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Description:
5% Sodium Bicarbonate Injection, USP (sodium bicarbonate (sodium bicarbonate 5% injection) 5% injection) is a sterile, nonpyrogenic solution of Sodium Bicarbonate (sodium bicarbonate 5% injection), USP in Water for Injection, USP. It contains no antimicrobial agent. Composition, osmolarity, pH and ionic concentration are shown below.
Therapeutic Indications
For the correction of metabolic acidosis associated with cardiac arrest after other resuscitative measures such as cardiac compression, ventilation, adrenaline and antiarrhythmic agents have been used.
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 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.
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
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.
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.
Pharmacodynamic Properties
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.
Preclinical Safety Data
Not applicable since sodium bicarbonate has been used in clinical practice for many years and its effects in man are well known.
List of Excipients
Water for Injection USP
6.2 Incompatibilities
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.
Special Precautions for Storage
Store below 25°C. |
Pharma Sources Insight APRIL 2023
