Calcium Lactate Tablets 300mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcium Lactate Tablets 300mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Lactate 300mg.
3. PHARMACEUTICAL FORM
Tablet.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Prevention and treatment of calcium deficiency; osteoporosis, osteomalacia, rickets, post gastrectomy malabsorption, pregnancy and lactation.
4.2. Posology and method of administration
Adults.
Osteoporosis, osteomalacia, rickets, post gastrectomy malabsorption and as a supplement in pregnancy and lactation.
Up to 20 tablets daily in divided doses.
Children 6-12 years Up to 10 tablets daily.
Route of administration.
Oral.
4.3.
Contraindications
Conditions associated with hypercalcaemia and hypercalciuria: patients with a history of renal calculi, cardiac disease and sarcoidosis.
4.4. Special warnings and precautions for use
If given to patients with renal impairment frequent monitoring of serum calcium is recommended.
4.5. Interactions with other medicinal products and other forms of interaction
Calcium salts reduce adsorption of tetracyclines and biphosphonates. Thiazide diuretics can increase the risk of hypercalcaemia so should not be given in conditions where they could enhance potential digoxin toxicity.
4.6. Pregnancy and lactation
Epidemiological studies have shown no increase in teratological or other hazards to the foetus when used in recommended dosage during pregnancy and breast feeding.
4.7. Effects on ability to drive and use machines
1. May cause mild gastrointestinal disorders, especially constipation
4.8. Undesirable effects
1. Large doses of ascorbic acid are reported to cause diarrhoea and other gastrointestinal disturbances and are associated with renal calcium oxalate calculi. Ascorbic acid should be given with care to patients with hyperoxaluria
2. There is a report of an allergic reaction to ascorbic acid in 3 patients presenting as eczema, uticaria or asthma.
4.9. Overdose
Excessive intake may lead to symptoms of hypercalcaemia which include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbance, polydipsia, polyuria, bone pain, nephrooalcinosis, renal calculi, and in severe cases cardiac arrhythms and coma. Following oral administration these effects are most likely to occur in patients with renal failure. Treatment is by oral rehydration and administration of loop diuretics to increase calcium excretion. Thiazide diuretics should be avoided if these measures are unsuccessful. Other drugs such as calcitonins, the biphosphonates and plicamycin may be tried. As a last resort haemodialysis may be considered.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Calcium is the most abundant mineral in the body and is an essential electrolyte. Homeostasis is mainly regulated by the parathyroid hormone, by calcitonins and by vitamin D. The body contains about 350 to 500 mmol of calcium per kg of body weight, about 99% being in the skeleton. Normal concentrations of calcium in the plasma are between 2.2 and 2.6 mmol per litre. Intercellular calcium concentrations range from 0.1 to 1 micromole per litre.
5.2. Pharmacokinetic properties
Calcium is adsorbed from the small intestine, the amount being dependant on dietary and physiological factors. More is adsorbed during periods of increased need e.g. pregnancy and lactation. Most adsorbed calcium is eventually deposited in skeletal tissue the remainder being present in both intra and extra cellular fluids. About half the blood calcium is in ionised form with five percent complexed in citrate, phosphate and other anion and the rest protein bound.
Calcium is excreted in the urine although a large amount undergoes renal readsorption. Excretion also occurs in the faeces, both unabsorbed material and that excreted in bile and pancreatic juice. Small amounts are lost in sweat Calcium crosses the placenta and is excreted in breast milk
5.3. Preclinical safety data
No relevant data
6.
PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Starch.
Povidone 30.
Liquid Paraffin.
Talc.
Stearic Acid.
Industrial Methylated Spirits (not detected)
6.2. Incompatibilities
None.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
None.
6.5. Nature and contents of container
Polypropylene securitainers or high density polyethylene pails. Pack size 1000 tablets.
6.6 Instructions for use/handling
None.
7. MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Ltd Head Office Address
Samuel Ryder House Townsend Drive Nuneaton CV11 6XW
8. MARKETING AUTHORISATION NUMBER(S)
PL 14010/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/01/2005
10 DATE OF REVISION OF THE TEXT
05/01/2005