CALCIFEROL OILY SOLUTION - LENNON
SCHEDULING STATUS:
S3
PROPRIETARY NAME
(and dosage form):
CALCIFEROL OILY SOLUTION - LENNON
COMPOSITION:
EachmL of oily solution contains 0,125mg of Calciferol.
(equivalent to: 5000 IU of VitaminD)
PHARMACOLOGICAL CLASSIFICATION:
A 22.1.4 Vitamins - Other
PHARMACOLOGICAL ACTION:
VitaminD 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 VitaminD 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.
VitaminD is essential for normal calcification of bone. Normal bone formation occurs when calcium and phosphate concentrations in the plasma are adequate.
VitaminD substances are well absorbed from the gastro intestinal tract. The presence of bile is essential for adequate intestinal absorption.
Absorbed VitaminD circulates in the blood in association with VitaminD - binding protein.
The vitamin disappears from the plasma with a half life of 19 to 25hours but is stored in fat depots for prolonged periods. The primary route of excretion of VitaminD is the bile.
VitaminD and its metabolites undergo extensive enterohepatic recirculation.
INDICATIONS:
For the treatment of nutritional rickets, the treatment of metabolic rickets and osteomalacia, and the treatment of hypoparathyroidism.
CONTRA INDICATIONS:
Hypersensitivity to any of the ingredients.
VitaminD should not be administered to patients with hypercalcaemia.
It is advised that, if possible, women receiving pharmacological doses of VitaminD 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.
WARNINGS:
The safety in pregnancy has not been established.
The effects of VitaminD 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 25micrograms equivalent to 1000units (0,2mL ) but usually doses of 75 - 100micrograms equivalent to 3000 to 4000 units (0,6mL to 0,8mL) daily are prescribed for rapid healing.
In the treatment of metabolic rickets and osteomalacia:
Doses of 0,25 - 1,25mg equivalent to 10000 to 50000 units (2mL - 10mL) or more daily may be required.
In the treatment of hypoparathyroidism:
Doses of 1,25 to 2,50mg equivalent to 50000 to 100000 units (10mL - 20mL) daily may be required.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Excessive intake of VitaminD leads to the development of hypercalcaemia and its associated symptoms including hypercalciuria, ectopic calcification, and renal and cardiovascular damage.
VitaminD 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 VitaminD therapy to reduce the risk of ectopic calcification.
Dietary supplementation with VitaminD 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:
VitaminD 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 hypervitaminosisD consists of immediate withdrawal of the vitamin, a low calcium diet, administration of glucocorticoids, and vigorous fluid support.
IDENTIFICATION:
A clear, bright oily solution.
PRESENTATION:
Amber glass bottles of 15mL.
STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
APPLICATION NUMBER:
T1101 (Act 101/1965)
NAME AND ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH
6020
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
26/08/1985
308530 020927
Harry's Printers K00000 J02
Updated on this site: February 2005
Source: Pharmaceutical Industry |
