S O M A T E C

About Us

SOMATEC PHARMACEUTICALS LTD. is a fast growing pharmaceutical company in Bangladesh.

Contact Info

28/B, Segun Bagicha, Dhaka-1000, Bangladesh.

+880-02-9337667

+880-02-9357827

+880-02-8391480

info@somatecpharmabd.com

D-High

Viiamin D3 is produced when sunlight converts cholesterol in the skin into a form of Vitamin D3 called calciol. Then the liver hydroxylates calciol into a form called calcidiol (25-hydroxy Vitamin D3). The kidneys then hydroxylate calcidiol into the active form of Vitamin D3 called calcitriol (1,25-dihydroxy Vitamin D3), which acts as a hormone. Calcidiol, the inactive form of Vitamin D3 is circulated and stored in the body. Virtually every cell in the human body has receptors of Vitamin D3 because it is not just a Vitamin, but also a hormone. As a hormone, it controls phosphorus, calcium, bone metabolism and neuromuscular functions. Ultimately it regulates cellular production of important proteins and peptides. Vitamin D3 also affects the expression of many genes, including ones that are key factors in the development of cancer.

Brand Name

: D-High

Generic Name

: Cholecalciferol

Therapeutic Class

: Vitamin & Mineral

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 absorption required for healthy bones and teeth, preventing Rickets, Osteomalacia and Osteoporosis. Vitamin D3 is important during pregnancy and breast-feeding, an essential nutrient for a growing infant. lt is also essential to prevent pre-eclampsia during pregnancy. Vitamin D supplements in prediabetes reduces progression of type-2 diabetes.

Pharmacology

The active form of Vitamin D3 calcitriol, exerts its effect by binding to the Vitamin D receptors (VDRs) which are widely distributed through many body tissues. Vitamin D3 is absorbed in the small intestine which bound to specific 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 (catcitriol) occurs in the kidney. This metabolite is responsible for the vitamins 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.

Dosage

For Capsule:
Adults:
Treatment of Cholecalciferol deficiency: 40,000 lU/week for 7 weeks, followed by maintenance therapy (1400-2000 lU/day)
Prevention of Vitamin D deficiency: 20,000 lU/month.
Children (12-18 years):
Treatment of Vitamin D deficiency: 20,000 lU, once every 2 weeks for 6 weeks.
Prevention of Vitamin D deliciency: 20,000 lU, once every 6 weeks.
OR AS DIRECTED BY THE PHYSICIAN.

Interaction

Vitamin D3 interacts with antacids (magnesium-containing), phenytoin, phenobarbital, cholestyrarmine, cholestipol, digoxin, thiazide diuretics. Many drugs cause vitamin D3 deficiencies because they interfere with the absorption and metabolism of Vitamin D3 and includes cholestyramine, cholestipol, phenytoin, phenobarbital, orlistat and mineral oil. Also, corticosteroids, such as prednisolone increase the need for Vitamin D3. Cholecalciferol is known to interact with Carbamazepine, Dactinomycin, Diuretics, Fosphenytoin, Micanazole, Phenobarbital, Phenytoin, Primidone.

Contraindications

Vitamin D3 is contraindicated in all diseases associated with hypercalcaemia. It is also contraindicated in patients with known hypersensitivity to Vitamin D3 or any of the components of the products. It is also contraindicated in Severe Renal Impairment, Hypervitaminosis D and Nephrolithiasis.

Side Effects

Occasional acute symptoms including anorexia, lassitude, nausea, vomiting, diarrhea, constipation, weight loss, polyuria, sweating, headache, thirst, vertigo, and raised concentrations of calcium and phosphate in plasma and urine.

Pregnancy & Lactation

Pregnancy: Vitamin D3 demand increases during pregnancy. Vitamin D3 deficiency during pregnancy can affect bone development and immune function from birth through adulthood. Low Vitamin D3 levels are common among those taking a standard prenatal multivitamin, which usually contains 400 lU, but  inadequate for pregnant women. Even 800 IU of vitamin D3, per day didn't permit most pregnant women to reach a normal vitamin D3 level. A recently completed study funded by the national institutes of Health tested the safety and effectiveness of 4000 IU vitamin D3 per day in pregnant women. The researchers reported that this dose was safe and effective in achieving normal vitamin D3 levels and resulted in fewer pregnancy complications (infections, preterm labor, birth, and pre-eclampsia) when compared with 400 lU Vitamin D3 per day.
Lactation: It should be assumed that exogenous vitamin D3 passes into the breast milk. In view of the potential for hypercalcaemia in the mother and for adverse reactions from vitamin D3 in nursing infants, mothers may breastfeed while taking vitamin D3, provided that the serum calcium levels of the mother and infant are monitored. The American Academy of Pediatrics (AAP) currently recommends that breastfeed infants receiving a supplement of vitamin D3 every day prevent Vitamin D3 deficiency and rickets.

Precautions & Warnings

Plasma-calcium concentration should be monitored at intervals in patients receiving high doses of Vitamin D3 in renal impairment, 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.

Storage Conditions

· Store in dry place & protected from light.
· Keep storage within 250 C. temperature.

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 absorption required for healthy bones and teeth, preventing Rickets, Osteomalacia and Osteoporosis. Vitamin D3 is important during pregnancy and breast-feeding, an essential nutrient for a growing infant. lt is also essential to prevent pre-eclampsia during pregnancy. Vitamin D supplements in prediabetes reduces progression of type-2 diabetes.

Pharmacology

The active form of Vitamin D3 calcitriol, exerts its effect by binding to the Vitamin D receptors (VDRs) which are widely distributed through many body tissues. Vitamin D3 is absorbed in the small intestine which bound to specific 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 (catcitriol) occurs in the kidney. This metabolite is responsible for the vitamins 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.

Dosage

For Capsule:
Adults:
Treatment of Cholecalciferol deficiency: 40,000 lU/week for 7 weeks, followed by maintenance therapy (1400-2000 lU/day)
Prevention of Vitamin D deficiency: 20,000 lU/month.
Children (12-18 years):
Treatment of Vitamin D deficiency: 20,000 lU, once every 2 weeks for 6 weeks.
Prevention of Vitamin D deliciency: 20,000 lU, once every 6 weeks.
OR AS DIRECTED BY THE PHYSICIAN.

Interaction

Vitamin D3 interacts with antacids (magnesium-containing), phenytoin, phenobarbital, cholestyrarmine, cholestipol, digoxin, thiazide diuretics. Many drugs cause vitamin D3 deficiencies because they interfere with the absorption and metabolism of Vitamin D3 and includes cholestyramine, cholestipol, phenytoin, phenobarbital, orlistat and mineral oil. Also, corticosteroids, such as prednisolone increase the need for Vitamin D3. Cholecalciferol is known to interact with Carbamazepine, Dactinomycin, Diuretics, Fosphenytoin, Micanazole, Phenobarbital, Phenytoin, Primidone.

Contraindications

Vitamin D3 is contraindicated in all diseases associated with hypercalcaemia. It is also contraindicated in patients with known hypersensitivity to Vitamin D3 or any of the components of the products. It is also contraindicated in Severe Renal Impairment, Hypervitaminosis D and Nephrolithiasis.

Side Effects

Occasional acute symptoms including anorexia, lassitude, nausea, vomiting, diarrhea, constipation, weight loss, polyuria, sweating, headache, thirst, vertigo, and raised concentrations of calcium and phosphate in plasma and urine.

Pregnancy & Lactation

Pregnancy: Vitamin D3 demand increases during pregnancy. Vitamin D3 deficiency during pregnancy can affect bone development and immune function from birth through adulthood. Low Vitamin D3 levels are common among those taking a standard prenatal multivitamin, which usually contains 400 lU, but  inadequate for pregnant women. Even 800 IU of vitamin D3, per day didn't permit most pregnant women to reach a normal vitamin D3 level. A recently completed study funded by the national institutes of Health tested the safety and effectiveness of 4000 IU vitamin D3 per day in pregnant women. The researchers reported that this dose was safe and effective in achieving normal vitamin D3 levels and resulted in fewer pregnancy complications (infections, preterm labor, birth, and pre-eclampsia) when compared with 400 lU Vitamin D3 per day.
Lactation: It should be assumed that exogenous vitamin D3 passes into the breast milk. In view of the potential for hypercalcaemia in the mother and for adverse reactions from vitamin D3 in nursing infants, mothers may breastfeed while taking vitamin D3, provided that the serum calcium levels of the mother and infant are monitored. The American Academy of Pediatrics (AAP) currently recommends that breastfeed infants receiving a supplement of vitamin D3 every day prevent Vitamin D3 deficiency and rickets.

Precautions & Warnings

Plasma-calcium concentration should be monitored at intervals in patients receiving high doses of Vitamin D3 in renal impairment, 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.

Storage Conditions

· Store in dry place & protected from light.
· Keep storage within 250 C. temperature.

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