EFFERVESCENT Uncoated tablets Ref.[7787] Active ingredients: Calcium gluconate

Posology

The tablets must be dissolved in one third to one half a tumblerful of water.

In health the concentration of calcium in serum is maintained close to 2.5mmol/l (normal range 2.25-2.75mmol or 4.5-5.5mEq/l).

Treatment or therapeutic supplementation should aim to restore or maintain this level.

Adults (including elderly)

Osteoporosis: A daily supplement of 800mg (20mmol) calcium or 8-9 tablets may reduce the rate of bone loss, but larger doses have not been shown to be more effective.

Children

Children require approximately half the adult dosage.

Infants

A more suitable dosage form should be used for this age group.

Method of Administration

To be dissolved in water for oral administration.

Deliberate overdosage is unlikely due to the large size of the tablets and the necessity to dissolve the tablets in water. The symptoms of overdosage with calcium include anorexia, lassitude, nausea, vomiting, headache, extreme thirst, vertigo, and raised blood urea; calcium may be deposited in many tissues including the kidney and arteries and the plasma cholesterol level may become elevated.

Calcium intake should be reduced to a minimum and any dehydration and electrolyte imbalance corrected immediately. A loop diuretic such as furosemide may be given to increase urinary calcium excretion. Drugs (such as thiazides and vitamin D compounds) which promote hypercalcaemia should be discontinued and dietary calcium should be restricted.

If severe hypercalcaemia persists, drugs which inhibit mobilisation of calcium from the skeleton may be required. The biophosphonates are useful and disodium pamidronate is probably the most effective. Plicamycin is probably the most rapidly effective drug but cannot be given continuously for more than a few days because of marrow toxicity; the duration of its hypocalcaemic effect is unpredictable but can last several days. Corticosteroids may only be useful where hypercalcaemia is due to sarcoidosis or vitamin D intoxication; they often take several days to achieve the desired effect. Calcitonin is relatively non-toxic but its effect can wear off after a few days despite continuous use; it is rarely effective where biophosphonates have failed to reduce serum calcium adequately. In severe cases, significant amounts of calcium may be removed by peritoneal dialysis.

Patients with symptoms of overdosage should avoid exposure to direct sunlight.

Special care must be exercised when treating overdosage in patients with impaired renal or hepatic function.

Shelf-life: Three years from the date of manufacture.

Shelf-life after dilution/reconstitution: Not applicable.

Shelf-life after first opening: Not applicable.

Store below 25°C in a dry place.

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.

Also included in each pack is a 2g silica gel capsule.

Pack sizes: 7s, 10s, 14s, 21s, 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Also included are 5 × 50g silica gel bags.

Maximum size of bulk packs: 5,000.

Not applicable.