Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Sodium Bicarbonate Injection BP 8.4% w/v

⚠ This medicine appears to have been discontinued

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.

Active substance: Sodium bicarbonate

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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.

What you need to know before you take it

Sodium Bicarbonate Injection You should not be given Sodium Bicarbonate Injection if:

  • you are allergic to Sodium Bicarbonate or any of the other ingredients of this medicine, (listed in section 6)
  • your breathing is slower or more shallow than usual (hypoventilation)
  • you have any blood abnormalities such as high levels of sodium, low levels of calcium, potassium or chloride, or your blood is less acidic than usual (your doctor will need to check this)
  • you have had kidney stones
  • you have high blood pressure
  • you have kidney failure
  • you have heart failure
  • you suffer from fluid retention If any of the above apply to you or your child please tell your doctor or nurse before you are given Sodium Bicarbonate Injection. Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given Sodium Bicarbonate Injection. Your doctor or nurse may want to regularly check your blood acid levels during the course of treatment with this medicine. Other medicines and Sodium Bicarbonate Injection Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Including:
  • corticosteroids or corticotropin (medicines used to reduce swelling or to treat hormone problems)
  • medicines used to treat infections (tetracyclines) such as doxycycline
  • quinidine, flecainide (medicines used to treat heart problems)
  • amphetamines (medicines used to treat certain mental disorders and drowsiness)
  • ephedrine and pseudoephedrine (medicines used to treat colds and asthma)
  • potassium supplements
  • medicines used to treat water retention and problems with passing urine such as ethacrynic acid, bumetanide, thiazides or frusemide
  • medicines used to treat high blood pressure (e.g mecamylamine)
  • medicines used to treat Alzheimers disease (e.g. memantine)
  • medicines used to treat diabetes mellitus (e.g. chlorpropamide)
  • medicines used to treat mood disorders (e.g. lithium)
  • Aspirin (Acetylsalicylic acid) Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before taking this medicine. Sodium Bicarbonate 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 2g sodium for an adult. Driving and using machines This medicine is unlikely to affect your ability to drive or use machines.

How to take it

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

  • The usual starting dose is 1mmol for every kg you weigh
  • Followed by 0.5 mmol/kg given at 10minute intervals Children
  • The usual dose is 1 mmol for every kg you weigh given by slow IV injection
  • The medicine should be diluted 1:1 with 5% dextrose for premature infants and new-borns. If you think you have been given too much Sodium Bicarbonate Injection As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much. Your doctor has information on how to recognise and treat an overdose. If you are concerned about your treatment please talk to your doctor. Signs of too much sodium bicarbonate include hyperventilation (over breathing), very sensitive to slight stimuli, twitching and high potassium levels in your blood which may cause you to feel dizzy or tired.

4. Possible side effects Like all medicines, Sodium Bicarbonate Injection can cause side effects, although not everybody gets them.

Possible side effects

include:

  • Low levels of potassium causing twitching, muscle weakness, 'pins and needles' in the hands or feet, irritability or abnormal heart rhythm
  • Low levels of blood sugar and high concentration of sodium in the blood causing feeling hungry, thirsty, nervous, confused, extreme irritation, increased urination, shakiness or sweating
  • Too much acid in the blood, which many cause an increased rate of breathing ( intracellular acidosis)
  • a blood disorder consisting of an increase in the volume of circulating blood
  • Low levels of calcium causing involuntary contraction of your muscles
  • Swelling due to a build-up of fluid under the skin
  • New born babies may have bleeding inside the skull
  • Sodium bicarbonate may leak out of the veins into the surrounding tissue. This may cause pain,redness or irritation to the skin
  • If the medicine is not correctly injected it could cause the skin to die around the injection site. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

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.

Contents of the pack and other information

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

D0422100000

100mm Measurement Verification Bar

4221-C

Frequently asked questions about Sodium Bicarbonate Injection BP 8.4% w/v

How do I take Sodium Bicarbonate Injection BP 8.4% w/v?

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.

What is the active substance in Sodium Bicarbonate Injection BP 8.4% w/v?

The active substance in Sodium Bicarbonate Injection BP 8.4% w/v is sodium bicarbonate.

Are there equivalent medicines to Sodium Bicarbonate Injection BP 8.4% w/v?

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.

Where does this information come from?

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.

Can I get Sodium Bicarbonate Injection BP 8.4% w/v without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Sodium bicarbonate (38 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. 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 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.

4.2. Posology and method of administration

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.

4.3. Contraindications

• 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.

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.

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.

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 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.

4.6. Fertility, 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

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.

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

💬 Ask about this leaflet

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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