URALYT-U Granules Ref.[115338] Active ingredients: Citric acid Potassium citrate Sodium citrate

To ensure success it is essential to follow the instructions carefully. Best results can only be obtained by close co-operation on the part of the patient.

The treatment is divided into two stages:

1. Initial adjustment of the dose of Uralyt-U to a level which brings the pH of the urine into the desired range.

2. Long term administration of Uralyt-U, with regular checks by the patient.

The granules should be dissolved by stirring in half a glass of water or fruit juice and taken, preferably, after meals. Unused solution must be discarded.

The dosage of Uralyt-U is adjusted in accordance with the pH value of the urine. This is done as follows:

1. Measure the pH of the urine with the indicator paper.

2. Enter the pH value (colour number) on the enclosed test chart.

3. Take the corresponding dose (number of measuring spoonfuls of Uralyt-U) and enter it on the chart.

Check the pH value of the urine before each dose of Uralyt-U.

This pH value (5,6; 5,9; 6,2;6,5; 6,8; 7,0; 7,2; 7,4; 7,7; 8,0) shows the response from the previous dose of Uralyt-U.

The morning test shows the response from the previous evening dose, the midday test shows the response from the morning dose, etc.

Posology

How to take Uralyt-U

The enclosed measuring spoon holds approximately 2,5 g of the granules.

For most patients it has proved satisfactory to take an average daily dose of 4 measures of the granules (10 g Uralyt-U) spread uniformly throughout the day in accordance with the following schedule:

This is the standard dosage to stabilise the urine pH within the desired range (6,2 to 6,8) and is the range required for treatment of Uric Acid Calculi.

During treatment with uricosuric agents the pH and is stabilised between 6,2 and 6,8.

During cytostatic therapy the urine pH should be at least 7,0.

The dose should be individually adjusted in accordance with the pH recorded. It should, however, be noted that any necessary correction of the dose is done on the following day.

Examples:

If at midday the pH value is found to be too high (7,0 or more) there is no point in immediately cutting down the next dose. A test result of “7,0 or more” at midday means that the morning dose was too high. The right course is to reduce the next morning dose so that the pH response at next midday will then fall within the correct range. The same applies to other recordings.

If the morning pH is found to be too low (e.g. 5,9), this means that too small a dose of the granules was taken on the previous evening. Therefore, the next evening dose should be increased.

When changing the dose, it is advisable to increase or decrease it in steps of half a spoonful only.

How to use the indicator paper and test chart

The pH of fluid is a measure of its acidity or alkalinity. For example, pH 7,0 means that the fluid is neither acid nor alkaline – in other words, neutral. pH readings above 7,0 mean that the reaction is increasingly alkaline, while pH values below 7,0 mean increasing acidity. pH values are measured directly by colour changes on the prepared paper strips (indicatory papers).

The special indicator paper (enclosed) consists of 52 perforated yellow paper strips and a colour scale with pH number. Every morning, at midday and in the evening, before taking Uralyt-U, tear off one paper strip and dip it into the fresh urine for a few seconds.

Alternatively, it may be held in the urine stream.

Match the change in colour of the strip at once with the colour scale and mark the corresponding colour number by placing a cross in the appropriate space on the test chart (morning, midday, evening).

Then enter the dose of the granules by writing the number of measuring spoonsful in the space directly after the time.

When the dose has been correctly adjusted, the test which is carried out three times a day before each dose, will give colour numbers of 6,2; 6,5 or 6,8.

If the colour number is over 7,0 reduce the dose, except during cytostatic therapy, when the urine pH should be at least 7,0.

Conversely, underdosage is indicated by colour numbers less than 6,2 (5,6 or 5,9). In this case the dosage must be increased.

If the colour number is 6,2 it may be assumed that the dose is correct. The aim should always be to keep within the 6,5 to 6,8 range; 7,0 is to be considered the upper limit.

Method of administration

For oral use.

Symptoms

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 overdosage can be corrected at any time by reducing the dose. If necessary, appropriate measures for the treatment of metabolic alkalosis may be considered.

Management

Treatment is symptomatic and supportive.

60 months.

Store in a dry place at room temperature (below 25ºC).

Keep container tightly closed.

Screw top container containing 280 g granules.

No special requirements.