SUMMARY CMI

Calcium Gluconate Injection

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Calcium Gluconate Injection?

Calcium Gluconate Injection contains the active ingredient calcium gluconate monohydrate. Calcium Gluconate Injection is used to treat or prevent a lack of calcium in the body. Other reasons for treatment are high blood potassium levels, magnesium sulfate overdose (i.e. Epsom salts), sudden severe stomach pain and during heart resuscitation to strengthen the heart muscles.

For more information, see Section 1. Why am I using Calcium Gluconate Injection? in the full CMI.

2. What should I know before I use Calcium Gluconate Injection?

Do not use if you have ever had an allergic reaction to calcium gluconate monohydrate or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Calcium Gluconate Injection? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Calcium Gluconate Injection and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Calcium Gluconate Injection?

• Calcium Gluconate Injection must only be given by a doctor or nurse and warmed to body temperature before use.
• Calcium Gluconate Injection is usually given as a slow injection or infusion into a vein.

More instructions can be found in Section 4. How do I use Calcium Gluconate Injection? in the full CMI.

5. What should I know while using Calcium Gluconate Injection?

For more information, see Section 5. What should I know while using Calcium Gluconate Injection? in the full CMI.

6. Are there any side effects?

Calcium Gluconate Injection may cause a tingling sensation, heat or heaviness feeling over the body, calcium or chalky taste, dizziness, feeling faint, irregular, fast or slow heartbeat, chest pain, nausea or vomiting, loss of appetite, constipation, abdominal pain, sweating, hot flushes, skin redness, pain or burning at the injection site, muscle or joint pain, tiredness or weakness and excessive thirst or urination.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Calcium Gluconate Injection

Active ingredient: calcium gluconate monohydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Calcium Gluconate Injection. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Calcium Gluconate Injection.

Where to find information in this leaflet:

1. Why am I using Calcium Gluconate Injection?
2. What should I know before I use Calcium Gluconate Injection?
3. What if I am taking other medicines?
4. How do I use Calcium Gluconate Injection?
5. What should I know while using Calcium Gluconate Injection?
6. Are there any side effects?
7. Product details

1. Why am I using Calcium Gluconate Injection?

Calcium Gluconate Injection contains the active ingredient calcium gluconate monohydrate. Calcium Gluconate Injection belongs to a group of medicines called calcium salts.

Calcium Gluconate Injection is used to treat or prevent a lack of calcium in the body.

Other reasons for treatment with Calcium Gluconate Injection are:

• high potassium in the blood
• an overdose of magnesium sulfate (i.e. Epson salts)
• sudden severe stomach pain
• during heart resuscitation to strengthen the heart muscle.

Calcium Gluconate Injection works by increasing the level of calcium in the blood or by binding to excess potassium or magnesium in the blood.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

2. What should I know before I use Calcium Gluconate Injection?

Warnings

Do not use Calcium Gluconate Injection if:

• you are allergic to calcium gluconate monohydrate, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine
• the calcium levels in your blood or urine are above normal levels
• you have severe heart disease
• you have severe kidney disease
• you suffer from galactose (a sugar) in the blood
• you have been bedridden for a long time causing the loss of calcium from the bones
• you are being treated with certain heart drugs such as digoxin and digitalis
• the calcium gluconate solution is discoloured, cloudy, turbid, or a precipitate is present
• when diluted with another solution it causes the solution to precipitate, become cloudy, turbid, discolour, or particles are visible.

Check with your doctor if you have or have had:

• kidney or heart disease
• kidney stones or stones of the urinary tract
• diseases causing high levels of vitamin D in the blood
• dehydration or any other chemical imbalance in the blood
• high phosphate levels in the blood
• a blood transfusion.
• take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

If you have not told your doctor about any of the above, tell him/her before you are given Calcium Gluconate Injection.

3. What if I am taking other medicines?

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

Some medicines may interfere with Calcium Gluconate Injection and affect how it works.

These include:

• medicines used to treat heart disease such as cardiac glycosides (e.g. Digoxin or digitalis)
• tetracycline antibiotics such as Achromycin and Tetrex
• high doses of vitamin D or vitamin A
• medicines used to treat Paget's disease such as calcitonin
• medicines used to reduce blood pressure such as verapamil and other calcium channel blockers
• medicines used to reduce excess fluid in the body such as thiazide diuretics
• medicines used to relax muscles before surgery such as tubocurarine
• medicines containing calcium, magnesium, potassium phosphate or sodium phosphate.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Calcium Gluconate Injection.

4. How do I use Calcium Gluconate Injection?

How much to use

• Your doctor will decide what dose of Calcium Gluconate Injection you will receive and for how long you will receive it.

When to use Calcium Gluconate Injection

• Calcium Gluconate Injection will only be opened when it is time for you to have the injection.
• Calcium Gluconate Injection should be warmed to body temperature before use and must only be given by a doctor or nurse.

If you given too much Calcium Gluconate Injection

Overdose is unlikely to occur as Calcium Gluconate Injection must only be given by a doctor or nurse. Your doctor or nurse will monitor the level of calcium in the blood. Some medical conditions may result in too much calcium in the blood, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre (by calling 13 11 26), or the New Zealand National Poisons Centre (by calling 0800 POISON or 0800 764 766), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Calcium Gluconate Injection?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Calcium Gluconate Injection.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given Calcium Gluconate Injection.

If you are about to have any blood tests, tell your doctor that you have been given Calcium Gluconate Injection.

Keep all of your doctor's appointments so that your progress can be checked.

Call your doctor straight away if you:

• become pregnant during the course of Calcium Gluconate Injection treatment.

Remind any doctor, dentist, pharmacist or nurse you visit that you have been given Calcium Gluconate Injection.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Calcium Gluconate Injection affects you.

Calcium Gluconate Injection may cause dizziness, light-headedness or weakness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else dangerous.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. If this problem continues or gets worse, talk to your doctor.

Looking after your medicine

• Calcium Gluconate Injection will be stored below 30°C in the surgery, pharmacy or ward of a hospital.

Keep it where young children cannot reach it.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Calcium Gluconate Injection contains

Calcium Gluconate Injection does not contain lactose, sucrose, gluten, tartrazine, alcohol, dyes or any preservatives.

Do not take this medicine if you are allergic to any of these ingredients.

What Calcium Gluconate Injection looks like

Calcium Gluconate Injection is a clear colourless solution in a clear glass vial sealed with a chlorobutyl grey rubber stopper and an aluminium seal with a white plastic flip-off cap. (AUST R 355191).

Who distributes Calcium Gluconate Injection

Calcium Gluconate Injection is supplied in Australia by:

Phebra Pty Ltd
19 Orion Road, Lane Cove West,
NSW 2066, Australia.
Telephone: 1800 720 020

This leaflet was prepared in July 2021.

Published by MIMS February 2022

1 Name of Medicine

Calcium gluconate monohydrate.

2 Qualitative and Quantitative Composition

Calcium gluconate is a supersaturated solution. Supersaturated solutions are prone to precipitation. Examine the vial and do not use if a precipitate is present.
The 10 mL injection is a solution containing 931 mg calcium gluconate and 46 mg calcium saccharate in water for injections. The calcium saccharate is a BP approved stabiliser for the supersaturated solution.
Each 10 mL of the injection contains:
89 milligrams of calcium ions;
equivalent to 2.2 millimoles of calcium ions;
equivalent to 4.4 mEq of calcium ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The injection is a clear and colourless, particle free solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Calcium gluconate is a calcium salt used primarily for the prevention and treatment of calcium deficiency.
Parenteral administration of calcium gluconate is needed in acute hypocalcaemia and hypocalcaemic tetany. It can be given intravenously in the treatment of severe hyperkalaemia and in overdosage of magnesium sulphate, as calcium is the antagonist of magnesium toxicity. Intravenous injections have been used in the treatment of acute renal, biliary and intestinal colic. Calcium has been used as an inotrope in cardiac resuscitation. They may also be used for the prevention of hypocalcaemia in exchange transfusions, and in long term electrolyte replacement therapy.

4.2 Dose and Method of Administration

Calcium Gluconate Injection is a supersaturated solution. Supersaturated solutions are prone to precipitation. Examine the vial and do not use if a precipitate is present.
Calcium gluconate is usually administered intravenously as a 10% solution by slow intravenous injection, or by continuous or intermittent intravenous infusion.
It is not recommended to be given by intramuscular and subcutaneous injection, due to the possibility of tissue necrosis, and it should never be given by this route in children.
Various maximum rates of administration have been recommended for direct intravenous injection, including 2 mL/min, 1.5 to 3 mL/min, and 5 mL/min. By intermittent infusion, a maximum rate of 2 mL/min (0.9 mEq of calcium ions/min) is suggested. During intravenous administration of calcium, close monitoring of serum calcium levels is essential.

Hypocalcaemia and hypocalcaemic tetany.

Adults.

Severe hyperkalaemia.

Hypermagnesaemia.

Adults.

Parenteral nutrition.

Children.

4.3 Contraindications

Calcium Gluconate Injection should not be given concurrently with digitalis or cardiac glycoside therapy.
Also it is not to be used in hypercalcaemia, hypercalciuria (e.g. hyperparathyroidism, vitamin D overdosage, decalcifying tumours such as plasmacytoma, bone metastases), and severe renal disease, severe cardiac disease and calcium loss due to immobilisation.
It is not advisable to administer calcium gluconate to galactosaemic patients.
It is contraindicated when serum calcium concentrations are above normal levels (i.e. 4.5 to 5.2 mEq/L).
Calcium Gluconate Injection should not be given via the intramuscular or subcutaneous routes, as necrosis or sloughing may occur.

4.4 Special Warnings and Precautions for Use

Calcium gluconate and calcium chloride are presented in 10 mL vials at 10% (w/v) for injection but are not equivalent in calcium content:
10 mL of calcium gluconate 10% solution for injection/infusion BP contains 2.2 mmol calcium;
10 mL of calcium chloride 10% solution contains 6.8 mmol of calcium.
The difference in calcium content should be accounted for to achieve the correct calcium dose when using either salt to avoid medication errors.
Calcium Gluconate Injection is a supersaturated solution. Supersaturated solutions are prone to precipitation. Examine the vial and do not use if a precipitate is present.
Intramuscular injection in infants has been reported to cause abscess formation. The oral or intravenous route is to be used.
Solutions of calcium salts, particularly calcium chloride, are irritants, and care should be taken to prevent extravasation during intravenous injection.
Calcium Gluconate Injection should be administered slowly through a small needle into a large vein to avoid too rapid an increase in serum calcium and extravasation into the surrounding tissue (see Section 4.8 Adverse Effects (Undesirable Effects)). Slow intravenous injection also helps prevent high concentrations of calcium from reaching the heart and causing cardiac syncope. Administration should be temporarily discontinued if abnormal ECG readings or patient discomfort occur; it may be resumed following resolution of the abnormal ECG reading or discomfort.
The injection should be warmed to body temperature prior to administration unless emergency administration is required. Following injection, the patient should lie down for a short period of time, to prevent dizziness.
Calcium salts should be given cautiously to patients with impaired renal function, cardiac disease, or diseases associated with elevated vitamin D concentrations such as sarcoidosis. Calcium salts should generally be avoided in patients with calcium renal calculi, or with a history of renal calculi. When used in large doses, serum calcium concentrations and kidney function should be determined weekly or at the first sign of hypercalcaemia, which is characterised by symptoms such as anorexia, lassitude, muscle and joint pains, nausea and vomiting, thirst, and polyuria.
Dehydration or other electrolyte imbalances may increase the risk of hypercalcaemia.
Ventricular fibrillation present during cardiac resuscitation increases the risk of arrhythmias after calcium administration. Frequent determinations of serum calcium concentrations should be performed, particularly in children. Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure. Since hypercalcaemia may be more dangerous than hypocalcaemia, over treatment of hypocalcaemia should be avoided.
In mild hypercalciuria (exceeding 300 milligrams/24 hours) as well as in chronic renal failure, or when there is evidence of stone formation in the urinary tract, adequate checks must be kept on urinary calcium excretion. If necessary the dosage should be reduced or calcium therapy discontinued. In patients prone to formation of calculi in the urinary tract an increased fluid intake is recommended.
ECG monitoring is required when calcium is administered by intravenous injection for treating severe hyperkalaemia.
In patients with severe hypocalcaemia and hyperphosphataemia, the hyperphosphataemia should be treated prior to administration of intravenous calcium. Treatment should aim to achieve a proper calcium/phosphate ratio to prevent extra-skeletal deposition of calcium.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Cardiac glycosides.

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)

Calcium salts are irritating to tissue when administered by intramuscular or subcutaneous injection and cause mild to severe local reactions including burning, necrosis and sloughing of tissue, cellulitis, and soft tissue calcification. Calcium Gluconate Injection should, therefore, not be administered by intramuscular or subcutaneous injection (see Section 4.3 Contraindications).
Venous irritation may occur with intravenous administration. When injected intravenously, calcium salts should be administered slowly through a small needle into a large vein to avoid too rapid an increase in serum calcium and extravasation of calcium solution into the surrounding tissue with resultant necrosis.
Patients may complain of tingling sensations, a sense of oppression or heat waves, and a calcium or chalky taste following intravenous administration of calcium salts. Other adverse effects commonly associated with parenteral calcium administration include hypotension or dizziness, irregular heartbeat, nausea or vomiting, or sweating. Skin redness, rash, pain or burning at the injection site are also common; these reactions may indicate extravasation, and can precede sloughing or skin necrosis. Severe necrosis requiring skin grafting, and calcification can occur at the injection site, especially after rapid intravenous injection. Rapid intravenous injection of calcium salts may cause vasodilation, hot flushes, decreased blood pressure, bradycardia, cardiac arrhythmias, syncope, and cardiac arrest.
Transient increases in blood pressure, particularly in elderly or hypertensive patients, may occur during intravenous administration of calcium salts.
Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure (see Section 4.9 Overdose). Since hypercalcaemia may be more dangerous than hypocalcaemia, overtreatment of hypocalcaemia should be avoided.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms of overdosage.

Treatment of overdosage.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The injection contains 46 mg calcium saccharate in water for injections. Calcium saccharate is an approved stabiliser for supersaturated solution.

6.2 Incompatibilities

Calcium Gluconate Injection has been reported as being incompatible with the following solutions: fat emulsion 10% intravenous; cefamandole nafate; cephalothin sodium; dobutamine HCl; floxacillin sodium; methylprednisolone sodium succinate; prochlorperazine edisylate; metoclopramide HCl; aldesleukin; indomethacin sodium trihydrate; phosphates; soluble carbonates, phosphates and sulphates.

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)¹. The expiry date can be found on the packaging.
¹ AUST R 355191.

6.4 Special Precautions for Storage

Store below 30°C. Do not refrigerate.

6.5 Nature and Contents of Container

The injection is supplied in a 10 mL Type 1 glass vial with a chlorobutyl stopper (not made with natural rubber latex) and an aluminium seal capped with a white flip off seal. Each carton contains 10 vials.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The molecular weight of the compound is 448.4. The molecular formula is C₁₂H₂₂CaO₁₄.H₂O.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes