Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: hameln pharmaceuticals ltd, Gloucester, UK
Aluminium oxide can be leached from ampoule glass by Calcium Gluconate. In order to limit the exposure of patients to aluminium, especially those with impaired renal function and children (less than 18 years of age), hameln pharmaceuticals ltd Calcium Gluconate Injection BP is not intended for use in the preparation of Total Parenteral Nutrition (TPN).
Plasma calcium levels and calcium excretion should be monitored when calcium is administered parenterally, especially in children, in chronic renal failure or where there is 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, treatment should be discontinued immediately as cardiac arrhythmias may occur at these levels. Also see section 4.3.
Calcium salts should only be used with caution and after careful establishment of the indication in patients with nephrocalcinosis, heart diseases, sarcoidosis (Boeck’s disease), in patients receiving epinephrine (see section 4.5), or in the elderly.
Calcium gluconate is physically incompatible with many other compounds (see section 6.2). 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.
Renal impairment may be associated with hypercalcaemia and secondary hyperparathyroidism. Therefore, 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.
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. (see sections 4.3, 4.8, and 6.2). Sequential infusions of ceftriaxone and calcium-containing products must be avoided in case of hypovolaemia.
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 vasodilatation 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.
Cardiac glycosides: The effects of digoxin and other cardiac glycosides may be potentiated by calcium, which may result in serious toxicity. Therefore, intravenous administration of calcium preparations to patients under therapy with cardiac glycosides is contraindicated.
Epinephrine: Co-administration of calcium and epinephrine attenuate epinephrine’s β-adrenergic effects in postoperative heart surgery patients (see section 4.4).
Magnesium: Calcium and magnesium mutually antagonise their effects.
Calcium antagonists: Calcium may antagonise the effect of calcium antagonists (calcium channel blockers).
Thiazide diuretics: Combination with thiazide diuretics may induce hypercalcaemia as these medicinal products reduce renal calcium excretion.
Physical incompatibilities including interaction with ceftriaxone: See section 4.4 and section 6.2.
Calcium passes across the placental barrier and its concentration in foetal blood is higher than in maternal blood.
Calcium Gluconate Injection BP should not be used during pregnancy unless the clinical condition of the woman requires treatment with Calcium Gluconate Injection BP. 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.
Calcium is excreted in breast milk. This should be borne in mind when administering calcium to women who are breast-feeding their infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Calcium Gluconate Injection BP therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
No data available.
None.
The frequency of undesirable effects listed below is defined using the following convention: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1,000 to <1/100, Rare ≥1/10,000 to <1/1,000, Very rare <1/10,000, Not known Frequency cannot be estimated from the available data.
Cardiovascular and other systemic undesirable effects are likely to occur as symptoms of acute hypercalcaemia resulting from intravenous overdose or too rapid intravenous injection. Their occurrence and frequency is directly related to the administration rate and the administered dose.
Not known: Bradycardia, cardiac arrhythmia.
Not known: Hypotension, vasodilatation, circulatory collapse (possibly fatal), flushing, mainly after too rapid injection.
Not known: Nausea, vomiting.
Not known: Heat sensations, sweating.
Rarely, severe, and in some cases fatal, adverse reactions have been reported in preterm and full-term newborns (aged <28 days) who had been treated with intravenous ceftriaxone and calcium.
Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem. The high risk of precipitation in newborns is due to their low blood volume and the longer half-life of ceftriaxone compared with adults (see sections 4.3 and 4.4).
Not known: Calcinosis cutis, possibly followed by skin ablation and necrosis, due to extravasation, has been reported.
Reddening of skin, burning sensation or pain during intravenous injection may indicate accidental perivascular injection, which may lead to tissue necrosis.
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Calcium salts can form complexes with many drugs, and this may result in a precipitate (See section 4.4). 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.
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