Each soft capsule contains: Active ingredient: Vitamin D3 (Cholecalciferol) 5000 IU.
Excipients/Inactive Ingredients: Soybean oil, Gelatin, Concentrated glycerin, Purified water.
Pharmacotherapeutic group: Vitamin D and analogues. ATC code: A11CC05.
Pharmacology: Pharmacodynamics: In its biologically active form vitamin D3 stimulates intestinal calcium absorption, incorporation of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroid is inhibited directly by the biologically active form of vitamin D3. PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active vitamin D3.
Pharmacokinetics: Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile. It is hydroxylated in the liver to form 25-hydroxycolecalciferol and then undergoes further hydroxylation in the kidney to form active metabolite 1,25-hydroxycolecalciferol (calcitriol). The metabolites circulate in the blood bound to a specific α-globin. Vitamin D its metabolites are excreted mainly in the bile and feces.
Treatment and prevention of vitamin D deficiency states and hypocalcemia in disorders such as hypoparathyroidism.
Treatment of hypoparathyroidism in pregnancy.
Treatment of osteomalacia and rickets.
Treatment and prevention of osteoporosis (in conjunction with calcium).
Prevention of corticosteroid-induced osteoporosis.
Prevention of fractures.
Prevention of various cardiovascular, metabolic disorders including diabetes mellitus, multiple sclerosis and malignant disorders.
The usual dose is: See table.
Click on icon to see table/diagram/image
Method of administration: For oral administration.
The most serious consequences of acute or chronic overdose are hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdose can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of vitamin D and rehydration.
Hypersensitivity to the active substance or to any of the excipients listed (see Description).
If the patient has hypercalcemia.
Vitamin D should be used with cautions in infants, who may have increased sensitivity to its effects, and in patient with renal impairment or calculi, or heart disease, who might be at increased risk of organ damage if hypercalcemia occurred.
Plasma phosphate concentration should be controlled during vitamin D therapy due to the risk of ectopic calcification.
It is advised that patients receiving pharmacological doses of vitamin D should have their plasma calcium concentration monitored at regular intervals, especially initially or if symptoms suggests toxicity, and in infants if they are breast-fed by mothers receiving pharmacological doses of vitamin D.
Dose should be monitored by testing for serum vitamin D level.
Effects on the Ability To Drive and Operate Machine: Pacific Nature's Vitamin D3 5000 IU has no influence on the ability to drive or use machine.
Use in pregnancy: Hypercalcemia during pregnancy may produce congenital disorders in the offspring, and neonatal hypoparathyroidism. However, the risks to the fetus of untreated maternal hypoparathyroidism are considered greater than the risks of hypercalcemia due to vitamin D therapy.
Use in lactation: Vitamin D is distributed into breast milk, and its concentration appears to correlate with the amount of vitamin D in the serum of exclusively breast-fed infants. The American Academy of Pediatrics considers the use of vitamin D to be usually compatible with breast feeding, although they recommend, if the mother is taking pharmacological doses of vitamin D, that the infant be closely monitored for hypercalcemia or clinical manifestations of vitamin D toxicity.
Adverse reactions are listed as follows, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000).
Metabolism and nutrition disorders: Uncommon: Hypercalcaemia and hypercalciuria.
Skin and subcutaneous disorders: Rare: Pruritus, rash and urticaria.
*Any adverse drug reactions should be immediately reported to the physician or pharmacist.
Thiazide diuretics, calcium, or phosphate: Increased risk of hypercalcemia. Plasma calcium concentrations should be monitored.
Some antiepileptics (e.g., Carbamazepine, Phenobarbital, phenytoin, and primidone): Increased vitamin D requirements.
Rifampicin and isoniazid: Rifampicin and isoniazid may reduce the effectiveness of vitamin D.
Corticosteroids: Corticosteroids may counteract the effect of vitamin D.
Store in a cool dry place at room temperature not exceeding 30°C.
A11CC05 - colecalciferol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
Soft cap 5,000 IU x 10 x 10's.
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