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Indications/Uses
The prevention and treatment of vitamin D deficiency.
As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.
As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.
Dosage/Direction for Use
Cholecalciferol (D-Vit 800) should be taken orally. The capsules should be swallowed whole (not chewed) with water. (See Table 1.)
Vitamin D3 is indicated for adults, the elderly and adolescents. Vitamin D3 should not be used in children under 12 years.
Missed Dose: If the patient misses a dose, just take the next dose and the subsequent doses at the usual recommended schedule. Do not double the dose.
Missed Dose: If the patient misses a dose, just take the next dose and the subsequent doses at the usual recommended schedule. Do not double the dose.
Overdosage
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.
If the patient has taken more than the recommended dosage, stop all intake of Vitamin D and rehydrate. Immediately consult a doctor or contact a Poison Control Center right away.
If the patient has taken more than the recommended dosage, stop all intake of Vitamin D and rehydrate. Immediately consult a doctor or contact a Poison Control Center right away.
Contraindications
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.
Special Precautions
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 cholecalciferol is not metabolised normally and other forms of vitamin D should be used. Caution is required in patients receiving treatment for cardiovascular disease.
Vitamin D3 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. Allowances should be made for vitamin D supplements from other sources. The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision. Medical supervision is required whilst on treatment to prevent hypercalcaemia. During long-term treatment with a daily dose exceeding 1,000 IU vitamin D, serum calcium values must be monitored. Vitamin D3 should not be given to children.
Consult a Doctor: If any undesirable effect occurs.
If the patient has taken more than the recommended dose.
If the patient is pregnant or think may be, or is planning to become pregnant, or is breastfeeding.
Effects on ability to drive and use machines: Vitamin D3 has no influence on the ability to drive and use machines.
Vitamin D3 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. Allowances should be made for vitamin D supplements from other sources. The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision. Medical supervision is required whilst on treatment to prevent hypercalcaemia. During long-term treatment with a daily dose exceeding 1,000 IU vitamin D, serum calcium values must be monitored. Vitamin D3 should not be given to children.
Consult a Doctor: If any undesirable effect occurs.
If the patient has taken more than the recommended dose.
If the patient is pregnant or think may be, or is planning to become pregnant, or is breastfeeding.
Effects on ability to drive and use machines: Vitamin D3 has no influence on the ability to drive and use machines.
Use In Pregnancy & Lactation
Pregnancy: There are no or limited amount of data from the use of cholecalciferol in pregnant women. Studies in animals have shown reproductive toxicity. 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.
Lactation: Vitamin D and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed, however, when prescribing additional vitamin D to a breast-fed child, the practitioner should consider the dose of any additional vitamin D given to the mother.
Lactation: Vitamin D and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed, however, when prescribing additional vitamin D to a breast-fed child, the practitioner should consider the dose of any additional vitamin D given to the mother.
Drug Interactions
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. The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium. 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.
Storage
Store at temperatures not exceeding 30°C.
Action
This product contains Cholecalciferol (Vitamin D3). In its biologically 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.
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 metabolite 1, 25 dihydroxycolecalciferol (calcitriol). The metabolites circulate in the blood bound to a specific α-globulin, Vitamin D and its metabolites are excreted mainly in the bile and faeces.
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 metabolite 1, 25 dihydroxycolecalciferol (calcitriol). The metabolites circulate in the blood bound to a specific α-globulin, Vitamin D and its metabolites are excreted mainly in the bile and faeces.
MedsGo Class
Vitamins A, D & E
Features
Brand
D-Vit 800
Full Details
Dosage Strength
800 IU
Drug Ingredients
- Vit. D
Drug Packaging
SoftGel Capsule 1's
Generic Name
Vit. D
Dosage Form
Softgel Capsule
Registration Number
DRP-8284
Drug Classification
Over-The-Counter (OTC)