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Calcium-Sandoz 10% ® Ampoules For parenteral calcium therapy Composition One ampoule (10 ml injectable solution) contains: 1.375 g calcium glubionate, equivalent to 90 mg ionizable calcium (or a 10% solution of calcium gluconate); water to 10 ml. Properties / Actions Parenteral administration of Calcium-Sandoz rapidly reverses acute hypocalcaemia and its clinical symptoms, which may include paraesthesia, laryngospasm, muscular spasms, and increased neuromuscular excitability leading to tetany and convulsions. In patients with chronic calcium deficiency states caused by intestinal malabsorption, parenteral calcium therapy restores and maintains normal calcium metabolism. Because of its good tissue tolerance, calcium glubionate is suitable not only for intravenous but also for deep intramuscular injection (except in children). Pharmacokinetics Absorption following intravenous or intramuscular injection When administered by i.m. injection calcium salts are rapidly absorbed and distributed to the vascular compartment. Following both i.v. and i.m. administration the calcium ions divide into a diffusible and non-diffusible fraction. Serum calcium is briefly raised immediately after administration but returns to normal within 30-120 minutes as a result of homeostatic regulation. Distribution Homeostasis ensures that the calcium concentration in the blood is regulated within narrow limits, i.e. 2.15-2.55 mmol/l (85-105 mg/l), or 1.13-1.32 mmol/l (45-55 mg/l) for ionized calcium (active fraction) (reference ranges in serum). Approx. 46% of total blood calcium is bound to albumin and globulins (non-diffusible), 47% is in ionized form (diffusible) and the remaining 7% is complexed to organic acids (diffusible). Over 98% (ε1200 g) of the body’s calcium content is stored in skeletal tissue. Distribution of calcium entering the system is governed primarily by calcitonin and parathyroid hormone, although 1,25-dihydroxycholecalciferol (vitamin D) is also involved in bone mineralization and bone resorption. Elimination Excretion or loss of calcium is primarily in the faeces via the bile and pancreatic juice. In healthy adults 24-hour urinary excretion normally amounts to 150-250 mg. Indications / Uses Calcium deficiency states such as hypocalcaemia, hypocalcaemic tetany, rickets, osteomalacia, and osteoporosis resulting from intestinal malabsorption or disturbed calcium metabolism. Lead, arsenic, carbon tetrachloride, phosgene or potassium poisoning. Dosage / Administration Usual dose range Adults: 10 ml i.v. or i.m. 1-3 times daily. Children: 5-10 ml i.v. once daily. Warm solutions to body temperature and give slowly (0.5-2 ml/min); stop if patient complains of discomfort. Resume when symptoms disappear. Following injection, patient should remain recumbent for a short time. Repeated injections may be needed because of the rapid calcium excretion. Administration by intravenous drip infusion is recommended in cases of severe hypocalcaemia (for adults as well as children), with dose determination on the basis of calcium blood and urinary excretion levels. Infants and young children with severe hypocalcaemia should normally be given 40-80 mg ionizable calcium (4-9 ml injectable solution) per kg bodyweight by i.v. infusion every 24 hours for a maximum of 3 days, with concomitant vitamin D if indicated. The pulse rate should be monitored during administration and should a bradycardia develop, the intravenous infusion should be stopped immediately. Follow-up treatment should be by the oral route. Restriction on use Contraindications Hypersensitivity to the drug; hypercalcaemia and severe hypercalciuria (e.g. in hyperparathyroidism, vitamin-D overdosage, decalcifying tumours such as plasmocytomas or bone metastases, or immobilization osteoporosis); severe renal failure; galactosaemia; ventricular fibrillation. Parenteral calcium is strictly contraindicated in patients receiving digitalis or adrenaline. Precautions Parenteral administration of high doses of calcium should always be accompanied by close monitoring of blood and urine levels, particularly in children, and treatment discontinued at once if blood calcium exceeds 2.625 mmol (105-110 mg/l) or 24 hour urinary excretion is higher than 0.125 mmol (5 mg/kg). Cardiovascular effects: It is particularly important to prevent a high concentration of calcium from reaching the heart because of the danger of cardiac syncope. ECG monitoring is indicated in patients receiving calcium by i.v. infusion for the treatment of severe hyperkalaemia. Injectable calcium solutions (including Calcium-Sandoz) have been found to contain small amounts of aluminium (up to 5 mg/l). Prolonged use in neonates, infants and patients with severely impaired renal function should therefore be avoided as it may lead to aluminium accumulation with the possibility of skeletal, neurological or haematological disturbances. Pregnancy and lactation Pregnancy category C1. There have been no controlled studies with parenteral Calcium-Sandoz in either animals or pregnant woman and it should only be given by this route during pregnancy if absolutely necessary or for short periods to combat deficiency states. Lactation: it is not known whether calcium glucobionate is excreted in breast milk. Exercise caution when administering to a lactating woman. Adverse reactions Nausea, vomiting, hot flushes, sweating, hypotension, bradycardia, sense of oppression, tingling, metallic, calcium or chalky taste, cardiac arrhythmia and even sudden circulatory failure may be caused by too rapid i.v. injection. Interactions Calcium enhances the effects of digitalis glycosides on the heart (see Contraindications); the response to verapamil and possible other calcium antagonists may be reduced. Thiazide diuretics: Hypercalcemia resulting from renal tubular reabsorption, or bone release of calcium by thiazides may be amplified by exogenous calcium. Atenolol: Mean peak plasma levels and bioavailability of atenolol may be decreased, possibly resulting in decreased beta blockade. Sodium polystyrene sulfonate: Coadministration in patients with renal impairment may result in an unanticipated metabolic alkalosis and a reduction of the resin’s binding of potassium. Drug/Lab test interactions: Transient elevations of plasma 11-hydroxycorticosteroid levels (Glenn-Nelson technique) may occur when IV calcium is administered, but levels return to control values after 1 hour in addition. Overdosage The symptoms are those of hypercalcaemia: loss of appetite, nausea, vomiting, constipation, abdominal pain, muscle weakness, polyuria, thirst, drowsiness and confusion, with coma, cardiac arrhythmia and cardiac arrest in severe cases. Management involves measures to reduce the calcium blood level, e.g. sodium phosphate by mouth or, in severe cases, i.v. infusion. It is now agreed the most effective therapy is IV sodium chloride infusion plus potent natriuretic agents (e.g. furosemide). Sodium competes with calcium for reabsorption in the distal renal tubule and furosemide potentiates this effect. Together they markedly increase renal calcium clearance and reduce hypercalcaemia. Other information General Intravenous injections should be given slowly (3 minutes per 10 ml) and cardiac rhythm monitored throughout. Injections by the intramuscular route, which should not be used in children, should be given deep into the gluteal muscle. Calcium-Sandoz should not be injected subcutaneously. Calcium-Sandoz should be kept out of reach of children. Shelf-life Not to be used after the expiry date (= EXP) printed on the pack. Pack sizes Packs of 5 or 100 ampoules of 10 ml Information correct at October 1992 Manufacturer Novartis Pharma AG, Switzerland for Novartis Consumer Health SA Nyon Switzerland Registration Owner NCH Ltd, Basel 25, Petach-Tikva IL 890515 2021775 IL