Vital-D Capsule 1000IU

Product Information

VITAL-D

Vital®-D 1000 IU, 2000 IU, 20000 IU & 40000 IU

Cholecalciferol

Presentation

Vital-D 1000 IU softgel capsule: Bicolor (Transparent light yellow & opaque deep yellow), oval shaped softgel capsule; each

capsule contains Cholecalciferol USP 1000 IU.

Vital-D 2000 IU softgel capsule: Bicolor (Opaque deep orange & opaque deep yellow), oval shaped softgel capsule; each capsule

contains Cholecalciferol USP 2000 IU.

Vital-D 20,000 IU softgel capsule: Bicolor (Transparent orange & opaque deep brown), oval shaped softgel capsule; each capsule

contains Cholecalciferol USP 20,000 IU.

Vital-D 40,000 IU softgel capsule: Bicolor (Transparent deep orange & opaque deep brown), oval shaped softgel capsule; each

capsule contains Cholecalciferol USP 40,000 IU.

Indications

Vital-D softgel capsules (Cholecalciferol) are indicated for the treatment and prevention 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.

Dosage and administration

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Children: Vital-D softgel capsules (Cholecalciferol) are not recommended for children under 12 years due to the risk of choking

Certain populations: Certain populations are at high risk of Vitamin-D deficiency, and may require higher doses and monitoring of

serum 25(OH)D:  institutionalised or hospitalised individuals, dark skinned individuals, individuals with limited effective sun

exposure due to protective clothing or consistent use of sun screens, patients being evaluated for osteoporosis, obese

individuals, use of certain concomitant medications (e.g. anticonvulsant medications glucocorticoids, anti-retrovirals), those

recently treated for Vitamin-D deficiency, and requiring maintenance therapy, patients with liver or renal disease, patients with

malabsorption, including inflammatory bowel disease and coeliac disease.

Contra-indications, warnings etc.

Contra-indications: Cholecalciferol softgel capsules must not be used in patients with hypersensitivity, hypercalcaemia and/or

hypercalciuria, nephrolithiasis, hypervitaminosis & severe renal impairment.

Warnings and precautions: Cholecalciferol softgel capsules 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. Cholecalciferol should not be taken by patients with a tendency to form

calcium-containing renal calculi. Caution is required in patients receiving treatment for cardiovascular disease. Cholecalciferol

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. 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.

Drug interactions: Phosphate infusions should not be administered to lower hypercalcaemia of hypervitaminosis D because of the

dangers of metastatic calcification. Patients treated with cardiac glycosides may be susceptible to high calcium levels and should

have ECG parameters and calcium levels monitored. It is recommended to reduce the dose or interrupt treatment if the calcium

content in the urine exceeds 7.5 mmol/24 hours (300 mg/24 hours). Simultaneous administration of benzothiadiazine derivatives

(thiazide diuretics) increases the risk of hypercalcaemia because they decrease the calcium excretion in the urine. The calcium

levels in plasma and urine should therefore be monitored for patients undergoing long-term treatment. If Cholecalciferol is

combined with metabolites or analogues of Vitamin-D careful monitoring of serum calcium levels is recommended. Anti-convulsants

e.g. phenytoin, phenobarbital, primidone may diminish the effect of Cholecalciferol due to hepatic enzyme induction. Rifampicin

may reduce the effectiveness of Cholecalciferol due to hepatic enzyme induction. Isoniazid may reduce the effectiveness of

Cholecalciferol due to inhibition of the metabolic activation of Cholecalciferol. Drugs leading to fat malabsorption, e.g.

orlistat, liquid paraffin, cholestyramine, may impair the absorption of Cholecalciferol. 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. Concomitant use of glucocorticoids can decrease

the effect of Vitamin-D.

Use in pregnancy and lactation: Studies have shown safe use of doses up to 4000IU during pregnancy. 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. 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.

Effects on ability to drive and use machines: No studies on the effects on the ability to drive or use machines have been

performed. Cholecalciferol has no known side effects that are likely to affect the ability to drive and use or operate machines

Side-effects: Adverse reactions are listed below, by system organ class and frequency

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Overdose: Acute or chronic overdose of Cholecalciferol can cause hypercalcaemia, an increase in the serum and urinary

concentrations of calcium. The symptoms of hypercalcaemia are not very specific and consist of nausea, vomiting, diarrhoea often

in the early stages and later constipation, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, polydipsia,

polyuria formation of renal calculi, nephrocalcinosis, kidney failure, calcification of soft tissues, changes in ECG measurements,

arrhythmias and pancreatitis. In rare and isolated cases there are reports that hypercalcaemia is fatal.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Vital-D 1000 IU softgel capsule: Cartons containing 30 softgel capsules in Alu-PVDC blister.

Vital-D 2000 IU softgel capsule: Cartons containing 30 softgel capsules in Alu-PVDC blister.

Vital-D 20,000 IU softgel capsule: Cartons containing 10 softgel capsules in Alu-PVDC blister.

Vital-D 40,000 IU softgel capsule: Cartons containing 10 softgel capsules in Alu-PVDC blister.

Manufactured by

UniMed UniHealth Pharmaceuticals Limited

B K Bari, Gazipur, Bangladesh

®Registered Trademark