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= Dvion Soft Gel Capsule = For the use of only a Registered Medical Practitioner or a Hospital or a Laboratory

Prescribing Information Dvion soft gel capsule

Description Dvion contains Cholecalciferol or Vitamin D3, a vitamin D analogue which is used in the treatment of vitamin D deficiency states.

Composition Each soft gel capsule contains:

Cholecalciferol (vitamin D3) IP ......................................................... 1000 IU

Clinical Pharmacology

Vitamin D3 or cholecalciferol is produced in skin and is sequentially metabolized by the liver and kidney to the biologically active form 1,25-dihydroxyvitamin D3 [1,25(OH)2D3]. It is a seco-steroid hormone that regulates calcium homeostasis within the body. The actions of 1,25(OH)2D3 are modulated through the vitamin D receptor (VDR). VDR belongs to a superfamily of nuclear receptors that transduce hormonal signals from the immediate environment and transactivate genes in response to these signals. Vitamin D promotes calcium absorption in the gut and maintains physiological serum calcium and phosphate concentrations that help in normal mineralization of bone and to prevent hypocalcemic tetany. It is also required for bone growth and bone remodeling by osteoblasts and osteoclasts. Vitamin D deficiency can make bones become thin, brittle or misshapen. Vitamin D in sufficient levels prevent rickets (in children) and osteomalacia (in adults), also it helps in protecting older individuals from osteoporosis. It has also been found helpful in preventing falls and fracture incidences among elderly individuals. Serum levels of 25-hydroxy-vit D are measured to define the states of vitamin deficiency as follow: Serum 25(OH)D concentration ˂ 30 ng/mL: Vitamin D deficiency.

By providing vitamin analogues, the serum levels of 25(OH)D concentration are brought to or above the defined normal levels.

Orally supplied cholecalciferol or vitamin D3 is readily absorbed from the small intestine if fat absorption is normal. Bile is required for absorption. Cholecalciferol is activated by the 2-step process. Vitamin D is eliminated renally and by biliary excretion.

Indications Prevention and treatment of vitamin D deficiency states.

Contraindications Known hypersensitivity to vitamin D3, Hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, hypervitaminosis D.

Warnings Keep out of the reach of children.

Precautions Cholecalciferol is usually nontoxic in physiologic doses. Chronic or acute administration of excessive doses may lead to hypervitaminosis D, manifested by hypercalcemia and its sequelae.

Periodic monitoring of serum calcium, phosphate, magnesium, alkaline phosphatase is recommended for patients taking vitamin D analogs. Serum calcium should be maintained in the range of 2.25 to 2.5 mmol/L and not allowed to exceed 2.75 mmol/L. Use in Pregnancy/Lactation/Geriatric patients:

Pregnancy: The use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific case outweigh the significant hazards involved. The safety in excess of 400 USP Units of vitamin D daily during pregnancy has not been established. As the data on use of vitamin D3 in lactating females is limited, its use should be weighed against the risks involved. In geriatric age group, it can be used, with caution, after individualization of dosages.

Adverse Drug Reactions Vitamin D analogs are well tolerated in normal daily doses. Chronic excessive dosing can lead to toxicity. Hypervitaminosis D is characterized by effects on the following organ system:

Renal: Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death. CNS: Mental retardation. Soft Tissues: Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Skeletal: Bone demineralization (osteoporosis) in adults occurs concomitantly. Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism) vague aches, stiffness, and weakness. Gastrointestinal: Nausea, anorexia, constipation. Metabolic: Mild acidosis, anemia, weight loss.

Drug Interactions Mineral Oil, Cholestyramine, Colestipol: Intestinal absorption of vitamin D3 may be impaired when co-administered. Patients on cholestyramine or colestipol should be advised to allow as much time as possible between the ingestion of these drugs and vitamin D3.

Thiazide Diuretics: Concurrent administration of thiazide diuretics and vitamin D3 to hypo- parathyroid patients may cause hypercalcemia which may be transient or may require discontinuation of vitamin D3.

Incompatibilities with other Drugs: Data not available

Overdosage The therapeutic index of vitamin D analogs is narrow, and there is great interindividual variation in the dose that may lead to chronic toxicity. Early symptoms of hypercalcemia may include weakness, fatigue, somnolence, headache, anorexia, dry mouth, metallic taste, nausea, vomiting, vertigo, tinnitus, ataxia, hypotonia. Later and possibly more serious manifestations include nephrocalcinosis, renal dysfunction, osteoporosis in adults, impaired growth in children, anemia, metastatic calcification, pancreatitis, generalized vascular calcification and seizures.

Treatment of acute or chronic intoxication includes withdrawal of the vitamin D3 and any calcium supplements, administration of oral or i.v. fluids and possibly corticosteroids or calciuric diuretics such as furosemide and ethacrynic acid. Peritoneal or hemodialysis with calcium free dialysate will help remove calcium.

If acute ingestion is recent, gastric lavage or emesis may minimize further absorption. If the drug has already passed through the stomach, administration of mineral oil may promote fecal elimination.

Hypercalcemia is usually reversible; however if metastatic calcification has occurred, severe renal or cardiac failure or even death may result.

Dosage and Administration Each soft gel capsule containing 1000 IU to be administered once or twice a day or as directed by the physician.