Sodium Bicarbonate Injection

Sodium Bicarbonate Injection

Product Name:Sodium bicarbonate injection

Nombre del Producto: Bicarbonato de sodio solución Inyectable

Specification: 8.4% 20ml

Package: 10amps/box, 50amps/box

Standard: USP & CP

Details

Sodium bicarbonate injection

Therapeutic indications

Sodium Bicarbonate Injection is indicated in adults and children for:

• Correction of metabolic acidosis associated with cardiac arrest in patients with pre- existing metabolic acidosis

• Cardiac arrest associated with hyperkalaemia with pre-existing metabolic acidosis

• Life threatening hyperkalaemia with pre-existing metabolic acidosis

• Tricyclic antidepressant overdose.

Sodium bicarbonate should only be used after other resuscitative measures such as cardiac compression, ventilation, adrenaline and antiarrhythmic agents have been attempted.

In neonates, Sodium Bicarbonate is indicated for:

• Correction of metabolic acidosis associated with cardiac arrest in patients with pre- existing metabolic acidosis

• Cardiac arrest associated with hyperkalaemia with pre-existing metabolic acidosis

• Life threatening hyperkalaemia with pre-existing metabolic acidosis

No benefits have been demonstrated from the routine use of sodium bicarbonate in resuscitation of neonates. In neonates, sodium bicarbonate is recommended in resuscitation only in cases of prolonged cardiac arrest, irresponsive to other therapy, after establishment of adequate ventilation and circulation.

 

Posology and method of administration

Posology:

The posology depends largely on the extent of the acid-base imbalance. This should be checked regularly. Administration is via slow intravenous injection.

For intravenous administration only.

Adults:

The usual dose is 1mmol/kg (1ml/kg 8.4% solution) followed by 0.5mmol/kg

(0.5ml/kg 8.4% solution) given at 10 minute intervals.

Children:

The usual dose is 1mmol/kg by slow iv injection. (1ml/kg 8.4% solution)

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.

 

Contraindications

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.

 

Special warnings and precautions for use

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.

 

Interaction with other medicinal products and other forms of interaction

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

Urinary alkalisation will increase the renal clearance of medicinal products which are acid in nature e.g. tetracyclines, especially doxycycline, acetylsalicylic acid, chlorpropamide, lithium, methenamine. It increases the half life and duration of action of basic drugs such as quinidine, amphetamines, ephedrine, pseudoephedrine, memantine and flecainide. Sodium bicarbonate is known to increase renal tubular reabsorbtion of mecamylamine causing hypotention.

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.

 

Pregnancy and lactation

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.

 

Effects on ability to drive and use machines

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

 

Undesirable effects

Metabolism and nutrition disorders:

Alkalosis, hypokalaemia, hypernatremia, hyperosmolarity, hypocalcemia, hypoglycemia, paradoxical intracellular acidosis.

Cardiac disorder:

Deterioration of hemodynamic status associated with volume overload.

Nervous system disorders:

Intracranial hemorrhage (in neonates), hyperirritability or tetany.

General disorders and administration site conditions: Extravasation.

Incorrect administration (intra-arterial, paravenous) may cause tissue necrosis.

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. 

 

Overdose

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 pe-existing hepatic disease. If hypokalaemia is present administer potassium chloride.


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