SODIUM BICARBONATE

Posology Correction of metabolic acidosis Correction of metabolic acidosis should not be effected too rapidly. It is advisable to start administering only half of the calculated dose and adjust further doses according to the actual results of blood gas analysis.

The dose depends on the degree of the disorder of the acid-base status. 2 corresponds to the proportion of the extracellular fluid in relation to total body weight). 4% w/v) are to be given.

Maximum daily dose:

According to the correction requirements. 5 mmol of sodium bicarbonate per kg body weight per hour. Paediatric population The dosage has to be adjusted individually. The first dose can be up to 1 mmol/kg body weight, administered by slow intravenous infusion.

In newborns and children under 2 years: the daily dose should not exceed 5 mmol per kg body weight per day, administered by slow intravenous infusion. 4). Urine alkalinisation For urine alkalinisation the dose is adjusted according to the desired pH of the urine and administration should be accompanied by monitoring of the acid-base balance, the water balance and the electrolyte balance.

Care should be taken not to exceed the maximum infusion rate stated above. 5-2 times the maintenance fluid rate. 5.

Method of administration:

Intravenous use. For central venous infusion only.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

General Sodium Bicarbonate should only be administered with particular caution in presence of the following conditions: • respiratory acidosis • hypocalcaemia • increased serum osmolarity • further in all situations where sodium intake must be restricted, like cardiac insufficiency, oedema, hypertension, eclampsia, severe kidney insufficiency.

When respiratory acidosis is concomitant with metabolic acidosis, both pulmonary ventilation and perfusion must be adequately supported to ensure adequate elimination of excess CO2. Administration of Sodium Bicarbonate may lead to sodium and fluid overload.

Accidental paravenous administration may lead to tissue necrosis. It must be made absolutely sure that the solution is infused intravenously; accidental intra-arterial infusion may cause shock or loss of an extremity. 4 % w/v Sodium Bicarbonate Intravenous Infusion may cause vein irritation and consecutively phlebitis or thrombosis on account of its alkalinity and its high osmolarity.

Patient monitoring should include regular checks of the acid-base balance, the serum electrolyte concentrations and the water balance. Correction of the acid-base status is always associated with shifts of the electrolyte balance. In particular, the potassium balance is affected.

Alkalinisation or correction of acidosis promote the potassium influx into cells and may therefore lead to hypokalaemia. Potassium or calcium deficiencies should be corrected before beginning of the alkalinising therapy. The effects of bicarbonate on organ function, complication rates and survival in diabetic ketoacidosis, cardiac arrest and lactic acidosis have not been investigated sufficiently.

Caution is advised when using sodium bicarbonate in these conditions. Paediatric population Newborns and children under 2 years: rapid infusion (10 ml/min) of hypertonic sodium bicarbonate solutions may produce hypernatraemia, a decrease in cerebrospinal fluid pressure and (in preterm infants) possible intracranial haemorrhage.

2).

1 • Respiratory and metabolic alkalosis • Hypoventilation (risk of worsening acidosis) • Hypernatraemia • Hypokalaemia • Excessive chloride loss