Vit-D drops

Vitamin D₃.

Clear colorless to pale yellow oral solution.
1 ml of oral solution contains vitamin D3 (Colecalciferol) 800 IU.
Excipients/Inactive Ingredients: Medium-Chain Triglycerides.

Pharmacotherapeutic group: Vitamin D and analogues. ATC code: A11CC05.
Pharmacology: Pharmacodynamics: In its biological active form vitamin D3 stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release 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 parathyroids 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: The pharmacokinetics of vitamin D is well known. 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 the active metabolites circulate in the blood bound to a specific α-globin. Vitamin D and its metabolites are excreted mainly in the bile and faeces.
Toxicology: Preclinical safety data: Vitamin D is well known and is a widely used material and has been in clinical practice for many years. As such toxicity is only likely to occur in chronic overdosage where hypercalcaemia could result.
Colecalciferol has been shown to be teratogenic in high doses in animals (4-15 times the human dose). Offspring from pregnant rabbits treated with high dose of vitamin D had lesions anatomically similar to those of supravalvular aortic stenosis and offspring not showing such changing show vasculotoxicity similar to that of adults following acute vitamin D toxicity.

Prevention and treatment of vitamin D deficiency.

Pediatric: Prevention of vitamin D deficiency: 0.5 ml (400 IU) per day.
Treatment of vitamin D deficiency: 1 year and older: 2.5 ml (2000 IU) daily for 6 to 8 weeks to achieve serum 25(OH)D level greater than 20 ng/ml followed by 0.75-1.25 ml (600-1000 IU) daily.
Younger than 1 year: 2.5 ml (2000 IU) daily for 6 weeks to achieve serum 25(OH)D level greater than 20 ng/ml followed by 0.5-1.25 ml (400-1000 IU) daily.
Adult: Prevention of vitamin D deficiency: 2-2.5 ml (1600-2000 IU) per day.
Treatment of vitamin D deficiency: 7.5 ml (6000 IU) daily for 8 weeks to achieve serum 25(OH)D level greater than 30 ng/ml followed by 2-2.5 ml (1600-2000 IU) daily.
Elderly: Older than 70 years.
Recommended Daily Allowance: 800 IU per day.
Method of administration: Administer with syringe directly into mouth. See table.

Click on icon to see table/diagram/image

The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses 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 vitamin D or any of the excipients in the product.
Hypervitaminosis D.
Nephrolithiasis.
Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria.
Severe renal impairment.

Thai FDA mandatory warning: 1. This drug may accumulate in the body and may cause harm, therefore do not use over the limit dose or prolong use.
2. Use as directed by physician only.

Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolized normally and other forms of vitamin D should be used.
Caution is required in patients receiving treatment for cardiovascular disease.
Vit-D drops should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine.
Effects on ability to drive and use machines: Vit-D drops has no influence on the ability to drive and use machines.

There are no or limited amount of data from the use of colecalciferol in pregnant women. Studies in animals have shown reproductive toxicity. However, the risks to the mother and fetus from untreated hypoparathyroidism or hypophosphatemia may be greater than those resulting from administration of vitamin D analogs. Large doses of vitamin D analogs should not be administered to nursing women.
The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be vitamin D deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment.
During lactation, small and probably unimportant amounts of maternal circulating vitamin D and its metabolites are distributed into breast milk. Evidence from randomized controlled studies and observational data indicate that increased maternal intake of vitamin D has no effect on neonatal excessive.

Hypercalcaemia and hypercalciuria, headache, nausea, vomiting, weakness, cardiac arrhythmias, pruritus, rash and urticaria.

Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D.
Concurrent use of vitamin D analogs and cardiac glycosides may result in cardiac arrhythmias.
Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.
The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.

Incompatibilities: Not applicable.

Store below 30°C.
Shelf life: 24 months.
Once opened use within 1 month.

Vitamins A, D & E

A11CC05 - colecalciferol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.

D