Calcium-Sandoz injection

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.
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.