International Medication Systems (UK) Ltd

Sodium Bicarbonate Injection BP Minijet 8.4% w/v. Solution for injection

Sodium Bicarbonate 84mg in 1 ml

Vials contain 840mg/10ml or 4200mg/50ml.

For full list of excipients, see section 6.1.

Solution for injection.

Clear, colourless sterile solution.

For the correction of metabolic acidosis associated with cardiac arrest; especially after other resuscitative measures such as cardiac compression, ventilation, adrenaline or antiarrhythmic agents have been used.

For intravenous administration only.

Adults: the usual dose is 1mmol/kg (2ml/kg 4.2% solution or 1ml/kg 8.4% solution) followed by 0.5mmol/kg (1ml/kg 4.2% solution or 0.5ml/kg 8.4% solution) given at 10 minute intervals.

Children: the usual dose is 1mmol/kg by slow iv injection. In premature infants and neonates, the 4.2% solution should be used or the 8.4% solution should be diluted 1:1 with 5% dextrose.

Elderly: as for adults.

Administration of sodium bicarbonate is contraindicated in patients with renal failure, metabolic or respiratory alkalosis, hypertension, oedema, congestive heart failure, a history of urinary calculi and coexistent potassium depletion or hypocalcaemia, hypoventilation, chloride depletion or hypernatraemia.

Whenever sodium bicarbonate is used intravenously, arterial blood gas analyses, in particular arterial/venous blood pH and carbon dioxide levels, should be performed before and during the course of treatment to minimise the possibility of overdosage and resultant alkalosis.

Accidental extravascular injection of hypertonic solutions may cause vascular irritation or sloughing. The use of scalp veins should be avoided.

Whenever respiratory acidosis is concomitant with metabolic acidosis, both pulmonary ventilation and perfusion must be adequately supported to get rid of excess CO2.

Caution should be used when administering sodium ions to patients receiving corticosteroids or corticotrophin.

Urinary alkalisation will increase the renal clearance of tetracyclines, especially doxycycline but it will increase the half life and duration of action of basic drugs such as quinidine, amphetamines, ephedrine and pseudoephedrine.

Hypochloraemic alkalosis may occur if sodium bicarbonate is used in conjunction with potassium depleting diuretics such as bumetamide, ethacrynic acid, frusemide and thiazides. Concurrent use in patients taking potassium supplements may reduce serum potassium concentration by promoting an intracellular ion shift.

Safe use in pregnancy has not been established. The use of any drug in pregnant or lactating women requires that the expected benefit be carefully weighed against the possible risk to the mother and child.

Patients requiring i.v. sodium bicarbonate are unlikely to be fit enough to breast feed.

Not applicable; this preparation is intended for use only in emergencies.

Alkalosis and/or hypokalaemia may ensue as a result of prolonged use or over-correction of the bicarbonate deficit. Hyperirritability or tetany may occur caused by rapid shifts of free ionised calcium or due to serum protein alterations arising from pH changes.

Symptoms: metabolic alkalosis accompanied by compensatory hyperventilation, paradoxical acidosis of the cerebrospinal fluid, severe hypokalaemia, hyperirritability and tetany.

Treatment: discontinue the administration of sodium bicarbonate, rebreathe expired air or, if more severe administer calcium gluconate especially if tetany is present. In severe alkalosis, an infusion of 2.14% ammonium chloride is recommended, except in patients with pre-existing hepatic disease. If hypokalaemia is present administer potassium chloride.

Sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses clinical manifestations of metabolic acidosis.

Sodium bicarbonate is eliminated principally in the urine and effectively alkalises it.

Not applicable since sodium bicarbonate has been used in clinical practice for many years and its effects in man are well known.

Water for Injection

The addition of sodium bicarbonate to parenteral solutions containing calcium should be avoided except where compatibility has been previously established; precipitation or haze may result, should this occur, the solution should not be used.

5 years. The product should be used immediately after opening. Discard any unused portion.

Do not store above 25°C. Do not refrigerate.

The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications. The 8.4% w/v product is available as 10 or 50ml. Not all pack sizes may be marketed.

For single use only. Discard any remaining contents. The container is specially designed for use with the IMS Minijet injector.

International Medication Systems (UK) Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

PA 255/1/4

Date first granted: PA 08 September 1977

Date renewed: PA 08 September 2007

September 2007

POM