SODIUM CHLORIDE

Posology The recommended dosing regimen has been empirically derived. It is therefore important that dosage selection should be adjusted according to the age, weight, the extent of sodium deficit and clinical condition of the patient.

Adults (including the elderly):

A typical oral replacement dose of sodium chloride in chronic salt-losing conditions is about 40-80 mmol (8ml-16ml) of sodium daily, given as divided doses. Serum sodium concentration in patients should be raised by not more than 10 mmol/L to 12mmol/L of body water during the first 24 hours of treatment or 18 mmol/L/48 hours should be observed.

Paediatric population Dosage in children (1 month to 18 years) should be adjusted to individual’s need. 4ml/kg) in divided doses over a 24 hour period. Neonates Treatment with Sodium Chloride 5mmol/ml Oral Solution should only be initiated under the supervision of specialist paediatric physicians.

Dosage should be adjusted if necessary according to clinical need and after plasma sodium monitoring. 3 to 5 mmol per kg daily in divided doses. Dosages can be adjusted according to patient requirements. Example dilutions are 2 mmol diluted in 100ml formula feed, or 3 to 4 mmol diluted in 100 ml breast milk.

Always ensure the product is added and thoroughly mixed into the drink, breast milk or formula feed immediately before administration. Renal impairment Dose adjustment may be necessary depending on the clinical condition of the patient and close monitoring of serum sodium levels.

Method of administration For oral administration. The oral solution may be diluted in a glass of water or baby’s bottle. Sodium chloride solutions should not be used to induce emesis as there is a danger of induction of hypernatraemia.

g. post-operatively and in patients with impaired cardiac or renal function) may cause hypernatraemia. The most serious effects of hypernatraemia is caused by osmotically induced water shifts that decrease intracellular volume, resulting in dehydration of internal organs, especially the brain.

Dehydration of the brain may cause somnolence and confusion, progressing to convulsions, coma, respiratory failure, and death. The main safety concern associated with the treatment of hyponatraemia concerns over rapid and over correction of sodium serum levels.

In such cases, there is an osmotic shift of water out of the body’s cells, in the case of the brain leading to the uncommon but potentially life-threatening condition known as osmotic demyelination syndrome in which axonal damage occurring in characteristic pontine areas can give rise to features such as quadriparesis and cognitive changes.

This syndrome is a serious, sometimes fatal demyelinating disorder of the central nervous system that all forms of sodium chloride: hypertonic saline, isotonic saline, sodium chloride given orally, and even water restriction alone, have been causally associated with it.

General adverse effects of sodium chloride excess in the body are as follows. MedDRA System Organ Class Frequency Adverse Reaction Gastrointestinal disorders Not known* Swollen tongue, nausea, vomiting, diarrhoea, abdominal cramps, thirst, and reduced salivation Nervous system disorders Not known* Irritability, headache, dizziness, weakness, convulsions and coma Eye disorders Not known* Reduced lacrimation Cardiac disorders Not known* Tachycardia, cardiac failure Vascular disorders Not known* Hypertension, hypotension General disorders and administration site conditions Not known* Fever, sweating, restlessness, irritability, weakness, muscular twitching and rigidity *Frequency cannot be estimated from the available data Administration of large doses may give rise to sodium accumulation, oedema, and hyperchloraemic acidosis.

Sodium Chloride should be administered with caution to patients with hypertension, heart failure, peripheral and pulmonary oedema, renal impairment, pre-eclampsia, if you are on a low salt diet or other conditions associated with sodium retention.

Patients with the above mentioned conditions should be monitored frequently during the period of medication with Sodium chloride oral solution. In addition, care is also required when administering this solution to very young or elderly patients.

Sodium chloride is contraindicated in any situation where salt retention is undesirable, such as oedema, heart disease, cardiac decompensation and primary or secondary aldosteronism; or if you are taking medication that causes salt and water loss from the body.