidney stones.

Neutralization or alkalization of urine can be achieved through oral administration of alkaline citrates; the corresponding response to the drug is dose-dependent.

1 g of potassium-sodium-hydrocitrate complex (8.8 mmol of alkali) increases the pH of urine by 0.2-0.3 units. As a result, the degree of dissociation and, consequently, the solubility of uric acid increases. Dissolution of uric acid stones was confirmed by X-ray method.

Serum bicarbonate concentration (negatively charged excess base) is a regulator of citrate excretion. Negatively charged excess base induces alkalosis by changing the intracellular pH. Alkalosis inhibits the tubular metabolism of citrate in the kidneys, which leads to a decrease in the absorption of citrate and increase its excretion.

Indication

Dissolution of uric acid stones.
Uralit-U prevents the formation (prevention of recurrence) of calcium-containing and uric acid stones, as well as mixed stones that contain calcium oxalate / uric acid or calcium oxalate / calcium phosphate.

Contraindication:

• acute and chronic renal failure;
• severe acid-base imbalance (metabolic alkalosis);
• hyperkalemia;
• hereditary episodic lethargy;
• chronic urinary tract infections caused by bacteria that break down urea;
• low sodium diet;
• hypersensitivity to the ingredients of the drug.

Method of application and dosage

Uralit-U should be administered orally. Before taking the granules should be dissolved in a glass of water and drink. The dose of the drug should be selected individually based on the determination of urine pH values.

To dissolve and prevent recurrence of uric acid stones.

Apply Uralit-U 4 tablespoons (10 g of granules, equivalent to 88 mmol of alkali) per day in three doses after meals. Use 1 tablespoon in the morning, 1 tablespoon in the afternoon and 2 tablespoons in the evening after meals.

The pH of fresh urine should be within the following range: pH 6.2-6.8.

If the pH is below the recommended range, the daily dose should be increased by 0.5 tablespoons (11 mmol of alkali) in the evening. If the pH is above the recommended range, the daily dose should be reduced by 0.5 tablespoons (11 mmol of alkali) in the evening.

The dose is considered to be properly adjusted when the pH of fresh urine before taking Uralit-U is within the recommended range.

Regular urinary pH monitoring is recommended to prevent recurrence of uric acid stones.

To prevent recurrence of calcium-containing kidney stones.

The daily dose should be 2-3 tablespoons (5-7.5 g of granules, equivalent to 44-66 mmol of alkali), which is used once in the evening. If the pH is too low, you should take 3-4.5 tablespoons (7.5-11.25 g of granules, equivalent to 66-99 mmol of alkali) for 2-3 meals after meals.

The pH of the urine should be approximately 7.0. The pH value should not be below 6.2 or above 7.4.

Citrate levels and / or urine pH should be monitored regularly and the individual dose adjusted accordingly.

Urine pH measurement. Immediately before each dose, take the indicator paper strip in the package and, holding it with a clamp (also included), dip it in fresh urine. Then compare the color of the wet strip with the color chart and determine the appropriate pH value.

This is the pH value and the number of measuring spoons with granules to be used, enter in the control calendar. The patient should take a checklist with him every time he visits the doctor.

Children

The drug is not recommended for use in children under 12 years of age, as there is insufficient clinical experience in patients with this age group.

Overdose

Overdose may lead to hyperkalaemia (plasma potassium> 5 mmol / l), especially in patients with concomitant acidosis or renal insufficiency.

With normal renal function, no adverse effects on metabolic parameters are expected, even after doses well in excess of those recommended, as renal excretion of any base triggers a natural regulatory mechanism that maintains acid-base balance in the body.

Any increase in urine pH above the recommended range should never last longer than a few days, as very high pH levels increase the risk of phosphate crystallization and metabolic alkalosis may occur, which is in any case undesirable. Unintentional overdose can be eliminated at any time by reducing the dose; if necessary, appropriate measures should be taken to treat metabolic alkalosis.

Side effects:

• From the digestive tract: moderate pain in the stomach or abdomen.
• Yellow FCF dye (E 110) may cause allergic reactions.