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.
Sodium Bicarbonate 8.4% w/v solution for infusion
⚠ 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.
What it is and what it is used for
for This medicine contains sodium bicarbonate (bicarbonate of soda) , a substance that is able to neutralize acidic substances. Sodium Bicarbonate 8.4% w/v is used:
- to neutralize excess acidic (=sour) substances in the blood
- to render the urine more basic (or alkaline) in the case of poisoning with acidic substances, e.g. barbiturates or acetylsalicylic acid, in order to accelerate their excretion
- to render the urine more basic (or alkaline) in order to make some drug substances, e.g. methotrexate, sulphonamides, more soluble to improve their excretion in urine
- to render the urine more basic (or alkaline) in order to prevent blocking of the kidneys by haemoglobin fragments in the case of a massive breakdown of red blood cells (haemolysis).
What you need to know before you take it
e Sodium Bicarbonate 8.4% w/v You should not receive Sodium Bicarbonate 8.4% w/v
- if you are allergic to sodium bicarbonate or any of the other ingredients of this medicine (listed in section 6)
- if your blood is already too alkaline
- if your breath is slow or shallow or both (risk of worsening of excess acidic (=sour) substances in the blood)
- if your blood sodium level is abnormally high
- if your blood potassium level is abnormally low
- if you loose too much chloride Warnings and precautions Talk to your doctor before using Sodium Bicarbonate 8.4% w/v. Your doctor will take special care
- if your blood is too acidic because of breathing problems or lung problems
- if your blood calcium level is abnormally low
- if your blood has in total an abnormally high concentration of salts (hyperosmolarity)
- if you have any disease or condition where your sodium intake should be low, e.g. heart failure, fluid retention associated with swelling, high blood pressure, eclampsia (a condition associated with tissue swelling and convulsion during pregnancy) or kidney failure If breathing problems or lung problems are part of the reason why your blood is too acidic, care will be taken to help you breathe properly to get rid of the excess CO2 that is produced after administration of this medicine. Administration of this medicine may lead to sodium and fluid overload. Care will be taken to control your blood electrolyte levels, in particular potassium. Your fluid and acid-base balance will also be monitored. If necessary you will receive potassium and calcium supplements before you receive this medicine. It will be made sure that the cannula or small tube is correctly placed in a vein in order to avoid severe complications. The effects of sodium bicarbonate in some conditions leading to too much acidic substances in your blood, namely diabetic ketoacidosis, cardiac arrest or lactic acidosis, have not been investigated completely. If you suffer from these conditions, special care will be taken. Children Special care will be taken in newborns and children under 2 years, since a too rapid infusion of sodium bicarbonate solutions may lead to too much sodium in the blood, a decrease of the pressure in the brain fluid and (in preterm newborn infants) bleeding within the skull. Other medicines and Sodium Bicarbonate 8.4% w/v Tell your doctor if you are taking, have recently taken or might take any other medicines. Sodium bicarbonate may interact with other medicines, in particular
- corticosteroids, e.g. hydrocortisone, prednisone
- male sex hormones (androgens)
- medicines increasing the urine flow (diuretics), in particular those that promote potassium excretion.
Sodium bicarbonate promotes the excretion of acidic drug substances, e.g. acetylsalicylic acid, which may lead to a shortening or weakening of their effects. It may also delay the excretion of alkaline drug substances, which may make their effects longer lasting or stronger. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy If you are pregnant, you will receive this medicine only if your doctor considers it absolutely necessary for your recovery. Your doctor will exercise caution when administering this medicine to you if you suffer from pre-eclampsia, because the high sodium content of this medicine might be dangerous for you. Breast-feeding If you are breast-feeding, you will receive this medicine only if your doctor thinks that the benefits clearly outweigh the risks. Driving and using machines This medicine has no influence on the ability to drive and use machines.
How to take it
Sodium Bicarbonate 8.4% w/v This medicine will be given to you by a doctor or a nurse. You will be given this medicine by a drip via a small tube or cannula placed in a large vein. Your doctor will calculate the right dose of this medicine for you. He/she will also decide for how long the infusion should be given. This will depend on your clinical condition. For urine alkalinisation your dose is adjusted according to the desired degree of alkalinity and administration will be accompanied by careful monitoring of the acid-base balance, the water balance and the blood salt concentrations. If you received more Sodium Bicarbonate 8,4% w/v than you should Overdose may render your blood too alkaline or lead to an abnormally high blood sodium level or abnormally high salt levels in your blood. It can also lead to fluid excess. Too rapid infusion may be associated with an increased risk of brain damage resulting from an increased carbon dioxide load, especially when you have breathing problems. Treatment Your doctor will decide on further treatment and medication that you may need. If you have any further questions on the use of this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The possible side effects are listed according to their frequency. Not known (frequency cannot be estimated from the available data): Abnormally high blood sodium level, abnormally high blood salt levels. Administration of this medicine outside of a vein can cause tissue necrosis. Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
sodium bicarbonate Keep this medicine out of the sight and reach of children. To avoid formation of crystals, do not refrigerate or freeze. Do not store above 25 °C. Do not use this medicine after the expiry date which is stated on the bottle and the outer carton. The expiry date refers to the last day of that month. This medicine is an almost saturated solution and should therefore not be stored below normal room temperature. Crystals which may possibly have developed during storage can be dissolved by simply warming the bottle. Do not use this medicine if you notice
- cloudiness of the solution,
- particles in the solution,
- discolouration of the solution
- leaking of the bottle. Containers are for single use only. After use discard bottle and any unused content.
Contents of the pack and other information
What Sodium Bicarbonate 8.4% w/v contains •
The active substance is sodium bicarbonate. 1000 ml of the solution contain 84.0 g of sodium bicarbonate.
•
The other ingredients are disodium edetate and water for injections
What Sodium Bicarbonate 8.4% w/v looks like and contents of the pack Sodium Bicarbonate 8.4% w/v is a solution for infusion (administration as a vein drip). It is a clear, colourless, sterile solution of sodium bicarbonate in water. Theoretical osmolarity 2000 mOsm/l pH 7.0-8.5 It comes in colourless glass bottles sealed with rubber stoppers containing 100 ml, 250 ml and 500 ml supplied in packs of 1 x 100 ml, 10 x 100 ml, 20 x 100 ml 1 x 250 ml, 10 x 250 ml 1 x 500 ml, 10 x 500 ml Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer B. Braun Melsungen AG Carl-Braun-Str. 1 34212 Melsungen, Germany Postal address 34209 Melsungen, Germany Phone: +49-5661-71-0 Fax: +49-5661-71-45 67 This leaflet was last approved in March 2024.
Frequently asked questions about Sodium Bicarbonate 8.4% w/v solution for infusion
How do I take Sodium Bicarbonate 8.4% w/v solution for infusion?
Sodium Bicarbonate 8.4% w/v solution for infusion comes as infusion. 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 8.4% w/v solution for infusion?
The active substance in Sodium Bicarbonate 8.4% w/v solution for infusion is sodium bicarbonate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Sodium Bicarbonate 8.4% w/v solution for infusion, 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 8.4% w/v solution for infusion 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.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: sodium bicarbonate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
• Correction of metabolic acidosis;
• Urine alkalinisation:
- in the case of intoxication with weak organic acids, e. g. barbiturates or acetylsalicylic acid;
- in order to improve the solubility of drug substances that are poorly soluble in neutral or acid medium, e. g. methotrexate, sulphonamides;
- in the case of haemolysis.
4.2. Posology and method of administration
Posology
Correction of metabolic acidosis
Correction of metabolic acidosis should not be effected too rapidly. It is advisable to start administering only half of the calculated dose and adjust further doses according to the actual results of blood gas analysis.
The dose depends on the degree of the disorder of the acid-base status. According to the blood gas values the amount to be administered is calculated applying the following formula:
#mmol sodium bicarbonate = base deficit x kg body weight x 0.2
(The factor 0.2 corresponds to the proportion of the extracellular fluid in relation to total body weight).
Example:
If in a patient of 70 kg body weight the base deficit is 5 mmol/l, then 5 x 70 x 0.2 = 70 mmol of sodium bicarbonate (≜ 70 ml of Sodium Bicarbonate 8.4% w/v) are to be given.
Maximum daily dose:
According to the correction requirements.
Maximum infusion rate:
Up to 1.5 mmol of sodium bicarbonate per kg body weight per hour.
Paediatric population
The dosage has to be adjusted individually. The first dose can be up to 1 mmol/kg body weight, administered by slow intravenous infusion.
In newborns and children under 2 years: the daily dose should not exceed 5 mmol per kg body weight per day, administered by slow intravenous infusion. 4.2% w/v (or less concentrated) sodium bicarbonate solutions should be preferred (see also section 4.4).
Urine alkalinisation
For urine alkalinisation the dose is adjusted according to the desired pH of the urine and administration should be accompanied by monitoring of the acid-base balance, the water balance and the electrolyte balance. Care should be taken not to exceed the maximum infusion rate stated above. In haemodynamically stable adults and children urine alkalinisation may be achieved with a bolus of 1-2 mmol sodium bicarbonate per kg body weight, followed by an infusion of 132 mmol sodium bicarbonate in 1 litre of glucose 5% in water, with a flow rate of 1.5-2 times the maintenance fluid rate. Urine pH should not exceed 8.5.
Method of administration:
Intravenous use.
For central venous infusion only.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Respiratory and metabolic alkalosis
• Hypoventilation (risk of worsening acidosis)
• Hypernatraemia
• Hypokalaemia
• Excessive chloride loss
4.4. Special warnings and precautions for use
General
Sodium Bicarbonate should only be administered with particular caution in presence of the following conditions:
• respiratory acidosis
• hypocalcaemia
• increased serum osmolarity
• further in all situations where sodium intake must be restricted, like cardiac insufficiency, oedema, hypertension, eclampsia, severe kidney insufficiency.
When respiratory acidosis is concomitant with metabolic acidosis, both pulmonary ventilation and perfusion must be adequately supported to ensure adequate elimination of excess CO2.
Administration of Sodium Bicarbonate may lead to sodium and fluid overload.
Accidental paravenous administration may lead to tissue necrosis.
It must be made absolutely sure that the solution is infused intravenously; accidental intra-arterial infusion may cause shock or loss of an extremity.
If infused undiluted or too rapidly into peripheral veins, 8.4 % w/v Sodium Bicarbonate Intravenous Infusion may cause vein irritation and consecutively phlebitis or thrombosis on account of its alkalinity and its high osmolarity.
Patient monitoring should include regular checks of the acid-base balance, the serum electrolyte concentrations and the water balance.
Correction of the acid-base status is always associated with shifts of the electrolyte balance. In particular, the potassium balance is affected. Alkalinisation or correction of acidosis promote the potassium influx into cells and may therefore lead to hypokalaemia.
Potassium or calcium deficiencies should be corrected before beginning of the alkalinising therapy.
The effects of bicarbonate on organ function, complication rates and survival in diabetic ketoacidosis, cardiac arrest and lactic acidosis have not been investigated sufficiently. Caution is advised when using sodium bicarbonate in these conditions.
Paediatric population
Newborns and children under 2 years: rapid infusion (10 ml/min) of hypertonic sodium bicarbonate solutions may produce hypernatraemia, a decrease in cerebrospinal fluid pressure and (in preterm infants) possible intracranial haemorrhage. Therefore, do not administer > 5 mmol per kg body weight per day (see also section 4.2).
4.5. Interaction with other medicinal products and other forms of interaction
Urine alkalinisation by sodium bicarbonate accelerates the elimination of acidic drug substances, e.g. acetylsalicylic acid, and delays the elimination of basic drug substances.
Sodium bicarbonate may interact with gluco- and mineralocorticoids, androgens and diuretics increasing the potassium excretion.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of sodium bicarbonate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Sodium Bicarbonate should not be used during pregnancy unless the clinical condition of the woman requires treatment with sodium bicarbonate. Bicarbonate readily crosses the placental barrier.
Caution should be exercised in pre-eclampsia due to the high sodium level of the medicinal product (see section 4.4).
Breast-feeding
It is unknown whether sodium bicarbonate/metabolites are excreted in human milk. During breast-feeding the solution should only be given if the benefits clearly outweigh the risks.
Fertility
No data available.
4.7. Effects on ability to drive and use machines
Sodium Bicarbonate has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Listing of undesirable effects
Undesirable effects are listed according to their frequencies as follows:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:
≥ 1/10
≥ 1/100 to < 1/10
≥ 1/1,000 to < 1/100
≥ 1/10,000 to < 1/1,000
<1/10,000
Frequency cannot be estimated from the available data
Metabolism and nutrition disorders
Not known: Hypernatraemia, serum hyperosmolarity
Paravenous administration may lead to tissue necrosis (see also section 4.4).
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.
4.9. Overdose
Symptoms
Overdose may lead to alkalosis, hypernatraemia, serum hyperosmolarity or hyperhydration. When an acidosis is corrected too rapidly, esp. in the presence of respiratory disorders, the increased liberation of carbon dioxide may transiently aggravate cerebral acidosis.
Treatment
Therapy of alkalosis, depending on its severity: Infusion of physiological saline, substitution of potassium; in marked alkalosis infusion of arginine hydrochloride or hydrochloric acid.
In general the patient should be treated symptomatically and electrolytes and acid-base balance should be monitored.
💬 Ask about this leaflet
Ask anything about Sodium Bicarbonate 8.4% w/v solution for infusion. 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.