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Prescription under medical supervision
- This drug should only be used by well trained personnel in well-equipped hospitals.
- Do not exceed the recommended rate of hyponatraemia correction to minimise the risk of neurologic complications.
Indications
- Severe symptomatic hyponatraemia: serum sodium level < 120 mmol/litre with neurologic involvement (e. g. seizures, confusional state, coma)
- Increased intracranial pressure in traumatic brain injury
- Cerebral oedema
Forms and strengths, route of administration
- 500 ml bag, for IV infusion on central line or large peripheral vein, preferably using an infusion pump.
- DO NOT ADMINISTER BY IV, IM or SC INJECTION.
Composition
- Hypertonic solution of sodium chloride (3 g per 100 ml, 15 g in 500 ml)
- Ionic composition:
- sodium (Na+) 513 mmol (513 mEq) per litre
- chloride (Cl–) 513 mmol (513 mEq) per litre
- Osmolarity: 1027 mOsmol per litre
Dosage and duration
Dosage varies according to patient’s underlying condition, severity of symptoms, clinical response and serum sodium level. For information:
Severe symptomatic hyponatraemia
- Child under 50 kg: 3 ml/kg over 20 minutes
- Child 50 kg and over and adult: 150 ml over 20 minutes
Check clinical response and serum sodium level. Repeat infusion up to 2 times if necessary during the first hour, until symptoms improve or serum sodium increases by 5 mmol/litre.
Further correction of hyponatremia is based on serum sodium deficit calculation, to reach 130 mmol/litre.
Do not increase serum sodium by more than 10 mmol/litre in the first 24 hours and 8 mmol/litre per 24 hours thereafter.
Increased intracranial pressure in traumatic brain injury, cerebral oedema
- Child and adult: 3 ml/kg over 10 to 20 minutes
Repeat infusion up to 2 times if necessary, according to clinical response.
Contra-indications, adverse effects, precautions
- Administer with caution and under close supervision:
- to infants and older patients;
- to patients with conditions associated with sodium or fluid retention (hypertension, heart failure, peripheral or pulmonary oedema, renal impairment, hepatic impairment with cirrhosis, pre-eclampsia, etc.) or taking drugs that increase the risk of sodium or fluid retention (e.g. corticosteroids);
- if serum sodium > 160 mmol/litre or serum osmolarity > 320 mOsm/litre.
- May cause:
- pain at infusion site, venous irritation, phlebitis, necrosis in the event of extravasation;
- nausea, vomiting, diarrhoea, dry eyes and mouth, thirst, headache;
- electrolytes disturbances (hypernatraemia, hypokalaemia, hyperchloraemia) and acid-base imbalance;
- in the event of too rapid infusion and/or overcorrection of hyponatraemia:
- peripheral or pulmonary oedema;
- osmotic demyelination syndrome (signs and symptoms include dysphagia, confusional state, slurred speech, movement disorders, lethargy, muscle weakness and coma).
- Closely monitor:
- infusion rate; use an infusion pump to prevent unintentional bolus;
- infusion site for redness and inflammation;
- clinical and neurologic state, serum sodium level (and other electrolytes if possible);
- urine output: a sudden increase to more than 100 ml/hour may be an early sign of hyponatraemia overcorrection.
- Pregnancy and breast-feeding: administer only if clearly needed.
Remarks
- Do not use as a vehicle for administering injectable drugs, use 0.9% sodium chloride.
- 3% sodium chloride is not included in the WHO list of essential medicines.
Storage
Below 25 °C