Sodium citrate

Sodium Citrate 0.3M Oral Solution

Sodium Citrate

2.647g of Sodium Citrate in 30ml of Oral Solution

For excipients see 6.1 below

Oral Solution

The product is a clear and colourless solution.

Non-particulate antacid for use by mouth to prior to general anaesthesia for caesarean section.

30ml of a 0.3M solution orally immediately prior to anaesthesia.

Hypersensitivity to the active ingredient or to other ingredients of the product.

Sodium Citrate should not be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia, or hypochlorhydria. Sodium containing salts should be administered extremely cautiously to patients with heart failure, oedema, renal impairment, hypertension, or aldosteronism. (During treatment of acidosis, frequent monitoring of serum-electrolyte concentrations and acid-base status is essential. Alkalinisation of the urine by bicarbonates or bicarbonate precursors leads to increased renal clearance of acidic drugs.) However, urinary alkalinisation prolongs the half-life of basic drugs and may result in toxicity.

Citrates and Citric Acid enhance intestinal aluminium absorption in renal patients which may lead to increased, harmful serum aluminium levels. It has therefore been suggested that patients with renal failure taking aluminium compounds to control phosphate absorption should not be prescribed citrate or citric acid containing products.

As with all antacids, sodium citrate may affect the absorption of many drugs.

Use as indicated above

Not applicable

There are no further effects other than those mentioned in Sections 4.3, 4.4, 4.5 and 4.9 of the Summary of Product Characteristics.

As with all antacids, overdose may produce metabolic alkalosis. The product contains 27mmol of Sodium ions per 30ml and this should be considered. Management of overdose should include monitoring of plasma electrolytes and acid-base status, and general supportive measures.

Sodium citrate has no relevant pharmacodynamic activity other than that caused by its alkalinity (e.g. its gastric acid neutralising capacity).

Sodium citrate is systemically absorbed and renally eliminated, causing metabolic alkalosis and urine alkalisation in sufficient doses.

No further data is provided.

Purified water

Glycerol

Not applicable

2 years

Do not store above 25°C. Store in the original container. Keep the container tightly closed.

For single use only. Discard any remaining solution.

Amber PET bottle with LDPE-lined closure.

None

Macarthys Laboratories Limited T/A Martindale Pharma

Bampton Road,

Romford,

Essex,

RM3 8UG,

United Kingdom

PL 01883/0343

25/08/2005

08/08/2018