1. Name Of The Medicinal Product
Sodium Bicarbonate Injection BP Minijet 4.2% w/v
2. Qualitative And Quantitative Composition
Sodium Bicarbonate BP 4.2% w/v
3. Pharmaceutical Form
Sterile aqueous solution for parenteral administration to humans.
4. Clinical Particulars
4.1 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.
4.2 Posology And Method Of Administration
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.
4.3 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.
4.4 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.
4.5 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.
4.6 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.
4.7 Effects On Ability To Drive And Use Machines
Not applicable; this preparation is intended for use only in emergencies.
4.8 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.
4.9 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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses clinical manifestations of metabolic acidosis.
5.2 Pharmacokinetic Properties
Sodium bicarbonate is eliminated principally in the urine and effectively alkalises it.
5.3 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.
6. Pharmaceutical Particulars
6.1 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.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications.
The 4.2% w/v is available as 10ml.
6.6 Special Precautions For Disposal And Other Handling
The container is specially designed for use with the IMS Minijet injector.
Administrative Data
7. Marketing Authorisation Holder
International Medication Systems (UK) Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
UK
8. Marketing Authorisation Number(S)
PL 3265/0001R
9. Date Of First Authorisation/Renewal Of The Authorisation
Date first granted: 28 February 1991
Date renewed: 29 November 1996
10. Date Of Revision Of The Text
April 2001
POM
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