Consumer medicine information

Sodium Bicarbonate (Pfizer)

Sodium bicarbonate

BRAND INFORMATION

Brand name

Pfizer (Perth) Sodium Bicarbonate 8.4% Injection BP

Active ingredient

Sodium bicarbonate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sodium Bicarbonate (Pfizer).

What is in this leaflet

This leaflet answers some common questions about Sodium Bicarbonate Intravenous Infusion. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you being given Sodium Bicarbonate Intravenous Infusion against the benefits they expect it to have for you.

This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What SODIUM BICARBONATE INTRAVENOUS INFUSION is used for

Sodium Bicarbonate Intravenous Infusion is given to patients who have too much acid, or who have not enough sodium or bicarbonate in their blood. This chemical is naturally present in body fluids and is needed for normal body function.

Sodium Bicarbonate Intravenous Infusion may be used for the treatment of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been given Sodium Bicarbonate Intravenous Infusion.

Ask your doctor if you have any questions about why it has been given to you.

Before you are treated with SODIUM BICARBONATE INTRAVENOUS INFUSION

When you must not take it

You should not be given Sodium Bicarbonate Intravenous Infusion if you have an allergy to:

  • any medicine containing sodium bicarbonate
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Sodium Bicarbonate Intravenous Infusion should not be given if you have or have had any of the following medical conditions:

  • kidney problems including kidney stones
  • high blood pressure
  • heart disease
  • any swelling of the face or limbs
  • low levels of potassium in the blood
  • low levels of chloride in the blood
  • shortness of breath
  • high blood pressure or other illness due to pregnancy.

Check with your doctor if you are unsure whether these conditions apply to you.

Your doctor or nurse will check that the Sodium Bicarbonate Intravenous Infusion is not cloudy when added to other intravenous solutions. Your doctor or nurse will also check that it is not past its use by date nor has it been tampered with.

If you are not sure whether you should be given this medicine talk to your doctor.

Before you start to be given it

You must tell your doctor if:

  1. you have any allergies to:
  • any other medicine
  • any other substances, such as foods, preservatives or dyes.
  1. you are pregnant or intend to become pregnant
your doctor will discuss the possible risks and benefit of being given Sodium Bicarbonate Intravenous Infusion during pregnancy.
  1. you are breast feeding or plan to breast feed
It is not known whether sodium bicarbonate passes into breast milk, however there have been no problems reported in breast fed infants.
  1. Tell your doctor if you have or have had any of the following medical conditions:
  • liver disease
  • nausea or vomiting
  • abdominal pain
  • tiredness
  • severe anaemia
  • hypotension
  • irregular heart rate
  • diabetes.

If you have not told your doctor about any of the above, tell him/her before you are started on this medicine.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may affect the way sodium bicarbonate works. These include:

  • some antibiotics such as tetracyclines, doxycycline and penicillin
  • some decongestants such as ephedrine and pseudoephedrine
  • medicines for heart problem such as quinidine, isoprenaline, flecainide and adrenaline
  • anti-inflammatory agents such as salicylates, aspirin, corticosteroids and corticotrophin
  • stimulants such as amphetamines, lithium, tricyclic and barbiturates
  • diuretics such as bumetanide, ethacrynic acid, frusemide and thiazides
  • stomach ulcer treatment such as glycopyrrolate
  • cancer treatment such as carmustine
  • medicine used in anaesthesia such as suxamethonium chloride.

If you are unsure whether you are taking any of the above medicines, ask your doctor or pharmacist. These medicines may be affected by sodium bicarbonate or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How SODIUM BICARBONATE INTRAVENOUS INFUSION is given

How it is given

Sodium Bicarbonate Intravenous Infusion treatment usually occurs in a hospital. It will be given to you as a slow injection into one of your veins (this is called an intravenous infusion) by your doctor or a specially trained nurse.

How much is given

Your doctor will decide what dose, how often and how long you will receive it. This depends on your condition and other factors, such as your weight, age, blood tests, how well your kidneys are working, and whether or not other medicines are being given at the same time.

Follow all directions given to you by your doctor and pharmacist carefully. These directions may differ from the information contained in this leaflet.

Never administer this medicine yourself.

If you are given too much (overdose)

This rarely happens as Sodium Bicarbonate Intravenous Infusion is administered under the care of a highly trained doctor or nurse.

However, if you are given too much sodium bicarbonate you may experience some of the effects listed under "Side Effects" below.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Sodium Bicarbonate Intravenous Infusion. Like other medicines, sodium bicarbonate can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.

Ask your doctor or nurse to answer any questions that you may have. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or nurse as soon as possible if you notice any of the following:

  • twitching or cramps particularly of the muscles in the face, hands or feet
  • restlessness or irritability
  • peeling skin at the site of injection
  • sleepiness or confusion
  • shortness of breath
  • muscle weakness
  • nausea or vomiting.

These are the more common side effects of sodium bicarbonate. Mostly these are mild and short-lived.

Tell your doctor immediately if you notice any of the following:

  • signs of allergy such as a rash, itching, hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Some side effects may only be seen by your doctor.

After using SODIUM BICARBONATE INTRAVENOUS INFUSION

Storage

Sodium Bicarbonate Intravenous Infusion is stored in the pharmacy or on the ward. The medicine is kept in a cool dry place, where the temperature stays below 30°C.

Product Description

What it looks like

Sodium Bicarbonate Intravenous Infusion is a clear, colourless solution contained in a 100mL glass vial.

Ingredients

Sodium Bicarbonate Intravenous Infusion contains sodium bicarbonate and disodium edetate in sterile water. It does not contain a preservative.

Manufacturer

Pfizer (Perth) Pty Limited
ABN 32 051 824 956
15 Brodie Hall Drive,
Bentley WA 6102 Australia

Supplier

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free number: 1800 675 229

Australian Registration Numbers

AUST R 10801 - Sodium Bicarbonate 8.4% (8.4g/100mL) injection BP vial

Date of preparation

March 2020

© Pfizer Australia Pty Ltd

Published by MIMS May 2020

BRAND INFORMATION

Brand name

Pfizer (Perth) Sodium Bicarbonate 8.4% Injection BP

Active ingredient

Sodium bicarbonate

Schedule

Unscheduled

 

1 Name of Medicine

Sodium bicarbonate.

2 Qualitative and Quantitative Composition

A sterile, hypertonic, preservative-free solution containing sodium bicarbonate 8.4 g/100 mL.
Each mL of solution contains 1 mmol each of sodium and bicarbonate ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection for intravenous infusion.
A clear, colourless solution, free from visible impurities.

4 Clinical Particulars

4.1 Therapeutic Indications

Metabolic acidosis in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis where a rapid increase in plasma total CO2 content is crucial. Treatment of metabolic acidosis should be concurrent with measures designed to control the cause of the acidosis.
Urinary alkalinisation in the treatment of certain drug intoxications (i.e. barbiturates, salicylates, lithium, methyl alcohol) and in the haemolytic reactions requiring alkalinisation of the urine to diminish nephrotoxicity of blood pigments.
Urinary alkalinisation is also used in methotrexate therapy to prevent nephrotoxicity.
Severe diarrhoea which is often accompanied by a significant loss of bicarbonate.

4.2 Dose and Method of Administration

Dosage.

In cardiac arrest.

Administration is determined based on the results of arterial blood pH, PaCO2 and calculation of base deficit. For adults, an initial dose of 1 mmol/kg followed by 0.5 mmol/kg every 10 minutes of arrest, depending on arterial blood gases. In cardiac arrest, the risks from acidosis exceed those of hypernatraemia.

In mild conditions of metabolic acidosis.

Sodium bicarbonate intravenous infusion may be admixed with other intravenous fluids if compatibility is proven.
The amount of bicarbonate to be given to older children and adults over a 4 to 8 hour period is approximately 2 to 5 mmol/kg, depending upon the severity of the acidosis as judged by the lowering of total CO2 content, blood pH and clinical condition of the patient. Initially, an infusion of 2 to 5 mmol/kg over 4 to 8 hours will produce improvement in the acid-base status of the blood.
Therapy should be planned in a step by step method as the degree of response from a given dose is not precisely predictable.
In general it is unwise to try and fully correct a low total CO2 content during the first 24 hours of therapy. This may be accompanied by unrecognised alkalosis due to a delay in the readjustment of normal ventilation.

Children and adolescents.

Children.

The usual dose is 1 mmol/kg (1 mL/kg) given by slow intravenous injection.

For infants up to 2 years of age.

A 4.2% solution is recommended at a rate not exceeding 8 mmol/kg/day. This will minimise the risk of the possibility of hypernatraemia, decreasing cerebrospinal fluid pressure and intracranial haemorrhage. Diluents may be sterile physiological solution, glucose 5%, or other standard electrolyte solutions but each should be tested for compatibility.

Method of administration.

Sodium bicarbonate intravenous infusion is administered intravenously preferably into a large vein.

4.3 Contraindications

Renal failure.
Metabolic alkalosis.
Respiratory alkalosis.
Hypertension.
Oedema.
Congestive heart failure.
A history of urinary calculi and coexistent potassium depletion or hypocalcaemia.
Hypernatraemia, hypoventilation or chloride depletion.
In patients at risk of developing diuretic induced hypochloraemic alkalosis.
Eclampsia, aldosteronism.
It is also generally contraindicated in patients with excessive chloride loss from vomiting or continuous gastrointestinal suctioning and in patients at risk of developing diuretic induced hypochloraemic alkalosis.

4.4 Special Warnings and Precautions for Use

Whenever respiratory acidosis is concomitant with metabolic acidosis, both pulmonary ventilation and perfusion must be adequately supported to get rid of excess carbon dioxide.
To minimise the risks of pre-existing hypokalaemia and/or hypocalcaemia, these electrolyte disturbances should be corrected prior to initiation of, or concomitantly with, sodium bicarbonate therapy.
Arterial blood gas analysis, in particular, arterial/venous blood pH and carbon dioxide levels should be performed during the course of sodium bicarbonate treatment to minimise the possibility of overdosage and resultant alkalosis.
Accidental extravasation of hypertonic solutions may cause cellulitis, tissue necrosis, ulceration, vascular irritation and sloughing. The use of scalp veins should be avoided. Prompt elevation of the affected area, warmth and local injection of lignocaine or hyaluronidase are recommended to prevent sloughing.
Whenever respiratory acidosis is present with metabolic acidosis both pulmonary ventilation and perfusion must be adequately supported in order to eliminate excess CO2.
Solutions containing sodium may cause fluid and/or solute overload, resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary oedema. Extravascular infiltration should be avoided (see Section 4.8 Adverse Effects (Undesirable Effects)).
Sodium bicarbonate should be used with caution in patients with cirrhosis.
Excessively elevated plasma sodium concentrations may cause dehydration of the brain, resulting in somnolence and confusion, which may progress to convulsions, coma, respiratory failure and ultimately death.
Bicarbonate should be given with caution to patients with type A lactic acidosis (tissue hypoxia). Administration of bicarbonate may limit the available oxygen, increase lactate production, thus, worsen the acidosis.
Sodium bicarbonate should not be used in the treatment of diabetic ketoacidosis with pH between 6.90 and 7.10.
Do not use the injection if it contains precipitate. Do not use unless the solution is clear and the container and seal are intact. Discard any unused portion.
The aim of all bicarbonate therapy is to produce a substantial correction of the low total CO2 content and blood pH, but the risks of overdosage and alkalosis should be avoided. Hence, repeated fractional doses and periodic monitoring by appropriate laboratory tests are recommended to minimise the possibility of overdosage.

Use in renal impairment.

Sodium retention and oedema may occur during sodium bicarbonate therapy, especially when the drug is given in large doses or to patients with renal insufficiency, congestive heart failure or those predisposed to sodium retention and oedema. Sodium and water overload may result in hypernatraemia and hyperosmolality. Severe hyperosmolal states may develop during cardiopulmonary resuscitation when excessive doses of sodium bicarbonate are administered. Serum potassium may decrease during sodium bicarbonate therapy leading to hypokalaemia.
Sodium bicarbonate should be used with extreme caution in patients with renal insufficiency or other oedematous or sodium retaining conditions; especially those with severe insufficiency such as oliguria or anuria; and in patients receiving corticosteroids or corticotropin, since each gram of sodium bicarbonate contains 12 mEq of sodium.

Use in the elderly.

Clinical studies of sodium bicarbonate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

Paediatric use.

Rapid injections (10 mL/min) of hypertonic sodium bicarbonate solutions to neonates and children under 2 years of age may produce hypernatraemia, a decrease in cerebrospinal fluid pressure and possible intracranial haemorrhage. Do not administer more than 8 mmol/kg/day.
In emergency situations, such as cardiac arrest, the risk of rapid infusion of the drug must be weighed against the potential for death from acidosis. Also, administration of this drug to children undergoing cardiopulmonary resuscitation may worsen respiratory acidosis.

Effects on laboratory tests.

The high urinary alkalinity sometimes produced by sodium bicarbonate may cause a false positive Labistix test for urinary protein.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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.
The addition of sodium bicarbonate to solutions containing calcium should be avoided except where compatibility has been shown. Solutions turning hazy as a result of sodium bicarbonate-calcium admixtures should be discarded.
Use caution when giving parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotrophin.
Hypochloraemic alkalosis may occur if sodium bicarbonate is used in conjunction with potassium depleting diuretics such as bumetanide, ethacrynic acid, frusemide and thiazides. Concurrent use in patients taking potassium supplements may reduce serum potassium concentration by promoting an intracellular ion shift. Potassium depletion may predispose to metabolic alkalosis and coexistent hypocalcaemia may be associated with carpopedal spasm as the plasma pH rises. These dangers can be minimised if such electrolyte imbalances are appropriately treated prior to or concomitantly with bicarbonate infusion.
Alkalinisation of the urine leads to increased renal clearance of acidic drugs such as salicylates, tetracyclines (especially doxycycline), barbiturates and tricyclic antidepressants. Conversely, it prolongs the half-life and duration of basic drugs such as quinidine, amphetamines, ephedrine and pseudoephedrine and may result in toxicity.
Sodium bicarbonate enhances lithium excretion.
Solutions containing sodium ions should be used with great care, if at all, in patients receiving corticosteroids or corticotropin.
The following drug may have enhanced or prolonged effects due to concomitant administration with sodium bicarbonate: flecainide.
The following drugs may have decreased effectiveness due to concomitant administration with sodium bicarbonate: aspirin and other salicylates, barbiturates and lithium.
The following drugs have been reported to be susceptible to inactivation on mixing with sodium bicarbonate solution: adrenaline HCl, benzylpenicillin potassium, carmustine, glycopyrrolate, isoprenaline HCl and suxamethonium chloride.
Additives may be incompatible with the product; noradrenaline (norepinephrine) and dobutamine are incompatible with sodium bicarbonate solution. When introducing additives, use aseptic technique, mix thoroughly and do not store the resultant solution.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
Animal reproduction studies have not been performed with sodium bicarbonate. It is also not known whether sodium bicarbonate can cause foetal harm when administered to pregnant women. Sodium bicarbonate should be used during pregnancy only when clearly needed and the benefits of therapy outweigh the potential risks.
 It is not known whether sodium bicarbonate is excreted in breast milk. However, problems in humans have not been reported.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Alkalosis and/or hypokalaemia may result from prolonged use or overcorrection of the bicarbonate deficit, especially in patients with impaired renal function (see Section 4.9 Overdose).
Hyperirritability or tetany may occur caused by rapid shifts of free ionised calcium or due to serum protein alterations arising from the pH changes. Metabolic alkalosis may be accompanied by compensatory hyperventilation, paradoxical acidosis of the cerebrospinal fluid, severe hypokalaemia, hyperirritability or tetany.
Hypernatraemia has been reported with sodium bicarbonate use, especially in patients with renal disease.
Hyperosmolality has also been associated with sodium bicarbonate use.
Accidental extravasation of intravenous hypertonic solutions of sodium bicarbonate has been reported to cause chemical cellulitis, with tissue necrosis, tissue calcification, ulceration or sloughing at the site of infiltration. Hyperirritability or tetany may occur, caused by rapid shifts of free ionised calcium or due to serum protein alterations arising from the pH changes.
Cerebral oedema has occurred with sodium bicarbonate use and a possibility of intracranial haemorrhage exists.
Hypercapnia has occurred in patients receiving sodium bicarbonate and with fixed ventilation.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

Alkalosis is a direct result of overdosage. Excessive administration of bicarbonate may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Symptoms include mood changes (hyperirritability), tiredness, shortness of breath, muscle weakness and irregular heartbeat. Muscle hypertonicity, twitching and tetany may develop, especially in hypocalcaemic patients.

Treatment.

Administration of sodium bicarbonate should be immediately discontinued. In order to control the symptoms of alkalosis, the patient should rebreathe expired air, and the patient treated with intravenous sodium chloride 0.9% and potassium chloride if hypokalaemia is present.
Any accompanying hyperirritability or tetany can be controlled with calcium gluconate. Ammonium chloride may be indicated in severe cases (except in patients with pre-existing hepatic disease).
Treatment of hypernatraemia usually requires water replacement. In some cases, restricted sodium intake and oral water may be sufficient. If more severe, glucose 5% may be administered by slow intravenous infusion. If total body sodium is too high, loop diuretics combined with an infusion of 5% glucose and potassium supplementation may be necessary.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Sodium bicarbonate is a systemic alkalising agent which, when given intravenously, will increase plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Sodium bicarbonate dissociates in water to provide sodium (Na+) and bicarbonate (HCO-3) ions. Sodium is the principal cation of the extracellular fluid. Bicarbonate is a normal constituent of body fluids and the normal plasma level ranges from 24 to 31 mmol/L. Plasma concentration is regulated by the kidney. The bicarbonate anion, at the correct concentration of hydrogen ion (H+) may be converted to carbonic acid (H2CO3), then to its volatile form, carbon dioxide (CO2) which is excreted by the lung. Normally, a ratio of 1:20 (carbonic acid: bicarbonate) is present in the extracellular fluid.

Excretion.

In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed and less than 1% is excreted in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Disodium edetate, water for injections.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Single use only. Discard any unused portion.

6.5 Nature and Contents of Container

A 100 mL glass vial with a grey halobutyl siliconised rubber stopper. Each carton contains 10 vials.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


Molecular Formula: NaHCO3.

CAS number.

144-55-8.

7 Medicine Schedule (Poisons Standard)

Australia - Unscheduled.

Summary Table of Changes