About Vita D3®

Composition

Vita D3® 20000IU Capsule: Each capsule contains Cholecalciferol USP 20000IU. Vita D3® 40000IU Capsule: Each capsule contains Cholecalciferol USP 40000IU. Vita D3® 200000IU Injection: Each ampoule contains Cholecalciferol USP 200000IU.

Description

Vita D3® is a preparation of Cholecalciferol, a synthetic form of Vitamin D3. It is essential for normal bone growth and development and to maintain bone density. Cholecalciferol helps our body to utilize both Calcium and Phosphorus. It acts as a hormone and increases reabsorption of Calcium and Phosphorus by the kidneys.

Pharmacology

The active form of Vitamin D3, Calcitriol, exerts its effect by binding to the Vitamin D3 receptors (VDRs) which are widely distributed through many body tissues. Vitamin D3 has a half life of approximate-ly 50 days as it is fat soluble. Vitamin D3 is absorbed in the small intestine and bound to specific α-globulins and transported to the liver where it is metabolised to 25-hydroxy Vitamin D3 (Calcidiol). A second hydroxylation to 1, 25-dihydroxy Vitamin D3 (Calcitriol) occurs in the kidney. This metabolite is responsible for the vitamin's ability to increase the absorption of calcium. Non-metabolised Vitamin D3 is stored in tissues such as fat and muscle. Vitamin D3 is eliminated via faeces and urine.

Indications

Vitamin D3 deficiency can occur in people whose exposure to sunlight is limited and in those whose diet is deficient in Vitamin D3. Vitamin D3 is essential for the effective calcium and phosphate absorp-tion required for healthy bones and teeth, preventing rickets, osteomalacia and osteoporosis. High doses are also very effective in institutionalized or hospitalized patients. Vitamin D3 is important during pregnancy and breast-feeding as it is an essential nutrient for a growing infant.

Dosage and Administration

Oral Capsule

Adults

Treatment of Cholecalciferol deficiency: 40000 IU once every week for 7 weeks followed by 40000 IU each a month for 3 to 4 months or 20000 IU twice every week for 7 weeks followed by 20000 IU twice a month for 3 to 4 months. Follow-up 25(OH)D measurements should be made approximately 3 to 4 months after initiating maintenance therapy to confirm that the target level has been achieved.

Prevention of Cholecalciferol deficiency: 20000 IU every 4 weeks (1 capsule), higher doses may be required in certain populations..

Children

Treatment of Cholecalciferol deficiency (12-18 years): 20000 IU (1 capsule) once every 2 weeks for 6 weeks.

Prevention of Cholecalciferol deficiency (12-18 years): 20000 IU (1 capsule) every 6 weeks.

Intramuscular Injection

Prevention

Infants receiving Vitamin D enriched milk: 1/2 ampoule (0.5ml) i.e. 100000 IU every 6 months

Nursed infants or infants not receiving Vitamin D enriched milk or young children up to 5 years of age: 1 ampoule (1ml) i.e. 200000IU every 6 months.

Adolescents

1 ampoule (1mI) i.e. 200000 IU every 6 months.

Pregnancy

1/2 ampoule (0.5ml) i.e. 100000 IU from the 6th or 7th month of pregnancy.

Elderly

1/2 ampoule (0.5ml) i.e. 100000IU every 3 months.

Vitamin D Deficiency

1 ampoule (1ml) i.e. 200000IU which can be repeated once 1 to 6 months later.

Use in Pregnancy

Vitamin D3 is essential during pregnancy. But Vitamin D3 being fat soluble, high doses can be reached in the body tissue causing overdose and toxicity. So in case of pregnancy, such high doses shall be taken only with medical supervision .

Use in Lactation

Cholecalciferol and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed. Yet precaution should be taken by lactating mothers before taking high doses of Vitamin D3.

Use in Children & Adolescents

Cholecalciferol capsules should not be given to infants and children under the age of 12. Cholecalciferol injection can be given to infants.

Side effects

Symptoms rarely include anorexia, lassitude, nausea & vomiting, diarrhea, constipation, weight loss, polyuria, sweating, headache, thirst, vertigo and raised concentrations of calcium and phosphate in plasma and urine.

Warning & Precautions

Plasma-calcium concentration should be monitored at intervals in patients receiving high doses of Vitamin D3, in renal impairment, and during pregnancy & lactation. People using Digoxin and Thiazide Diuretics should consult a health care practitioner before supplementing with Vitamin D3. People with liver or kidney disease, primary hyperthyroidism, lymphoma, tuberculosis and granulomatous disease should consult a health care practitioner before supplementing with Vitamin D3. High doses of Vitamin D3 should be prescribed with caution to patients suffering from sarcoidosis.

Contraindications

Vitamin D3 is contraindicated in all diseases associated with hypercalcae- mia. It is also contraindicated in patients with known hypersensitivity to Vitamin D3 (or medicines of the same class) and any of the excipients. It is contraindicated if there is evidence of Vitamin D3 toxicity.

Drug Interactions

Antacids (Magnesium-containing), Phenytoin, Phenobarbital , Cholesty- ramine, Cholestipol, Digoxin, Thiazide Diuretics. Many drugs cause Vitamin D3 deficiencies because they interfere with the absorption and metabolism of Vitamin D3, and includes Cholestyramine , Cholistipol, Phenytoin, Phenobarbital , Orlistat , and Mineral Oil. Also, Corticos- teroids , such as Prednisolone increase the need for Vitamin D3.

Overdose

Being fat soluble, Vitamin D3 overdose can cause toxicity. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intakes of Vitamin D3 and rehydration.

Storage

Store in a cool and dry place, protected from light. Do not freeze. Keep out of reach of children.

Commercial Pack

Vita D3® 20000IU Capsule: Each box contains 2x5’s capsules in blister pack.

Vita D3® 40000IU Capsule: Each box contains 2x5’s capsules in blister pack.

Vita D3® 200000IU Injection: Each box contains 1 ampoule of 200000 IU.


Vitamin D, a Pro-Hormone which helps to maintain Calcium Level, Protec Bone & Immune

Vital Role of Vitamin D in Pregnancy

Modern life is Deprived from Sun-Light; Need Vitamin D

More that 80% have Vitamin D Deficiency. Vitamin D increases Calcium Absorption

Relation of Vitamin D Deficiency & other Complications.Vita D3 Sunshine for life.

Versatile functionality on of Vitamin-D3

Vita D3 Brand

Are you getting enough Vitamin D?

Vita D3 Sunshine for life

Manufactured by

RENATA LIMITED

Mirpur, Dhaka, Bangladesh
®Trade Mark
Upated: March, 2020
C-Code: 105214809/V02