Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sodium bicarbonate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Sodium Bicarbonate is one of a group of medicines known as alkalinising agents. It is used to correct the acid-alkaline balance in the body. Sodium bicarbonate is used to reduce the amount of acid in the body after a heart attack in patients who have the following conditions: too much acid in their body or too much potassium in their blood. It can also be used to treat patients who have taken too much tricyclic antidepressant medicine. Sodium Bicarbonate will only be used after other resuscitation methods have been attempted.
Sodium Bicarbonate Injection You should not be given Sodium Bicarbonate Injection if:
Your doctor will give you Sodium Bicarbonate Injection by slow injection into the vein (intravenous injection). Your doctor will decide on how much Sodium Bicarbonate Injection you should be given. Adults and the elderly
4. Possible side effects Like all medicines, Sodium Bicarbonate Injection can cause side effects, although not everybody gets them.
include:
Sodium Bicarbonate Injection Keep all medicines out of the sight and reach of children. This Sodium Bicarbonate Injection should not be used after the expiry date which is stated on the carton and ampoule label. The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. This product should only be used in a hospital environment and will be safely disposed of by your doctor.
What Sodium Bicarbonate Injection contains The active substance is Sodium Bicarbonate 8.4%w/v The other ingredients are disodium edetate, nitrogen and water for injections. What Sodium Bicarbonate Injection looks like and contents of the pack Sodium Bicarbonate Injection is a clear, colourless solution supplied in 5ml and 10ml glass ampoules. Each pack contains 10 ampoules. Marketing Authorisation Holder and Manufacturer Martindale Pharma, Bampton Road, Harold Hill, Romford Essex, RM3 8UG, England If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address Product licence number: PL 01883/0023 This leaflet was last revised in August 2018
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Sodium Bicarbonate Injection BP 8.4% w/v comes as injection. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Sodium Bicarbonate Injection BP 8.4% w/v is sodium bicarbonate.
Medicines with the same active substance, strength and form include: Sodium Bicarbonate 8.4% w/v Solution for Injection. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Sodium Bicarbonate Injection BP 8.4% w/v, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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 preexisting 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
The posology depends largely on the extent of the acid-base imbalance. This should be checked regularly
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.
Paediatric population:
The usual dose is 1mmol/kg by slow iv injection. (1ml/kg 8.4% solution)
In premature infants and neonates, the 8.4% solution should be diluted 1:1 with 5% dextrose.
Elderly:
As for adults.
Method of administration
For intravenous administration only.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Conditions where sodium intake is restricted (e.g. renal failure, hypertension, oedema, congestive heart failure)
• Patients with hypoventilation (risk of worsening of acidosis)
• Metabolic or respiratory alkalosis
• Patients with a history of urinary calculi
• Patients with coexistent potassium depletion or chloride depletion, hypocalcaemia and 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.
Administration of sodium bicarbonate to a patient with inadequate minute ventilation can cause worsening of the acidosis.
The treatment of metabolic acidosis must, if possible, be combined with concurrent treatment to combat the primary cause of the acidosis, for example the administration of insulin in uncomplicated diabetes, or blood volume restoration in shock.
In long-term therapy, care is essential to prevent the risk of overdose and alkalosis. Therefore, repeat administrations of fractional doses, or an infusion, should be given while regularly monitoring the acid-base balance and electrolytes. As soon as the most severe symptoms are under control, the dose and frequency of administration must be reduced until normal values have been restored.
There is no evidence to support the use of bicarbonate therapy in the treatment of hypoperfusion-induced lactic academia associated with sepsis.
Sodium Bicarbonate 8.4% w/v Solution for Injection contains sodium
This medicinal product contains 23.00 mg sodium per ml, equivalent to 1.15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
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.
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.
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 haemorrhage (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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Ask anything about Sodium Bicarbonate Injection BP 8.4% w/v. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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