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

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2025  Publisher: Viatris South Africa (Pty) Ltd, 4 Brewery Street, Isando, Johannesburg, 1609

Product name and form

URALYT-U granules.

Pharmaceutical Form

Pale orange granules with an aromatic odour and a salty taste.

Qualitative and quantitative composition

One measuring spoon (2,5 g granules) contains:

2,43 g potassium sodium hydrogen citrate (6:6:3:5)

Equivalent to:

11 mEq potassium
11mEq sodium
27 mEq citrate

Sugar free.

For full list of excipients see section 6.1.

Active Ingredient

Potassium citrate is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, uric acid lithiasis with or without calcium stones. When potassium citrate is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, potassium citrate therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate.

Citrate and citric acid solutions are systematic and urinary alkalinizers thereby providing symptomatic relief of dysuria.

Sodium citrate has no relevant pharmacodynamic activity other than that caused by its alkalinity (e.g. its gastric acid neutralising capacity). Sodium citrate is a non-particulate antacid for use by mouth to prior to general anaesthesia for caesarean section.

List of Excipients

The other ingredients in Uralyt-U granules are:

Oil of lemon
Purified water
Sunset Yellow FCF E110 C.I. No. 15985

Pack sizes and marketing

Screw top container containing 280 g granules.

Marketing authorization holder

Viatris South Africa (Pty) Ltd, 4 Brewery Street, Isando, Johannesburg, 1609

Marketing authorization dates and numbers

H/18.4/1773

16/05/1995

Drugs

Drug Countries
URALYT-U South Africa

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