Platinum Pharma




Full Prescribing Info
Dry vitamin D3 and ossein mineral complex.
Each film-coated tablet contains: Dry vitamin D3 400 I.U., composition of the Ossein Mineral Complex 830 mg, Calcium 177.6 mg, Phosphorus 82.2 mg, Residual Mineral Salts 24.9 mg, Collagen 224.0 mg, Other Proteins 66.4 mg.
Pharmacology: Pharmacodynamics: Ossobon-D contains the vitamin D and the ossein mineral components of bone tissue in the physiological proportions, including calcium and phosphate, trace elements, fluoride and other ions, proteins, and glycosaminoglycans. It is given orally to patients requiring both calcium and phosphorus supplementation.
The anti-osteoporotic activity of Ossobon-D is based on a dual effect: An anabolic effect on osteoblast and an anticatabolic effect on osteoclasts. These 2 different types of action are physiologically complementary: Balance bone resorption and bone formation or bone remodeling.
Pharmacokinetics: Vitamin D substance are well absorbed from the gastrointestinal tract, absorption may be decreased in patients with decreased fat absorption.
Vitamin D compounds are hydroxylated first in the liver and further in the kidney, hydroxylation of cholecalciferol form the active metabolites. Vitamin D compounds and their metabolites are excreted mainly in the bile and faeces with only small amount appearing in urine. Certain vitamin D substances may be distributed into breast milk. Vitamin D may accumulate in fat tissue and muscle for a long time. Cholecalciferol has a slow-acting effect but a long duration of action.
Supplemental mineral deficiency, especially calcium and phosphorus.
Dosage/Direction for Use
Take 1 to 2 tablets daily before meals.
Symptoms: anorexia, lassitude, nausea and vomiting, diarrhea, polyuria, sweating, headache, thrist and vertigo.
Treatment: Both the drug and calcium supplements should be withdrawn, maintenance of a low-calcium diet, administration of oral or IV fluids and if needed, corticosteroids or other drugs, particularly calciuric diuretics (e.g. furosemide and ethacrynic acid) to decrease serum calcium concentrations. Hemodialysis or peritoneal dialysis against a calcium-free dialysate may also be used. If ingestion is recent, gastric lavage or emesis may prevent further absorption. If the drug has passed through the stomach, administration of mineral oil may promote fecal elimination.
OSSOBON-D is contraindicated in patients with: History of hypersensitivity to drug; Hypercalcemia and hypercalciuria; Severe renal failure; Urolithiasis.
Higher doses should be reduced in hypercalcemia, hypercalciuria.
Special Precautions
Used carefully in patient with cardiac disease and atherosclerosis.
Use In Pregnancy & Lactation
A characteristic physiognomy, possibly with aortic valvular stenosis, retinopathy, and mental and/or physical retardation, has occurred following prolonged hypercalcemia in infants and in neonates of mothers with hypercalcemia during pregnancy.
Hypercalcemia during pregnancy may also lead to suppression of parathyroid hormone concentrations in the neonate resulting in hypocalcemia, tetany, and seizures. There are no adequate or well controlled studies in pregnant women.
However, the mother and fetus from untreated maternal hypoparathyroidism and hypophosphatemia are considered greater than the risks due to vitamin D therapy.
Vitamin D is distributed into breast milk. Use of vitamin D is usually considered compatible with breast feeding. But large dose should not be administered to the nursing women. The infant should be closely monitored for hypercalcemia or clinical manifestations of vitamin D toxicity if the mother is receiving pharmacological doses of vitamin D.
Adverse Reactions
Doses of vitamin D analogs that do not exceed the physiologic requirement are usually nontoxic.
Chronic administration of excessive doses of vitamin D analogs may lead to hypervitaminosis D and hypercalcemia.
Drug Interactions
Concurrent administration of Phenobarbital, phenytoin may increase cholecalciferol metabolism.
Concurrent administration of thiazides may risk of hypercalcemia.
Concurrent administration of cholestyramine or colestipol hydrochloride may result in decreased intestinal absorption of vitamin D analogs.
Concurrent administration of orlistat may result in decreased GI absorption of fat-soluble vitamins such as vitamin D analogs. At least 2 hours should elapse between (before or after) any orlistat dose and vit D analog administration.
Concurrent use of vitamin D analogs and cardiac glycosides may result in cardiac arrhythmias.
Store below 30°C in a dry place, protect from light.
ATC Classification
A11JB - Vitamins with minerals ; Used as dietary supplements.
FC tab (orange oblong biconvex, plain on one side and break line on reverse) 3 x 10's.
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