Consumer medicine information

Calcium Gluconate Injection

Calcium gluconate monohydrate

BRAND INFORMATION

Brand name

Calcium Gluconate Injection

Active ingredient

Calcium gluconate monohydrate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Calcium Gluconate Injection.

What is in this leaflet

This leaflet answers some common questions about Calcium Gluconate Injection. 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 Calcium Gluconate Injection 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. You may need to read it again.

What Calcium Gluconate Injection is used for

Calcium gluconate is a calcium salt used to treat or prevent a lack of calcium in the body. Other reasons for treatment with Calcium Gluconate Injection are:

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

This medicine 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.

Before you are given Calcium Gluconate Injection

When you must not be given it

You should not be given Calcium Gluconate Injection if you have an allergy to:

  • any medicine containing calcium gluconate
  • 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.

You should not be given Calcium Gluconate Injection if the calcium levels in your blood or urine are above normal levels. Some conditions that may cause high levels of calcium are:

  • hyperparathyroidism, an over production of certain hormones
  • an overdose of vitamin D
  • tumours of the bone or other tumours which raise levels of calcium in the blood.

You should not be given Calcium Gluconate Injection if you have severe heart disease.

You should not be given Calcium Gluconate Injection if you have severe kidney disease.

You should not be given Calcium Gluconate Injection if you suffer from galactosaemia. This is a rare genetic disorder.

You should not be given Calcium Gluconate Injection if you have been bed ridden for a long time causing the loss of calcium from the bones.

You should not be given Calcium Gluconate Injection if you are being treated with certain heart drugs such as digoxin and digitalis.

You should not be given Calcium Gluconate Injection if the solution is discoloured, cloudy, turbid, or a precipitate is present. The solution is normally a clear, colourless liquid.

You should not be given Calcium Gluconate Injection if when diluted with another solution it causes the solution to precipitate, become cloudy, turbid, discolour, or particles are visible.

The doctor or nurse will check to ensure the medicine is not past its expiry date and has not been tampered with.

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:

  • 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.

Tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding. Your doctor will discuss the risks and benefits of you being given Calcium Gluconate Injection during pregnancy and breast-feeding.

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

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 and calcium gluconate may interfere with each other. These include:

  • medicines used to treat heart disease such as cardiac glycosides eg 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 prior to surgery such as tubocurarine
  • medicines containing calcium, magnesium, potassium phosphate or sodium phosphate.

These medicines may be affected by Calcium Gluconate Injection or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor or pharmacist have more information on medicines to be careful with or avoid while being given Calcium Gluconate Injection.

How Calcium Gluconate Injection is given

Calcium Gluconate Injection must only be given by a doctor or nurse.

How it is given

It is usually given as a slow injection or infusion into a vein.

Calcium Gluconate Injection will normally be warmed to body temperature before use.

How much is given

Your doctor will decide what dose of calcium gluconate you will receive and for how long you will receive it. This depends on your medical condition and other factors, such as your weight. Sometimes only a single dose of calcium gluconate is required.

If you are given too much (overdose)

Calcium Gluconate Injection must only be given by a doctor or nurse so an overdose is unlikely to occur.

Some medical conditions may result in too much calcium in the blood. Your doctor or nurse will monitor the level of calcium in the blood.

If you notice any symptoms of an overdose contact your doctor immediately or go to the Emergency Department at the nearest hospital.

Symptoms of an overdose may include:

  • nausea, vomiting
  • loss of appetite
  • abdominal pain, constipation
  • weakness in the muscles and painful joints
  • excessive thirst and excessive passing of urine
  • change in heart beat or chest pain.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

While you are being given Calcium Gluconate Injection

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 Calcium Gluconate Injection.

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 become pregnant while being given this medicine, tell your doctor immediately.

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.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how Calcium Gluconate Injection affects you. This medicine 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. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Calcium Gluconate Injection. 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 this list of possible 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:

  • tingling sensation
  • a feeling of heat or heaviness over the body
  • a calcium or chalky taste.

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

  • dizziness, feeling faint
  • irregular, fast or slow heart beat, chest pain
  • nausea or vomiting, loss of appetite
  • constipation or abdominal pain
  • sweating, hot flushes
  • skin redness, pain or burning at injection site
  • muscle or joint pain
  • tiredness or weakness
  • excessive thirst or urination.

The above list includes very serious side effects. These side effects are very rare.

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

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

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

After being given Calcium Gluconate Injection

After you have been given Calcium Gluconate Injection you should lie down for a short time to prevent dizziness.

If you feel light-headed or dizzy when getting up, get up slowly. Standing up slowly will help your body get used to the change in position and blood pressure.

If this problem continues or gets worse, talk to your doctor or nurse.

Storage

Calcium Gluconate Injection 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 30°C but not refrigerated.

Calcium Gluconate Injection will only be opened when it is time for you to have the injection.

Product description

What it looks like

Calcium Gluconate Injection is a clear colourless solution in a clear glass vial sealed with a grey rubber stopper and aluminium seal with a white plastic flip off cap.

The vial stopper is not made with natural rubber latex.

Calcium Gluconate Injection is available in a 10 mL vial.

Ingredients

Calcium Gluconate Injection contains 95 mg/mL calcium gluconate monohydrate and 3.0 mg/mL calcium saccharate in water for injections.

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

Manufacturer

Calcium Gluconate Injection is made in Australia by:

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

Calcium Gluconate Injection 2.2 mmol of calcium in 10 mL vial.
AUST R 22923

Phebra product code- INJ022

This leaflet was prepared in Mar 2020.

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

Published by MIMS May 2020

BRAND INFORMATION

Brand name

Calcium Gluconate Injection

Active ingredient

Calcium gluconate monohydrate

Schedule

Unscheduled

 

1 Name of Medicine

Calcium Gluconate monohydrate.

6.7 Physicochemical Properties

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

Chemical structure.


CAS number.

18016-24-5.

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.
Calcium Gluconate Injection is a solution containing 95.3 mg/mL calcium gluconate and 3.0 mg/mL calcium saccharate in water for injections BP. The calcium saccharate is a BP approved stabiliser for the supersaturated solution.
Each mL of the injection contains:
8.9 milligrams of calcium ions;
equivalent to 0.22 millimoles of calcium ions;
equivalent to 0.44 mEq of calcium ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Calcium Gluconate Injection is a viscous, supersaturated, colourless solution.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Calcium is essential for the maintenance of the functional integrity of the nervous, muscular and skeletal systems, and cell membrane and capillary permeability. This cation is an important activator in many enzymatic reactions and is essential to a number of physiologic processes including the transmission of nerve impulses; contraction of cardiac, smooth and skeletal muscles; renal function; respiration; and blood coagulation. Calcium also plays a regulatory role in the release and storage of neurotransmitters and hormones, in the uptake and binding of amino acids, in cyanocobalamin (vitamin B12) absorption and in gastrin secretion.
The calcium of bone is in a constant exchange with the calcium of plasma. Since the metabolic functions of calcium are essential for life, when there is a disturbance in the calcium balance because of dietary deficiency or other causes, the stores of calcium in bone may be depleted to fill the body's more acute needs. Therefore, on a chronic basis, normal mineralisation of bone depends on adequate amounts of total body calcium.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Dietary calcium is absorbed from the small intestine. About one-third of ingested calcium is absorbed, although this can vary depending upon dietary factors and the state of the small intestine.
Following absorption, calcium first enters the extracellular fluid and is then rapidly incorporated into skeletal tissue. Bone formation, however, is not stimulated by administration of calcium. Bone contains 99% of the body's calcium; the remaining 1% is distributed equally between the intracellular and extracellular fluids.
Normal total serum calcium concentration ranges from 9 to 10.4 mg/dL (4.5-5.2 mEq/L), but only ionised calcium is physiologically active. Serum calcium concentrations are not necessarily accurate indications of total body calcium; total body calcium may be decreased in the presence of hypercalcaemia, and hypocalcaemia can occur even though total body calcium is increased. Of the total serum calcium concentration, 50% is in the ionic form and 5% is complexed by phosphates, citrates and other anions. Approximately 45% of the serum calcium is bound to plasma proteins; for a change in serum albumin of 1 g/dL, the serum calcium concentration may change about 0.8 mg/dL (0.04 mEq/dL). Hyperproteinaemia is associated with increased total serum calcium concentrations; in hypoproteinaemia, total serum calcium concentrations decrease. Acidosis results in increased concentrations of ionic calcium, while alkalosis promotes a decrease in the ionic serum calcium concentration.

Distribution.

Cerebrospinal fluid (CSF) concentrations of calcium are about 50% of serum calcium concentrations and tend to reflect ionised serum calcium concentrations. Calcium crosses the placenta and reaches higher concentrations in foetal blood than in maternal blood. Calcium is distributed into milk.

Metabolism.

No data available.

Excretion.

Calcium is excreted mainly in the faeces and consists of unabsorbed calcium and that which is secreted via bile and pancreatic juice into the lumen of the GI tract. Most of the calcium filtered by renal glomeruli is reabsorbed in the ascending limb of the loop of Henle and proximal and distal convoluted tubules. Only small amounts of the cation are excreted in urine. Parathyroid hormone, vitamin D and thiazide diuretics decrease urinary excretion of calcium, whereas other diuretics, calcitonin and growth hormone promote renal excretion of the cation. Urinary excretion of calcium decreases with reduction of ionic serum calcium concentrations but is proportionately increased as serum ionised calcium concentrations increase. In healthy adults on a regular diet, urinary excretion of calcium may be as high as 250 to 300 mg daily. With low calcium diets, urinary excretion usually does not exceed 150 mg daily. Urinary excretion of calcium decreases during pregnancy and in the early stages of renal failure. Calcium is also excreted by the sweat glands.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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.

4.3 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 plasmocytoma, 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 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 mg/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 extraskeletal deposition of calcium.

Use in the elderly.

See Section 4.8 Adverse Effects (Undesirable Effects).

Paediatric use.

Intramuscular injection in infants has been reported to cause abscess formation. The oral or intravenous route is to be used.
See Section 4.2 Dose and Method of Administration, Parenteral nutrition.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Cardiac glycosides.

The inotropic and toxic effects of cardiac glycosides and calcium are synergistic and arrhythmias may occur if these drugs are given together (particularly when calcium is given intravenously). Intravenous administration of calcium should be avoided in patients receiving cardiac glycosides (see Section 4.3 Contraindications). If considered necessary, calcium should be given slowly in small amounts. Close electrocardiograph (ECG) monitoring is recommended.

Tetracyclines.

Calcium is known to complex with tetracycline antibiotics, thus rendering them inactive. The two drugs should therefore not be mixed prior to parenteral administration.
Vitamin D increases the gastrointestinal absorption of calcium (e.g. from dietary sources). High vitamin D intake should be avoided during calcium therapy unless especially indicated. Plasma calcium concentrations should be monitored in patients taking these drugs concurrently.
Administration of calcium may reduce the response to verapamil and possibly other calcium channel blockers.
Calcium salts may antagonise the effect of calcitonin in the treatment of hypercalcaemia. However, when calcitonin is used to treat Paget's disease, sufficient calcium should be administered to prevent hypocalcaemia and secondary hypoparathyroidism.
Concurrent use of thiazide diuretics with calcium may result in hypercalcaemia, as thiazide diuretics reduce urinary calcium excretion. Serum calcium levels should be monitored in patients receiving these drugs concurrently.
The effects of nondepolarising neuromuscular blocking agents are usually reversed by concurrent administration of parenteral calcium salts. Calcium salts may enhance or prolong the neuromuscular blocking action of tubocurarine.
Concurrent administration of calcium salts with other calcium containing preparations or with oral magnesium containing preparations may increase serum calcium or magnesium concentrations in susceptible patients, particularly those with impaired renal function, leading to hypercalcaemia or hypermagnesaemia, respectively.
Concurrent use of calcium salts with potassium and/or sodium phosphates may increase the potential for calcium to be deposited in soft tissues in the presence of high serum calcium levels.
Excessive vitamin A intake may stimulate bone loss, counteracting the effects of calcium administration on bone, and may cause hypercalcaemia.
Administration of calcium in patients who have received transfusions of citrated blood may result in higher than normal total serum calcium concentrations. In overdose hypercalcaemia may occur, especially when given to patients with chronic renal failure. Symptoms include anorexia, lassitude, muscle and joint pains, nausea, vomiting, thirst and polyurea. Deposition of calcium in the kidneys leads to renal damage. Elevated serum calcium concentrations can produce bradycardia and cardiac arrhythmias. Treatment consists of withdrawing all calcium supplements, administering large volumes of fluid, and in mild cases, sodium phosphate, sulphate chloride or citrate may be given intravenously. Frusemide and ethacrynic acid may be useful adjuncts. In these patients, however, most of the excess calcium is bound to citrate and is inactive; therefore, serious toxicity usually does not result.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
There is no information available on the use of Calcium Gluconate Injection during pregnancy. Calcium crosses the placenta, and reaches higher concentrations in foetal blood than in maternal blood. The decision to treat pregnant women with Calcium Gluconate Injection should therefore consider the potential benefits to the mother against the potential harm to the foetus.
Calcium crosses into breast milk. No problems have been documented with women who are breastfeeding when having the Calcium Gluconate Injection administered, but the potential benefits to the mother against the potential harm to the infant must be weighed.

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 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

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.

The usual initial dose is 7 to 14 mEq, but this is dependent upon the requirements of the individual patient. In hypocalcaemic tetany doses of 4.5 to 16 mEq may be administered until response occurs. The maximum daily dose of calcium gluconate should not exceed 15 g (equivalent to 67.5 mEq of calcium ions).

Severe hyperkalaemia.

Calcium salts may be given intravenously in doses of 4.5 to 9.0 mEq as an adjunct, repeated as required under ECG control.

Hypermagnesaemia.

Adults.

An initial dose of 7 mEq intravenously may be given with subsequent doses adjusted according to the response.

Parenteral nutrition.

Calcium salts may be added to parenteral nutrition solutions to prevent hypocalcaemia.

Children.

Initial dose 1 to 7 mEq, but this must always be tailored to the needs of the individual patient. This dose may be repeated every one to three days if necessary. For children with hypocalcaemic tetany, doses of 0.5 to 0.7 mEq/kg may be repeated every 8 hours until response is seen.
To assist dosing Table 1 shows the calcium level in different volumes of the injection.

Compatibilities.

It is recommended that Calcium Gluconate Injection be diluted with either 0.9% sodium chloride, 5% glucose in water, lactated Ringers injection, or 5% glucose in 0.9% sodium chloride when intended to be administered as an intravenous infusion. It has been reported that at a concentration of 1.0 to 2.0 g/L calcium gluconate is compatible in all of the infusion fluids listed above for 24 hours.
To reduce microbiological contamination hazards, it is recommended that any further dilution of the product should be done immediately prior to use and infusion commenced as soon as practicable after preparation of the mixture. Infusion should be completed within 24 hours and any residue discarded. Any solutions which are discoloured, hazy or contain visible particulate matter should not be used.
The phenomenon of compatibility/ incompatibility of calcium salts with phosphates in solution is a very complex one and may be affected by solubility and concentration phenomena, pH, as well as temperature and time of storage of the admixture and the presence of other substances. Consequently, Calcium Gluconate Injection should not be further diluted with phosphate containing infusion fluids.

Incompatible solutions.

See Section 6.2 Incompatibilities.
Do not use if solution is discoloured, cloudy, turbid, or if a precipitate is present.

Compatible solutions.

Calcium Gluconate Injection should be diluted with either 0.9% sodium chloride, 5% glucose in water, lactated Ringer injection, or 5% glucose in 0.9% sodium chloride, as an intravenous infusion. To reduce contamination hazards, any further dilution of the product should be done immediately prior to use, and infusion commenced as soon as possible after preparation of the mixture. Infusion should be completed in 24 hours and any residue must be discarded. Any solution which is discoloured, hazy or contains visible particulate matter should not be used. Calcium Gluconate Injection should not be diluted with infusion fluids containing phosphates. (See Section 6.2 Incompatibilities.)
Calcium Gluconate Injection is a supersaturated solution stabilised with calcium saccharate.

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 of overdosage.

Hypercalcaemia may occur when large doses of calcium gluconate are given, especially when such doses are given to patients with chronic renal failure. Symptoms of hypercalcaemia include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, renal calculi, and in severe cases, cardiac arrhythmias, coma and cardiac arrest.

Treatment of overdosage.

A serum calcium concentration exceeding 10.5 mg/100 mL (2.6 mmol/L) is considered a hypercalcaemic condition. Withholding additional administration of calcium and any other medications that may cause hypercalcaemia usually resolves mild hypercalcaemia in asymptomatic patients, when renal function is adequate.
When serum calcium concentrations are greater than 12 mg/100 mL, immediate measures may be required with possible use of the following.
Hydration with intravenous 0.9% sodium chloride injection and forced diuresis with frusemide to rapidly increase calcium excretion.
Monitoring of potassium and magnesium serum concentrations and early replacement to prevent complications of therapy.
ECG monitoring and the possible use of β-adrenergic blocking agents to protect the heart against serious arrhythmias.
Possible treatment with calcitonin, diphosphonate dmp and other measures.
Determining serum calcium concentrations at frequent intervals to guide therapy adjustments.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Calcium Gluconate Injection contains 3.0 mg/mL calcium saccharate in water for injections BP. The calcium saccharate is a BP approved stabiliser for the 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). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Do not refrigerate.

6.5 Nature and Contents of Container

Calcium Gluconate Injection is supplied as 10 mL in a 10 mL glass vial as a pack of 10.
AUST R 22923.
Phebra product code: INJ022.
The vial stopper is not made with natural rubber latex.

6.6 Special Precautions for Disposal

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

Summary Table of Changes