Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Glucose 50%. It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Glucose 50% against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet in a safe place. You may need to read it again.

What Glucose 50% is used for

Glucose is a sugar which provides energy for the body.

Glucose 50% is used to treat low blood sugar levels. It may also be:

• added to intravenous solutions as a source of calories for patients unable to consume food.
• used to treat pressure on the brain and spinal chord and/or swelling of the body caused from consuming too much alcohol.

Ask your doctor if you have any questions about why Glucose 50% has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you are given Glucose 50%

When you must not be given it

You should not be given Glucose 50% if you have an allergy to:

• any medicine containing glucose
• any medicine listed at the end of this leaflet
• corn (maize) and corn products.

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.

Glucose 50% should not be given if you have any of the following medical conditions:

• very high blood sugar levels
• difficulty digesting sugars
• unable to pass urine
• bleeding in the brain
• at risk of, or after a stroke
• dehydration.

You should not be given this medicine if the solution is discoloured, cloudy, turbid, or a precipitate or particles are present. The solution is normally a clear, colourless to faintly straw-coloured liquid.

You should not be given this medicine if it causes a precipitate, discolouration or cloudiness to form when added to an intravenous (IV) solution.

You should not be given this medicine after the expiry date printed on the pack, or if the packaging is torn or shows signs of tampering. If you are given this medicine after the expiry date has passed, it may not work as well.

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

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• type II diabetes
• severe under-nutrition
• problems digesting carbohydrates or sugars
• vitamin B1(thiamine) deficiency
• chronic alcoholism
• low levels of potassium, magnesium or phosphorous
• blood poisoning or serious infection.
• recent IV (intravenous) infusion.

Tell your doctor if you are pregnant or planning to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If your child is to be given Glucose 50% tell your doctor if the mother suffers from diabetes. Glucose 50% should be used with caution in infants with diabetic mothers.

If you have not told your doctor about any of the above, tell him/her before you are given Glucose 50%.

Taking other medicines

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

Some medicines may interfere with Glucose 50%. These include:

• corticosteroids
• corticotrophin.

These medicines may be affected by Glucose 50%, 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 and pharmacist have more information on medicines to be careful with or avoid while being given this medicine.

How Glucose 50% is given

Glucose 50% must only be given by a doctor or nurse.

It is usually diluted by adding to an intravenous (IV) solution and then injected into a vein.

It may also be directly injected slowly into a vein without being diluted for some medical conditions.

Your doctor will decide what dose of glucose you will receive and for how long you will receive it. This depends on your medical condition and other factors, such as your weight.

If you are given too much (overdose)

Glucose 50% must only be given by a nurse or doctor so an overdose is not likely to occur.

Immediately contact your doctor if you notice the following symptoms of an overdose:

• mental confusion
• dehydration causing thirst or lack of urination.

While you are being given Glucose 50%

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Glucose 50%.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine. It may affect other medicines used during surgery.

If you are about to have any blood tests, tell your doctor that you have been given this medicine. It may interfere with the results of some tests.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Glucose 50%. This medicine 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.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

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

• flushing causing redness over face and/or body.

The above list includes the common side effect of your medicine. It is usually mild and short lived.

Tell your doctor or nurse immediately if any of the following happen:

• pain, burning or swelling at the site of injection
• swelling of the hands, ankles or feet
• symptoms caused by low levels of potassium, magnesium or phosphorus in the blood:
  - drowsiness
  - loss of appetite
  - muscle twitching or trembling
  - nausea or vomiting
  - unusual tiredness or weakness.

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell you doctor immediately or go to the Emergency Department at your nearest hospital:

• symptoms of an allergic reaction:
  - shortness of breath
  - wheezing or difficulty breathing
  - swelling of face lips tongue or other parts of the body
  - rash, itching or hives on the skin.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Some side effects can only be found when your doctor does tests from time to time to check your progress.

After using Glucose 50%

Storage

Glucose 50% will be stored in the surgery, pharmacy, or ward of a hospital. The injection is kept in a cool dry place where the temperature stays below 25°C.

Glucose 50% will be opened for use on you. It will be used only once and then it will be discarded. It will never be stored after it is opened or used for more than one person.

Product description

What it looks like

Glucose 50% is a clear, colourless to faintly straw-coloured solution in a clear glass vial sealed with a grey rubber stopper and aluminium seal with a white plastic flip off cap.

It is supplied in a 50 mL vial.

Ingredients

Glucose 50% contains 25 mg glucose as monohydrate in 50 mL equivalent to 500 mg/mL of glucose anhydrous in water for injections.

Sodium bicarbonate or hydrochloric acid may also be added for pH adjustment.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes or preservatives.

Manufacturer

Glucose 50% is made in Australia by:

Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia

Glucose 50% in 50 mL vial
AUST R 12420
Phebra product code - INJ128

This leaflet was amended in
Feb 2021.

Phebra and the Phi symbol are trademarks of Phebra Pty Ltd.

Published by MIMS March 2021

1 Name of Medicine

Glucose monohydrate.

2 Qualitative and Quantitative Composition

Glucose 50% contains glucose monohydrate 27.5 g in 50 mL equivalent to glucose anhydrous 25 g per 50 mL (500 mg/mL or 50%) in water for injections.
Glucose 50% is strongly hypertonic. The solution has a pH range of 3.5 to 6.5.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Glucose 50% is a clear, colourless to faintly straw coloured, particle-free solution for intravenous infusion.

4 Clinical Particulars

4.1 Therapeutic Indications

Glucose 50% intravenous infusion is strongly hypertonic and may be used to reduce increased cerebrospinal pressure and/or oedema due to delirium tremens or acute alcoholic intoxication. It may also be used to treat severe hypoglycaemia due to an excess of insulin and to provide concentrated calories in total parenteral nutrition regimes.

4.2 Dose and Method of Administration

Glucose 50% intravenous infusion is strongly hypertonic and must be administered via the intravenous (IV) route only. Except in the emergency treatment of severe hypoglycaemia, Glucose 50% intravenous infusion should be appropriately diluted and administered via an IV catheter carefully placed in a large central vein.
For emergency treatment of hypoglycaemia, Glucose 50% intravenous infusion may be administered slowly (e.g. 3 mL/minute) via a small bore needle carefully placed in a large peripheral vein.
The dose of glucose is dependent on the age, weight and fluid, electrolyte, glucose and acid/ base balance of the patient. The rate of infusion should not exceed 0.5 g/kg/hr to avoid glycosuria.

Acute hypoglycaemia.

Adults and children.

Neonates and infants.

4.3 Contraindications

Glucose 50% intravenous infusion is contraindicated in:
Diabetic coma while blood sugar levels are excessively high.
Glucose-galactose malabsorption syndrome.
Patients with anuria or intraspinal or intracranial haemorrhage and in dehydrated delirium tremens patients.
Patients at risk for ischaemic stroke. Use after an ischaemic stroke episode.
Patients with known allergy to corn (maize) and corn products.

4.4 Special Warnings and Precautions for Use

The use of hypertonic glucose solutions may result in dehydration, therefore, regular monitoring of the hydration status of the patient is recommended. It is important that hypertonic glucose solutions are administered slowly, because rapid administration may produce a local rise in the osmotic tension of the blood at the point of injection.
Intravenous administration of hypertonic glucose solutions may cause venous thrombosis, so it is important to employ proper techniques to avoid vein damage. It is recommended that the intravenous injection be given slowly, using a small bore needle and avoiding the walls of the vein if possible. The tourniquet should be removed as soon as venipuncture has occurred. Warming the arm and the solution to room temperature will help to avoid adverse sequelae.
Intravenous administration of glucose solutions, especially as infusions, may cause fluid overload with a resultant dilution of serum electrolytes and possible peripheral and pulmonary oedema. Prolonged therapy should be monitored for changes in fluid balance, electrolyte concentration and acid/ base balance.
Glucose solutions should be used with caution in patients with subclinical diabetes mellitus, severe undernutrition or with carbohydrate intolerance.
Hyperglycaemia and glycosuria may occur as a result of an over rapid rate of infusion or metabolic insufficiency. Blood and urine glucose should be monitored regularly.
Avoid use after an ischaemic stroke episode as, under this condition, the induced lactic acidosis aggravates the recovery of the damaged brain tissue. Thiamine diphosphate cocarboxylase is an essential coenzyme in carbohydrate metabolism, therefore, patients having thiamine deficiency should be treated cautiously with glucose injection. This is particularly important in patients who chronically abuse alcohol as this may precipitate an overt deficiency syndrome, e.g. Wernicke's encephalopathy.
Glucose solutions should not be infused concomitantly through the same IV set as blood, because agglomeration or haemolysis may occur.
Cautious use of glucose solutions is required in patients with thiamine deficiency, hypokalaemia, hypophosphataemia, hypomagnesaemia, haemodilution, sepsis and trauma.
Prolonged parenteral administration of glucose may affect insulin production. To avoid this it may be necessary to add insulin to the infusion. A review of a patient's oral hypoglycaemic or insulin requirements may be necessary. Additives may be incompatible with glucose. Do not administer such preparations unless the solution is clear. Do not store solutions containing additives unless compatibility has been proven. While some incompatibilities are readily observed, one must be aware that subtle physical, chemical and pharmacological incompatibilities can occur. The medical literature, the package insert and other available sources of information should be reviewed for a thorough understanding of possible incompatibility problems. In particular, the product information document of any added medication should be checked for any incompatibility with Glucose 50%.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Parenteral fluids, especially those containing sodium ions, should be administered with caution to patients receiving corticosteroids or corticotropin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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)

Intravenous administration of hypertonic glucose solutions may cause local phlebitis or venous thrombosis and extravasation. If the solution is infused too rapidly, local pain and vein irritation may occur. A fever response and infection at the site of injection may also occur due to contamination of the solution or poor techniques of administration.
Hyperglycaemia and glycosuria may occur if glucose is administered at a rate greater than 0.5 g/kg/hr. Disruption of the fluid and acid/ base balance and dilution of electrolyte concentrations may occur during prolonged usage, resulting in oedema, hypokalaemia, hypomagnesaemia and hypophosphataemia (see Section 4.4 Special Warnings and Precautions for Use).
Vitamin B complex deficiency may occur with glucose administration.
High concentrations of glucose administered intravenously may induce an increased histamine release from blood cells resulting in anaphylactoid reactions. Anaphylactoid effects have been reported in two patients with both asthma and diabetes mellitus.
Rapid infusion of glucose 25-30 g over 3 minutes may occasionally cause a generalised flush. This subsides within 10 minutes.

Reporting suspected adverse reactions.

4.9 Overdose

Hyperglycaemia and glycosuria, if undetected, can lead to mental confusion, dehydration, hyperosmolar coma and death. Appropriate treatment may include decreasing the infusion rate of glucose and administration of insulin.
Fluid overload and biochemical imbalance resulting from overdosage with glucose solution should be treated with appropriate corrective therapy.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Glucose 50% is a sterile solution of anhydrous glucose in water for injections, adjusted to pH 3.5-6.5 with sodium bicarbonate or hydrochloric acid.

6.2 Incompatibilities

See Section 4.4 Special Warnings and Precautions for Use; 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 ARTG¹. The expiry date can be found on the packaging.
¹ AUST R 12420.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

It is presented in a 50 mL glass vial as a pack of 10.
Phebra product code INJ128.

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 name: monohydrate of (+)-D-glucopyranose.
The molecular weight of the compound is 198.2. The molecular formula is C₆H₁₂O_6.H₂O.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes