Consumer medicine information

DBL Sodium Acetate Concentrated Injection [8165]

Sodium acetate

BRAND INFORMATION

Brand name

DBL Sodium Acetate Concentrated Injection

Active ingredient

Sodium acetate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using DBL Sodium Acetate Concentrated Injection [8165].

What is in this leaflet

This leaflet answers some common questions about DBL™ Sodium Acetate Concentrated Injection.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you being given sodium acetate against the benefits they expect it will have for you.

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

Keep this leaflet in a safe place.

You may need to read it again.

What DBL™ Sodium Acetate Concentrated Injection is used for

Sodium acetate can be added to total parenteral nutrition (TPN) solutions as a source of sodium and acetate ions, or to increase the pH of the solution.

Sodium acetate can also be used to treat low blood sodium (hyponatraemia).

Your doctor may have prescribed sodium acetate for another reason. Ask your doctor if you have any questions about why sodium acetate has been prescribed for you.

DBL™ Sodium Acetate Concentrated Injection is not addictive.

Before you are given DBL™ Sodium Acetate Concentrated Injection

When you must not be given it

You should not be given DBL™ Sodium Acetate Concentrated Injection if you have an allergy to sodium acetate.

Symptoms of an allergic reaction to sodium acetate 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.

You should not be given DBL™ Sodium Acetate Concentrated Injection if you have any of the following conditions:

  • high blood sodium
  • fluid retention
  • severe kidney disease
  • severe burns
  • severe or prolonged diarrhoea or vomiting
  • uncontrolled diabetes mellitus
  • high blood pH
  • low blood calcium
  • low blood chloride
  • low blood potassium.

If you are not sure whether you should be given DBL™ Sodium Acetate Concentrated Injection, talk to your doctor or pharmacist.

Before you are given it

Tell your doctor or pharmacist if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.

Your doctor or pharmacist will discuss the possible risks and benefits of being given sodium acetate during pregnancy.

Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed.

Your doctor or pharmacist will discuss the possible risks and benefits of being given sodium acetate during breast-feeding.

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:

  • heart failure
  • fluid retention or oedema
  • kidney disease
  • liver disease
  • high blood pressure
  • low or no urine production.

If you have not told your doctor or pharmacist about any of the above, tell them before you are given sodium acetate.

Taking other medicines

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

Some medicines and sodium acetate may interfere with each other. These include:

  • corticosteroids or corticotrophin
  • pain killers such as aspirin
  • barbiturates, medicines used to treat epilepsy
  • antibiotics, medicines used to treat infections, particularly doxycycline
  • quinidine, a medicine used to control heart rhythm
  • ephedrine or pseudoephedrine
  • lithium, a medicine used to treat some psychiatric disorders
  • diuretics (fluid tablets), such as bumetanide, ethacrynic acid, frusemide or thiazide diuretics
  • potassium supplements.

These medicines may be affected by sodium acetate, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while being given sodium acetate.

How DBL™ Sodium Acetate Concentrated Injection is given

How it is given

Sodium acetate should only be used under the supervision of your doctor. It is usually given as an intravenous injection or an infusion (ie. a slow injection through a 'drip' into the vein).

How much is given

Your doctor will decide what dose will receive. This depends on your condition and other factors, such as your weight.

If you take too much (overdose)

As sodium acetate is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

If you think that you or anyone else may have been given too much DBL™ Sodium Acetate Concentrated Injection tell your doctor immediately or go to the Accident and Emergency department of your nearest hospital or immediately contact the Poisons Information Centre for advice on management. (In Australia, call 13 11 26; in New Zealand call 0800 764 766). Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of a sodium acetate overdose include the side effects listed in the 'Side effects' section, but are usually of a more severe nature.

While you are being given DBL™ Sodium Acetate Concentrated Injection

Things you must do

Tell your doctor, nurse or pharmacist if you have any concerns before, during or after administration of sodium acetate.

Tell any other doctors, dentists, and pharmacists who are treating you that you are being given sodium acetate.

If you are about to be started on any new medicine, tell your doctor or pharmacist that you are being given sodium acetate.

If you plan to have surgery that needs a general anaesthetic, tell your doctor that you are being given sodium acetate.

If you become pregnant after being given sodium acetate, tell your doctor or pharmacist.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

It may interfere with the results of some tests.

Things to be careful of

Be careful driving or operating machinery until you know how DBL™ Sodium Acetate Concentrated Injection affects you.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given sodium acetate.

Sodium acetate helps most people with low blood sodium levels, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • thirst
  • dry mouth or eyes
  • fever
  • fast or irregular heart rate
  • headache
  • dizziness
  • restlessness
  • weakness
  • mood changes
  • muscle weakness or twitching
  • pain at the infusion site.

These are the more common side effects of sodium acetate.

Tell your doctor or pharmacist immediately if you notice the following:

  • sleepiness or confusion
  • convulsions
  • difficulty breathing.

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After being given DBL™ Sodium Acetate Concentrated Injection

Storage

DBL™ Sodium Acetate Concentrated Injection will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays below 30°C.

Product description

What it looks like

DBL™ Sodium Acetate Concentrated Injection is a clear, colourless solution.

Ingredients

Active ingredients:

  • sodium acetate

Other ingredients

  • water for injections.

DBL™ Sodium Acetate Concentrated Injection does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Australian Sponsor:

Hospira Australia Pty Ltd
ABN 58 097 064 330
Level 3
500 Collins Street
Melbourne VIC 3000
Australia

New Zealand Sponsor:

Hospira NZ Limited
23 Haining Street
Te Aro, Wellington
New Zealand

DBL™ Sodium Acetate Concentrated Injection is available in the following strength and pack size:

  • 1.64 grams in 10mL ampoule (20mmol/10mL)
    AUST R 16262

This leaflet was updated in November 2011.

BRAND INFORMATION

Brand name

DBL Sodium Acetate Concentrated Injection

Active ingredient

Sodium acetate

Schedule

Unscheduled

 

1 Name of Medicine

Sodium acetate.

6.7 Physicochemical Properties

The chemical formula of sodium acetate trihydrate is CH3COONa.3H2O. Its molecular weight is 136.1.

Chemical structure.

No data available.

CAS number.

The CAS Registry number is 6131-90-4.

2 Qualitative and Quantitative Composition

DBL Sodium Acetate Concentrated Injection contains 272.16 milligrams of sodium acetate (trihydrate) in each mL of water for injections. This is equivalent to 164 milligrams of sodium acetate (anhydrous) or 46 milligrams of sodium in each mL. DBL Sodium Acetate Concentrated Injection contains 2 mEq (2 mmol) of sodium ions, and 2 mEq (2 mmol) of acetate ions in each 1 mL. The strength supplied is 1.64 grams/10 mL in a glass ampoule.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sodium acetate trihydrate is a white granular crystalline powder, or white flakes or colourless transparent crystals. It is odourless, or has a slight odour of acetic acid.
DBL Sodium Acetate Concentrated Injection is a clear, colourless solution. The pH of the solution ranges between 8.2 and 9.2.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Sodium is the principal cation in the extracellular fluid, comprising more than 90% of total cations at its normal plasma concentration (between 135 to 145 mmol/L). Potassium ions predominate in the intracellular fluid. A membrane bound enzyme, sodium-potassium-activated adenosine triphosphatase (Na+-K+-ATPase), actively transports or pumps sodium out of, and potassium into, cells to maintain this concentration gradient.
Sodium has a primary role in regulating extracellular fluid volume. It controls water distribution, fluid and electrolyte balance and the osmotic pressure of body fluids. Sodium is also involved in nerve conduction, muscle contraction, acid-base balance and cell nutrient uptake.
Sodium homoeostasis is complex, and is closely associated with fluid balance. Small changes in plasma sodium concentrations are corrected by alterations to the extracellular fluid volume. The secretion or suppression of antidiuretic hormone (ADH) primarily controls water excretion by the kidney. Higher plasma sodium levels suppress ADH secretion and promote renal water loss, while an increase in ADH secretion increases water reabsorption by the renal distal tubules. Changes in extracellular volume will also affect ADH release, independently of osmolality. In addition, changes in extracellular volume modulate renal sodium excretion.
Total body sodium content is regulated by renal sodium excretion. Mechanisms involved include the renin angiotensin system, glomerular filtration rate and natriuretic factors. A reduction in extracellular fluid volume leads to the production of angiotensin II, which stimulates aldosterone secretion. Aldosterone promotes sodium ion reabsorption by the distal tubules. Adrenal insufficiency or mineralocorticoid excess may disturb this mechanism.
Sodium acetate is metabolised in the liver to the bicarbonate. This has been shown to proceed readily, even in the presence of severe liver disease. Sodium acetate and other bicarbonate precursors are alkalinising agents and can be used to correct metabolic acidosis, or for alkalinisation of the urine. Sodium acetate can be used to increase plasma bicarbonate concentration, help restore the plasma pH to within the normal range (7.37 - 7.42) and correct potassium imbalances in cases of acidosis. It can also be used to increase urinary pH in subjects with normal renal function. This can increase the solubility of certain weak acids, and can increase the ionisation and excretion of lipid soluble organic acids, such as phenobarbitone and salicylates.
In the absence of a plasma bicarbonate deficit, bicarbonate ions are excreted in the urine, making the urine alkaline. This is accompanied by diuresis.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Following administration, the acetate ion is metabolised in the liver to bicarbonate. Both the sodium and bicarbonate ions are excreted mainly in the urine. Some sodium is excreted in the faeces and small amounts may also be excreted in saliva, sweat, bile and pancreatic secretions.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No information is available on the carcinogenicity or mutagenicity of sodium acetate.

4 Clinical Particulars

4.1 Therapeutic Indications

DBL Sodium Acetate Concentrated Injection is indicated for inclusion in total parenteral nutrition (TPN) solutions as an electrolyte source. Sodium acetate may also be added to parenteral solutions to increase pH.
DBL Sodium Acetate Concentrated Injection may also be used for the treatment of hyponatraemia (sodium depletion) states, in cases where oral sodium therapy is contraindicated or not tolerated.

4.3 Contraindications

Sodium acetate concentrated injection is contraindicated in patients who are hypersensitive to sodium or acetate. It should not be administered to patients with hypernatraemia, fluid retention or severe renal impairment.
Sodium acetate concentrated injection should not be administered to patients suffering from conditions which are likely to lead to dehydration (e.g. severe burns, severe or prolonged diarrhoea or vomiting, or uncontrolled diabetes mellitus).
Sodium acetate forms the bicarbonate after metabolism; therefore, sodium acetate should not be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia, chloride depletion or hypokalaemia.

4.4 Special Warnings and Precautions for Use

Sodium acetate concentrated injection must be diluted with a compatible infusion fluid prior to administration.
Diluted solutions of sodium acetate must be administered slowly, as rapid intravenous injection of sodium may lead to hypernatraemia and fluid overload. Hypernatraemia is more likely to occur if sodium acetate is administered intravenously to patients with impaired mechanisms for excreting sodium (e.g. chronic renal disease). Potentially fatal hypernatraemia can develop rapidly and asymptomatically. Therefore, careful monitoring of serum sodium concentration and appropriate dosage adjustment is recommended.
Elevated plasma sodium concentration may cause dehydration of the brain, which can result in somnolence and confusion, progressing to convulsions, coma, respiratory failure and death.
Sodium acetate should be used with extreme caution in patients with congestive heart failure, other oedematous states, renal function impairment, cirrhosis, eclampsia, hypertension or aldosteronism. It should also be used with caution in patients with oliguria or anuria.
Solutions containing sodium ions should be administered cautiously to patients receiving corticosteroids or corticotropin.
Acetate should be administered with caution in those conditions where there is an increased level or impaired utilisation of the acetate ion, such as severe hepatic impairment.

Use in renal impairment.

Sodium acetate should be used with extreme caution in patients with renal function impairment.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Alkalinisation of the urine by sodium acetate may cause a false positive Labstix test for urinary protein.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Alkalinisation of the urine by sodium acetate may increase the renal clearance of acidic drugs, such as salicylates, barbiturates and tetracyclines, especially doxycycline.
Urinary alkalinisation may decrease the renal clearance of basic drugs, such as quinidine, amphetamines, ephedrine, pseudoephedrine and lithium, and may result in toxicity.
Hypochloraemic alkalosis may occur if sodium acetate 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 levels by promoting an intracellular ion shift.
Solutions containing sodium ions should be administered with caution to patients receiving corticosteroids or corticotropin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
Sodium is a natural constituent of human tissues and fluids. Since high levels of sodium may lead to dehydration, serum levels should be closely monitored in pregnant women being treated with sodium salts. Serum potassium levels and pH should also be closely monitored, as the acetate ion may cause hypokalaemia or metabolic alkalosis.
Sodium acetate concentrated injection should only be used in pregnant women if the expected benefits outweigh the possible risks to the mother or foetus.
Sodium is likely to be excreted into breast milk. Sodium acetate concentrated injection should only be used in women who are breastfeeding if the expected benefits to the mother outweigh the possible risks to the infant.

4.8 Adverse Effects (Undesirable Effects)

Excessive doses of sodium salts may lead to hypernatraemia. The most serious effect of hypernatraemia is dehydration of the brain, which causes somnolence and confusion, progressing to convulsions, coma, respiratory failure and death. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, irritability and weakness.
Excessive administration of compounds which are metabolised to form the bicarbonate anion (such as acetate) may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Symptoms may include mood changes, tiredness, shortness of breath, muscle weakness and irregular heartbeat. Hyperirritability, muscle hypertonicity, twitching and tetany may develop, especially in hypocalcaemic patients. These may occur as a result of rapid shifts of free ionised calcium, or serum protein alterations arising from the pH changes.
Extravasation of hypertonic solutions containing sodium acetate may result in chemical cellulitis and ulceration.

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.

4.2 Dose and Method of Administration

DBL Sodium Acetate Concentrated Injection must be diluted with a suitable infusion solution prior to administration.
Each mL of DBL Sodium Acetate Concentrated Injection contains 2 mEq (2 mmol) of sodium ions and 2 mEq (2 mmol) of acetate ions.

1. Use in total parenteral nutrition (TPN) solutions or other parenteral solutions.

The desired quantity of DBL Sodium Acetate Concentrated Injection should be added to the TPN or other solution. Serum sodium levels should be monitored as a guide to dosage.

2. Treatment of hyponatraemia (sodium depletion).

The concentration and dosage of sodium solutions for intravenous use is determined by several factors including the age, weight and clinical condition of the patient and in particular the patient's hydration state. Serum electrolyte concentrations and total body water should be carefully monitored throughout. Hypernatraemia should not be allowed to develop.
Therapy should be guided by the rate and degree of development of hyponatraemia. Volume depletion should also be corrected where necessary.

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.

4.9 Overdose

Symptoms.

Excessive administration or impaired excretion of sodium leads to the development of potentially fatal hypernatraemia, while excessive administration of the acetate may lead to hypokalaemia and metabolic alkalosis (see Section 4.8 Adverse Effects (Undesirable Effects)).

Treatment.

Serum sodium concentrations should be measured and if severe hypernatraemia is present, this should be treated. Treatment of hypernatraemia usually requires water replacement. In some cases, oral administration of water and restriction of sodium intake may be sufficient. In more severe cases, glucose 5% may be administered by slow intravenous infusion.
If the total body sodium content is too high, loop diuretics may be used to increase sodium excretion, with fluid losses being replaced by an infusion of glucose 5% and potassium chloride. Dialysis may be necessary if there is significant renal impairment, if the patient is moribund, or if the serum sodium concentration is greater than 200 mmol/L.
If alkalosis occurs, administration of the acetate should be stopped and the patient managed according to the degree of alkalosis present. Rebreathing expired air may help control the symptoms of alkalosis. Sodium chloride 0.9% may be administered intravenously. Calcium gluconate may be necessary to control the hyperirritability and tetany which may occur with more severe alkalosis. Ammonium chloride could be administered intravenously in cases of severe alkalosis, except in patients with pre-existing hepatic disease. Potassium chloride should be administered if hypokalaemia is present.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia). In New Zealand call 0800 764 766.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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.

6.5 Nature and Contents of Container

DBL Sodium Acetate Concentrated Injection is supplied in glass ampoules as follows:
Strength: 1.64 grams/10 mL (cartons contain 10 and 50 ampoules).
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

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

Summary Table of Changes