CITROGRAN Effervescent granules Ref.[115315] Active ingredients: Citric acid Sodium bicarbonate Sodium citrate Tartaric acid

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Building 9, Parc du Cap, Mispel Street, Bellville, 7530, Customer Care: 080 222 6662

Product name and form

CITROGRAN (Effervescent granules).

Pharmaceutical Form

Effervescent granules.

White to straw coloured granules with a lemon odour and a sweet/sour slightly lemon taste. After reconstitution with water a clear to straw coloured solution with a slight lemon odour is obtained.

Qualitative and quantitative composition

Each medicine measures (4 g) contains:

Sodium citrate 0,613 g
Sodium bicarbonate 1,716 g
Citric acid anhydrous 0,702 g
Tartaric acid 0,858 g

Contains sugar (liquid glucose) 0,252 mL.

For the 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.

Sodium bicarbonate has antacid properties. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.

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

Flav Lemon permaseal 60301-71
Liquid glucose

Pack sizes and marketing

CITROGRAN effervescent granules are available in round clear glass bottles with a white screw cap and a dosage measure, packed in an outer carton.

CITROGRAN is packed in 60 g or 120 g effervescent granules.

Not all pack sizes may be marketed.

Marketing authorization holder

Building 9, Parc du Cap, Mispel Street, Bellville, 7530, Customer Care: 080 222 6662

Marketing authorization dates and numbers

45/18.3/0182

30 September 2016

Drugs

Drug Countries
CITROGRAN South Africa

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