CALCIFEROL OILY SOLUTION - LENNON
(and dosage form):
CALCIFEROL OILY SOLUTION - LENNON
Each mL of oily solution contains 0,125 mg of Calciferol.
(equivalent to: 5 000 IU of Vitamin D)
A 22.1.4 Vitamins - Other
Vitamin D is best characterised as a positive regulator of calcium homeostasis. Phosphate metabolism is affected by the vitamin in a manner parallel to that of calcium. The mechanism by which Vitamin D acts to maintain normal concentrations of calcium and phosphate in plasma are to facilitate their absorption by the small intestine, to interact with parathyroid hormone to enhance their mobilization from bone, and to decrease their excretion by the kidney.
Vitamin D is essential for normal calcification of bone. Normal bone formation occurs when calcium and phosphate concentrations in the plasma are adequate.
Vitamin D substances are well absorbed from the gastro intestinal tract. The presence of bile is essential for adequate intestinal absorption.
Absorbed Vitamin D circulates in the blood in association with Vitamin D - binding protein.
The vitamin disappears from the plasma with a half life of 19 to 25 hours but is stored in fat depots for prolonged periods. The primary route of excretion of Vitamin D is the bile.
Vitamin D and its metabolites undergo extensive enterohepatic recirculation.
For the treatment of nutritional rickets, the treatment of metabolic rickets and osteomalacia, and the treatment of hypoparathyroidism.
Hypersensitivity to any of the ingredients.
Vitamin D should not be administered to patients with hypercalcaemia.
It is advised that, if possible, women receiving pharmacological doses of Vitamin D do not breast feed their infants as this may lead to the development of hypercalcaemia in the infant.
Hypercalcaemia during pregnancy may produce congenital disorders in the off-spring and neonatal hypoparathyroidism.
The safety in pregnancy has not been established.
The effects of Vitamin D may be reduced in patients taking barbiturates or anticonvulsants.
DOSAGE AND DIRECTIONS FOR USE:
Shake the bottle before use.
For the treatment of nutritional rickets:
The minimum daily dose is 25 micrograms equivalent to 1000 units (0,2 mL ) but usually doses of 75 - 100 micrograms equivalent to 3 000 to 4 000 units (0,6 mL to 0,8 mL) daily are prescribed for rapid healing.
In the treatment of metabolic rickets and osteomalacia:
Doses of 0,25 - 1,25 mg equivalent to 10 000 to 50 000 units (2 mL - 10 mL) or more daily may be required.
In the treatment of hypoparathyroidism:
Doses of 1,25 to 2,50 mg equivalent to 50 000 to 100 000 units (10 mL - 20 mL) daily may be required.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Excessive intake of Vitamin D leads to the development of hypercalcaemia and its associated symptoms including hypercalciuria, ectopic calcification, and renal and cardiovascular damage.
Vitamin D should be administered with caution to infants as they may have increased sensitivity to its effects and should be used with care in patients with renal impairment or calculi, or heart disease, who might be at increased risk of organ damage if hypercalcaemia occurred.
Plasma phosphate concentrations should be controlled during Vitamin D therapy to reduce the risk of ectopic calcification.
Dietary supplementation with Vitamin D may be detrimental in persons already receiving an adequate intake through their diet and exposure to sunlight since the difference between therapeutic and toxic concentrations is relatively small.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Vitamin D is the most likely of all vitamins to cause overt toxicity. Infants and children are generally more susceptible to its toxic effects. The vitamin should be withdrawn if toxicity occurs. The initial signs and symptoms of toxicity are those associated with hypercalcaemia. Other signs include muscle weakness, apathy, headache, anorexia, nausea and vomiting, bone pain, ectopic calcification, proteinuria, hypertension and cardiac arrhythmias. Chronic hypercalcaemia can lead to generalised vascular calcification, nephrocalcinosis and rapid deterioration of renal function. Treatment of hypervitaminosis D consists of immediate withdrawal of the vitamin, a low calcium diet, administration of glucocorticoids, and vigorous fluid support.
A clear, bright oily solution.
Amber glass bottles of 15 mL.
Store below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
T1101 (Act 101/1965)
NAME AND ADDRESS OF APPLICANT:
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Harry's Printers K00000 J02
Updated on this site: February 2005
Source: Pharmaceutical Industry
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