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 Metocal® VIT D3
Calcium carbonate 1500 mg (equivalent to 600 mg of elemental calcium) +
Cholecalciferol 400 I.U.
Chewable tablets
COMPOSITION
One chewable tablet contains:
Active substances:
1500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and
4 mg of cholecalciferol concentrate (equivalent to 400 U.I. of vitamin D,).
Excipients:
Xylitol, mannitol, magnesium stearate, silica colloidal anhydrous,
pregelatinised starch, butylated hydroxytoluene (E321), medium-chain
triglycerides, sucrose, gelatin, modified starch, sodium aluminium silicate,
flavouring agents.
PHARMACEUTICAL FORM
Chewable tablets.
White biplane tablets with a snap grove and the letter C/D.
THERAPEUTIC CATEGORY (ATC CODE)
A12AX: Vitamin-mineral combinations.
PHARMACODYNAMIC PROPERTIES
METOCAL VIT D, chewable tablets are a vitamin-mineral combination.
Vitamin D supplementation corrects an insufficient vitamin D intake. It
increases the intestinal absorption of calcium. The optimal vitamin D dose
in elderly subjects is 500 - 1000 I.U. per day. Calcium supplementation
balances a dietary calcium deficiency. The usual calcium requirement of the
elderly is 1500 mg/day. Vitamin D and calcium supplementation correct
secondary senile hyperparathyroidism.
In a double-blind placebo controlled study of 18 months, including 3270
women aged 84±6 and living in nursing homes, supplemented with cholecalciferol (800 I.U./day) + calcium (1.2 g/day), a significant decrease
in PTH secretion has been observed. After 18 months, the results of the
intent to treat analysis showed 80 hip fractures (5.7%) in the calcium
vitamin D group and 110 hip fractures (7.9%) in the placebo group (p=0.004).
So in the conditions of this study, the treatment of 1387 women prevented 30
hip fractures.
After 36 months of follow-up, 137 women presented at least one hip fracture
(11.6%) in the calcium vitamin D3 group (n=1176) and 178 (15.8%) in the
placebo group (n=1127) (p≤0.02).
PHARMACOKINETIC PROPERTIES
Calcium carbonate
Calcium carbonate releases, pH-dependently, calcium ions in the stomach.
Calcium administered as calcium carbonate is absorbed from 20 to 30%. The
uptake takes place mainly in the duodenum through a vitamin D-dependent,
saturable, active transport. Calcium is excreted with the urine, faeces and
perspiration. The excretion of calcium in the urine depends on the
glomerular filtration and tubular reabsorption of calcium.
Vitamin D
Vitamin D is absorbed in the small intestine and bound to specific alpha
globulins, and is transported to the liver where it is metabolised into
25-hydroxy-cholecalciferol. A second hydroxylation to
1,25-dihydroxy-cholecalciferol takes place in the kidneys. This metabolite
is responsible for the effect of vitamin D, i.e. increase of calcium
absorption. Non-metabolised vitamin D is stored in tissues, e.g. in fat and
muscle. Vitamin D is excreted by the faeces.
INDICATIONS
Correction of combined Vitamin D and calcium deficiencies in the elderly.
Vitamin D and calcium supplementation as an adjunct to specific treatment
for osteoporosis in patients, where combined vitamin D and calcium
deficiencies have been diagnosed or at a high risk of such deficiencies.
CONTRAINDICATIONS
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Hypercalcaemia, hypercalciuria
- Kidney stones
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Long-term immobilisation in combination with hypercalciuria and/or
hypercalcaemia
-
Nephrocalcinosis
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Primary hyperparathyroidism
- Vitamin D overdose
- Myeloma
-
Bone metastases
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Hypersensitivity to the active substances or to any of the excipients
PRECAUTIONS FOR USE
During prolonged treatment with METOCAL VIT D, chewable tablets the calcium
levels in serum and urine should be monitored, and the renal function should
be controlled by measuring serum creatinine. This control is particularly
important in elderly patients and during concomitant treatment with cardiac
glycosides and diuretics. In the event of hypercalcaemia or signs of
impaired renal function the dose must be reduced or the treatment
interrupted. It is advisable to reduce the dose or interrupt the treatment
if urinary calcium level exceeds 7.5 mmol/24 hours (300 mg/24 hours).
Special care is required on concurrent treatment with bisphosphonates,
sodium fluoride or tetracycline (see 4.5 Interactions).
Take into account the vitamin D dose when prescribing other medicinal
products containing vitamin D. An additional administration of vitamin D or
calcium should take place under medical supervision. In such cases the
calcium levels in plasma and urine must be monitored.
METOCAL VIT D3 chewable tablets should be prescribed with caution in
patients with sarcoidosis, since there is the risk of increased conversion
of vitamin D into its active metabolite. In these patients the calcium
levels in plasma and in urine should be monitored.
Patients with renal insufficiency have an altered vitamin D metabolism. If
they are treated with cholecalciferol the effects on calcium and phosphate
turnover should be monitored.
METOCAL VIT D, chewable tablets contain Sucrose and therefore should not be
used by patients with rare hereditary problems of fructose intolerance,
glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Note for diabetics:
The proportion of digestible carbohydrate in METOCAL VIT D,
chewable tablets is 0.47 g per tablet. The daily dose of 2 tablets
corresponds to 0.08 carbohydrate units (CU).
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