Calcium Gluconate

Registered South African indications:

• Calcium supplementation (all conditions where indicated)

Contraindications 

• Hypersensitivity to the active ingredient or any of its  excipients
• Severe renal impairment
• Patients with hypercalcaemia
  - Hyperparathyroidism
  - Hypervitaminosis D
  - Neoplastic disease with decalcification of bone
  - Renal insufficiency
  - Immobilisation osteoporosis
  - Sarcoidosis
  - Milk-alkali syndrome
• Hypercalciuria
• Repeated or prolonged treatment, including as an IV infusion, in children (<18 years) and those with impaired renal function (See additional prescribing points)
• Coadministration with ceftriaxone in premature newborns up to a corrected age of 41 weeks (weeks of gestation + weeks of life) and full-term newborns (up to 28 days of age) (See additional prescribing points)
• Coadministration with cardiac glycosides

Cautions

• Pregnancy
• Breastfeeding
• Mild to moderate renal impairment
• Hepatic impairment
• Evidence of calculi formation within the urinary tract
• If plasma calcium exceeds 2.75mmol per litre or if 24 hour urinary calcium excretion exceeds 5mg/kg
• Nephrocalcinosis
• Heart disease
• Sarcoidosis (Boeck's disease)
• Admixture with incompatible agents (See additional prescribing points)
• Rapid IV administration
• High doses
• Coadministration with high-dose vitamin D
• Coadministration with epinephrine

Forms avail. in SA and covered in this monograph: inj

Acute hypocalcaemia

• IV (10% sol): 10-20ml (2.2-2.4mmol)

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The normal concentration of calcium in plasma is within the range of 2.25-2.75mmol or 4.5-5.5mEq per litre. Treatment should be aimed at restoring or maintaining this level

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Fluoride or lead poisoning

• IV (10% sol): 0.3ml/kg (0.07mmol/kg)

Cardiac resuscitation

• IV (10% sol): 7-15ml (1.54-3.3mmol)

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The absolute amount of calcium required for this indication is difficult to determine and may vary widely

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Hypocalcaemic tetany

• IV (10% sol): Initial: 10ml (2.25mmol); Then: 40ml (9mmol), dly, administered as a continuous infusion

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Plasma calcium should be monitored

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Calcium-channel blocker overdose (additional agent required)
- Moderate cardiotoxicity

• IV (10% sol): 0.6ml/kg over 5min; Max dose: 30ml; Bolus doses can be repeated every 10-20min until 4 doses have been given OR infusion of 0.2ml/kg/hr; Max dose: 10ml/hr

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Calcium should be administered under ECG monitoring and calcium levels should be closely monitored

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Magnesium sulphate toxicity
- If respiratory depression occurs

• IV (10% sol): 10ml, infused slowly at a rate not >5min
  Refer to pre-eclampsia: STG, PHC 2018
  Refer to eclampsia: STG, PHC 2018

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See additional prescribing points for administration directions and precautions for use

Paed. forms avail. in SA and covered in this monograph: inj

Neonatal tetany

• IV (10% sol): 0.3ml/kg (0.07mmol/kg)

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Calcium gluconate injection is indicated for the treatment of neonatal tetany - it should not be routinely used in children <18 years of age

Pregnancy

• Caution
• Calcium passes across the placental barrier and its concentration in foetal blood is higher than in maternal blood
• Calcium gluconate injection should not be used during pregnancy unless the clinical condition of the woman requires treatment with calcium gluconate. The administered dose should be carefully calculated, and the serum calcium level regularly evaluated in order to avoid hypercalcaemia, which may be deleterious for the foetus

Breastfeeding

• Caution
• Calcium is excreted in breast milk. This should be borne in mind when administering calcium to women who are breastfeeding their infants
• A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from calcium gluconate injection therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

• No data available

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended
  Initiate at lower end of dosage range
• Severe: Contraindicated
  In patients with renal impairment, parenteral calcium should be administered only after careful assessment of the indication and the calcium-phosphate balance should be monitored

Hepatic Impairment

• Caution; no dose adjustment recommended
  Maintenance doses depend on blood calcium levels

Elderly

• Caution; no dose adjustment recommended 
  Although there is no evidence that the tolerance of calcium gluconate injection is directly affected by advanced age, factors that may sometimes be associated with ageing, such as impaired renal function and poor diet, may indirectly affect tolerance and may require a reduction in dosage. Renal function declines with age and prior to prescribing this product to elderly patients it should be considered that calcium gluconate injection is contraindicated for repeated or prolonged administration in patients with impaired renal function

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Non-regulated product
• Non-regulated products are not subjected to rigorous controls to verify its efficacy, safety, nor that the ingredients, dosages and claims listed on the label are indeed accurate, therefore authorities caution athletes against the risk of using these products

Cardiovascular Disorders 

• Bradycardia
• Cardiac arrhythmia
• Hypotension
• Vasodilatation
• Circulatory collapse (possibly fatal)
• Flushing

Gastrointestinal Disorders 

• Nausea and vomiting

Skin and Subcutaneous Tissue Disorders

• Heat sensations
• Sweating
• Calcinassi cutis
• Skin ablation
• Necrosis
• Extravasation
• Reddening of skin
• Burning sensation or pain

• Ceftriaxone
• Cardiac glycosides
• Digoxin
• Epinephrine
• Magnesium
• Calcium channel blockers
• Thiazide diuretics
• Vitamin D

Other

• Physical incompatibilities (See additional prescribing points)

• Serum calcium
• Vital signs
• Plasma albumin, phosphate and magnesium

Some cases may require

• ECG

Additional observations

• Infusion site

Injection - EML (Primary)

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Method of administration

• Infusion rate should not exceed 2ml/min (0.45mmol calcium/min)
• The patient should be in the lying position and should be closely observed during injection. Monitoring should include heart rate or ECG
• Calcium gluconate injection can be diluted with glucose 5% or sodium chloride 0.9%
• Avoid dilution into a solution containing bicarbonate, phosphate or sulfate

Precautions for use

• Solutions containing calcium should be administered slowly to minimise peripheral vasodilation and cardiac depression
• Intravenous injections should be accompanied by heart rate or ECG control because bradycardia with vasodilation or arrhythmia can occur when calcium is administered too quickly
• Plasma levels and urinary excretion of calcium should be monitored when high-dose parenteral calcium is administered
• Calcium salts are irritant. The infusion site must be monitored regularly to ensure extravasation injury has not occurred
• Patients receiving calcium salts should be monitored carefully to ensure maintenance of correct calcium balance without tissue deposition
• High vitamin D intake should be avoided

Patients receiving ceftriaxone

• Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than newborns, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products. In vitro studies demonstrated that newborns have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups
• In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions, even via different infusion lines or at different infusion sites
• However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation. Sequential infusions of ceftriaxone and calcium-containing products must be avoided in case of hypovolaemia

Incompatibilities

• Calcium salts can form complexes with many drugs, and this may result in a precipitate
• Calcium salts are incompatible with oxidising agents, citrates, soluble carbonates, bicarbonates, phosphates, tartrates and sulfates
• Physical incompatibility has also been reported with amphotericin, cephalothin sodium, cephazolin sodium, cephamandole nafate, ceftriaxone, novobiocin sodium, dobutamine hydrochloride, prochlorperazine and tetracyclines
• Care should be taken to avoid admixture of calcium gluconate and incompatible drugs in giving sets or in the circulation after separate administration
• Serious complications, including fatalities, have occurred following microcrystallisation of insoluble calcium salts in the body following separate administration of physically incompatible solutions or total parenteral nutrition solutions containing calcium and phosphate

Calcium is necessary for the functional integrity of nerves and muscles. It is essential for muscle contraction, cardiac function and blood coagulation. The normal concentration of calcium in plasma is within the range of 2.25 -2.75mmol or 4.5-5.5mEq per litre. The therapeutic effect of calcium substitution is normalisation of pathologically low serum calcium levels and thus relief of the symptoms of hypocalcaemia.

Calcium Gluconate is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

Injection (per 10ml) 902.5mg

• Calcium Gluconate Fresenius (Fresenius)