Download Calcium-Sandoz®10%

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