BONE CARE 1 GM 30 TAB; vitamin d2, alfa calcidol, metabolic bone disease agents|therapeutic nutrients, minerals, electrolytes .
ACTIVE-INGREDIENT OF BONE CARE 1 GM 30 TAB
ALFACALCIDOL ( 1-α hydroxycholecalciferol ) 1 mg .
INDICATION OF BONE CARE 1 GM 30 TAB
bone care is indicated in all condditions where there is a disturbance of calcium metabolism due to impaired 1-α hydroxylation such as when there is reduced renal function . The main indications are : – renal osteodystrophy . – hyperparathyroidism ( with bone disease ) . -hypoparathyroidism . – neonatal hypocalcaemia . – nutritional and malabsorptive rickets and osteomalacia . – pseudo – deficiency (D-dependent) rickets and osteomalacia . – hypophosphataemic vitamin D resistant rickets and osteomalacia .
DOSAGE OF BONE CARE 1 GM 30 TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
route of administration : oral . Initial dose for all indications : adults : 1 microgram/day . Dosage in the elderly : 0.5 microgram /day . Neonates and premature infants : 0.05 -0.1 microgram/kg/day . Children under 20 kg body weight : 0.05 microgram/kg/day . Children over 20 kg body weight : 1 microgram/day . method of addministration : the dose of bone care should be adjusted thereafter to avoid hypercalcaemia according to the biochemical response . indices of response include plasma levels of calcium ( ideally corrected for protein binding ) , alkaline phosphatase , parathyroidd hormone , as well as radiographic and histological investigations . plasma levels should initially be measured at weekly intervals . the daily dose of bone care may be increased by increments of 0.;25 – 0.5 microgram . when the dose is stabilized , measurements may be taken every 2-4 weeks . most adult patients respond to doses between 1 and 3 micrograms per day . when there is biochemical or radiographic evidence of bone healing , ( and in hypoparathyroid patients when normal plasma calcium levels have been attained ) , the dose generally decreases . maintenance doses are generally in the range of 0.25 to 1 microgram per day . if hypercalcaemia occurs , bone care should be stopped until plasma calcium returns to normal ( approximately 1 week ) then restarted at half the previous dose . – renal bone disease : patients with relatively high initial plasma calcium levels may have autonomous hyperparathyroidisim , often unresponsive to bone care . other therapeutic measures may be indicated . before and during treatment with bone care , phosphate bindding agents shouldd be considered to prevent hyperphosphataemia . it is particularly important to make frequent plasma calcium measurements in patients with chronic renal failure because prolonged hypercalaemia may aggravate the decline of renal function . – hyperparathyyroidism : in patients with primary or tertiary hyperparathyyroidism about to undergo parathyroidectomy , pre-operative treatment with bone care for 2-3 weeks alleviates bone pain and myopathy without aggravating pre-operative hypercalcaemia . in order to decrease post – operative hypocalcaemia , boner care should be continued until plasma alkaline phosphatase levels fall to normal or hypercalcaemia occurs . – hypoparathyroidism : in contrast to the response to parent vitamin D , low plasma calcium levels are restored to normal relatively quickly with bone care . severe hypocalcaemia is corrected more rapidly with higher doses of bone care ( e.g 3-5 micrograms ) together with calcium supplements . – neonatal hypocalcaemia : although the normal starting dose of bone care is 0.05 – 0.1 microgram /kg/day ( followed by careful titration ) severe cases doses of up to 2 microgram/day/kg may be required . whilst ionised serum calcium levels may provide a guide to response , measurement of plasma alkaline phosphatase activity may be more useful . levels of alkaline phosphatase approximately 7.5 times above the adult range inddicate active disease . a dose of 0.1 microgram/kg/day of bone care has proven effective as prophylaxis against early neonatal hypocalcaemia in premature infants . – nutritional and malabsorptive rickets and osteomalcia : nutritional rickets and osteomalacia can be cured rapidly with malabsorptive osteomalacia ( respondding to large doses of im or iv parent vitamin D ) will respond to small ddoses of bone care . – pseudo-deficiency (D-dependent) rickets and osteomalacia : although large doses of parent vitamin D would be required , effective doses of bone care are similar to those required to heal nutritional vitamin D deficiency rickets and osteomalacia . – hypophosphataemic vitamin D-resistant rickets and osteomalacia : neither large doses of parent vitamin D nor phosphate supplements are entirely sasfactory . treatment with bone care at normal ddosage rapidly relieves myopathy when present and increases calcium and phosphate retention . phosphate supplements may also be required in some patients .
OVER-DOSAGE OF BONE CARE 1 GM 30 TAB
hypercalcaemia is treated by suspending the administration of bone care . In severe cases of hypercalcaemia general supportive measures should be undertaken . Keep the patient well hydrated by i.v. infusion of saline ( force diuresis ) , measure electrolytes , calcium and renal function indices ; assess electrocardiographic abnormalities , espcially in patients on digitalis . more specifically , treatment with glucocorticosteroids , loop diuretics, bisphosphonates , calcitonin and eventually hemodialysis with low calcium content should be considered .
CONTRA-INDICATION OF BONE CARE 1 GM 30 TAB
hypersensitivity , metastatic calcification . Hypersensitivity to alfacalcidol or any of the other ingredients .
STORAGE OF BONE CARE 1 GM 30 TAB
store at temperature not exceeding 30 ° C .
PACK OF BONE CARE 1 GM 30 TAB
carton box containing 1,2,3 (AL/AL) strips ,each of 10 capsules and an inner leaflet .
BONE CARE 1 GM 30 TAB MANUFACTURED BY
the arab company for gelatin and pharmaceutical products for multicare egypt for pharmaceutical industries .