Presentation and Status in Health Basket
Dissolution and metaphylaxis of uric acid stones: In general, take 4 measuring spoonfuls (= 10 g granules equivalent to 88 mmol alkali) daily divided into three doses, after meals. Take 1 measuring spoonful every morning, 1 measuring spoonful at midday and 2 measuring spoonfuls every evening. The pH of the fresh urine should be within the range of pH 6.2 – 6.8. If the pH reading is below the recommended zone, the daily dose should be increased by half a measuring spoonful Uralyt-U (11 mmol alkali) in the evening. If the pH reading is above the recommended zone, the daily dose should be reduced by half a measuring spoonful (11 mmol alkali) in the evening. The correct dose has been reached if the pH of the fresh urine, before taking the dose of Uralyt-U, is within the recommended range. 2 For metaphylaxis of uric acid stones, regular checks of the urine pH are advisable.
Metaphylaxis of calcium-containing renal calculi: The daily dose should be 2 – 3 measuring spoonfuls (= 5 – 7.5 g granules equivalent to 44 mmol – 66 mmol alkali) and should be taken in a single dose in the evening. If the pH reading is too low, 3 – 4.5 measuring spoonfuls (= 7.5 g – 11.25 g granules equivalent to 66 mmol – 99 mmol alkali) should be taken in 2-3 doses divided over the day, after meals. A urine pH reading of 7.0 should be aimed at. The pH should not fall below pH 6.2 and should not rise above pH 7.4. Citrate levels and/or urine pH readings should be regularly checked and the individual dose (see above) adjusted accordingly.
To dissolve uric acid calculi in urinary tract and prevent further stone formation.
In the patient information leaflet it is pointed out to the patient that Uralyt-U should not be used: In cases of acute or chronic renal failure, In metabolic alkalosis, Hyperkalemia, With Adynamia episodica hereditaria, In chronic urinary tract infections with urea-splitting bacteria (danger of generation of struvit stones), In low sodium diet, In case of increased sensitivity against ingredients of Uralyt-U.
Note: The treatment of children less than 12 years of age is not recommended as there is not enough clinical experience for this age group.
Before starting therapy all circumstances/malconditions that may be in favour of urinary stones should be excluded. The same is true if there exists a specific therapy (adenoma of parathyroid glands, malignoma with generation of uric acid stones etc.). The recommended daily dose is 11.25 g granulate (4.5 measuring spoons). This corresponds to 1.86 g potassium and 1.09 g sodium, i. e. 47.5 mmol potassium and 47.5 mmol sodium. This should be considered in the elderly and at simultaneous therapy with potassium-saving diuretics, aldosterone antagonists, ACE-inhibitors, angiotensin receptor antagonists, non-steroidal anti-inflammatory drugs or peripheral analgesics. Interaction with these medicinal products can lead to hyperkalemia. Before taking the first dose the serum electrolytes should be determined and renal function should be monitored. Furthermore, the acid base status should be checked when renal tubular acidosis (RTA) is suspected. Be cautious with the use of Uralyt-U in patients with severe disturbances of liver function. This drug contains the colouring agent yellow orange S (E110) which may induce allergic reactions including asthma in a sensitized person. Allergy is more often seen in people reacting to 2- acetoxybenzoic acid (acetylsalicylic acid).
Gastrointestinal disorders: Mild gastric or abdominal pain are common. Mild diarrhoea and nausea are rare. Other possible adverse reactions: Yellow orange S (E110) which may provoke allergic reactions.
Any increase in extracellular potassium concentration will weaken the effect of cardiac glycosides, while any decrease will potentiate the arrhythmogenic effect of cardiac glycosides. Aldosterone antagonists, potassium-saving diuretics, ACE inhibitors, angiotensin receptor antagonists, nonsteroidal anti-inflammatory drugs and peripheral analgesics diminish renal potassium excretion. Remember that 1.0 g potassium-sodium-hydrogencitrate contains 0.172 g or 4.4 mmol potassium. When prescribing a low sodium diet, please remember that 1.0 potassium-sodium-hydrogencitrate contains 0.1 g or 4.4 mmol sodium, equivalent to 0.26 g sodium chloride. Drugs containing citrate given at the same time as drugs containing aluminium can cause an increase in aluminium absorption; if such drugs have to be taken, an interval of at least 2 hours must be allowed between taking each kind of drug.
Pregnancy and Lactation
There are not enough clinical data about the use of Uralyt-U in pregnant women. Experimental studies in animals did not reveal any hints of teratogenic or embryotoxic effects. As the active ingredient is a combination of physiologically occurring substances, Uralyt-U may be used in pregnancy and lactation under the indicated dose recommendations. Hints for harmful effects during pregnancy and lactation are not known.
Overdose can lead to Hyperkalemia (potassium-plasma level >5 mmol/l), especially in patients with simultaneous acidosis or renal failure. Provided that renal function is adequate, there is no likelihood of any unwanted effects on normal metabolic parameters, even after taking doses higher than those recommended, since the excretion of any base excess by the kidney provides a natural regulatory mechanism which ensures maintenance of acid-base balance. Any rise above the recommended urine pH-range should in no circumstances be allowed to persist for more than a few days, since at considerably high pH levels there is an increased risk of phosphate crystallisation and the long-term establishment of a definite alkalotic metabolic state is in any case undesirable. Inadvertent overdose can be corrected at any time by reducing the dose: if necessary appropriate measures for the treatment of metabolic alkalosis may be considered.