Each soft capsule TRIOCOL® 0.25 contain Calcitriol 0.25 mcg
Each soft capsule TRIOCOL® 0.50 contain Calcitriol 0.50 mcg
Calcitriol is an important active metabolite vitamin D3. Calcitriol is normally formed in kidney from its precursor 25-hydroxycholecalciferol (25-HCC). The normal formation is physiologically per day from 0.5 to 1.0 μg, in some cases it may be higher during periods of increased bone synthesis (eg on growth or pregnancy). Calcitriol increases calcium absorption in the intestines and regulates minerals in bone. The pharmacological effects of single-dose Calcitriol treatment last about 3 to 5 days.
The primary role of Calcitriol in the regulation of calcium homeostasis, which includes stimulatory effects on osteoblast activity in bone, provides a pharmacological basis for the effects of osteoporosis therapy.
In patients with renal osteodystrophy, endogenous Calcitriol synthesis is limited or may even cease altogether. This deficiency has an important role in the formation of renal osteodystrophy.
In patients with renal osteodystrophy, administration orally Calcitriol normalizes calcium absorption in the gut. Hypocalcemia increases serum alkaline phosphatase and serum concentrations of parathyroid hormone. It relieves muscle bone pain and corrects histological changes present in fibrous osteitis and other mineralized abnormalities.
In patients with postoperative hypoparathyroid, idiopathic hypoparathyroid and pseudohypoparathyroid, hypocalcemia, and clinical symptoms are corrected with treatment with Calcitriol.
Patients with rickets due to vitamin D deficiency, serum Calcitriol levels are low or absent. If calcium endogenous Calcitriol production in the kidneys is poor, Calcitriol may be considered as a replacement therapy. Patients with vitamin D-resistant rickets and hypophosphatemia in which Calcitriol plasma concentrations decrease, treatment with Calcitriol decreases tubular phosphate elimination and along with phosphate recovery, bone formation is normalized.
Patients with other forms of rickets, such as those associated with neonatal hepatitis, biliary atresia sistonis and calcium diet and vitamin D deficiency, also benefit from therapy with Calcitriol.
– Postmenopausal osteoporosis.
– Renal osteodystrophy in patients with chronic kidney failure, especially in the treatment
– Postoperative hypoparathyroid
– Idiopathic hypoparathyroid
– Rachitis dependent vitamin D
– Rachitis resistant vitamin D hypophosphatemia
Daily optimal dose of Calcitriol should be carefully determined for each patient based on serum calcium values. Treatment with Calcitriol should always start with the lowest possible dose and should not be raised without careful monitoring of serum calcium.
When the optimal dose of Calcitriol has been determined, serum calcium levels should be measured monthly (or as detailed for each indication). An example for a serum calcium estimate is taken by not using a turkit. If serum calcium levels rise to 1 mg / 100 ml (250 μmol) above normal (9 – 11 mg / 100 ml, or 2250 – 2750 μmol / l), or serum creatinine up to> 120 μmol / l, Calcitriol dose should is downgraded or the treatment is stopped completely until the normal calcium returns. During the period of hypercalcemia, serum calcium and phosphate levels should be determined daily. When normal levels have been achieved, treatment with Calcitriol may be continued with a daily dose of 0.25 μg lower than the doses previously used.
Estimated acceptance of calcium through daily food should be made and acceptance adjusted when necessary. The requirement for the optimal effect of Calcitriol is an adequate but not excessive amount of calcium intake (in adults: about 800 mg per day) at the onset of treatment. Calcium supplements may be needed.
Due to the improved absorption of calcium from the gastrointestinal tract, some patients given Calcitriol can be maintained with a lower calcium diet. In patients who are prone to hypercalcaemia, it may only require low-dose calcium or no additives at all.
Total daily calcium intake (among other things from food and if necessary from the drug) should be between 800 mg and no more than 1000 mg.
Special Dose Instruction (Adult)
The recommended dose of Calcitriol is 0.25 μg twice daily.
Serum calcium and creatinine values should be checked after 4 weeks, 3 and 6 months and thereafter at every 6 months.
Renal osteodystrophy (dialysis patients)
The initial dose is 0.25 μg daily. In patients with normal or slightly decreased serum levels, dose 0.25 μg every 2 days is adequate. If there is no satisfactory response to the biochemical parameters and clinical manifestations of the observed disease 2 to 4 weeks, the dose can be raised by 0.25 μg / day at 2 to 4 weeks intervals. During this period, serum calcium levels should be checked at least 2 times a week. Most patients respond to doses between 0.5 and 1.0 μg daily.
Hypoparathyroid and rachitis
Initial dose Calcitriol is 0.25 μg / day given in the morning. If there is no satisfactory response to the biochemical parameters and clinical manifestations of the disease, the dose may be raised at intervals of 2 to 4 weeks. During this period, serum calcium levels should be determined at least 2 times a week. Impaired absorption occasionally occurs in patients with hypoparathyroidism; therefore, a larger dose of Calcitriol may be required.
Dose in the elderly patient
No special dose modifications are required for the elderly patient. It is recommended to monitor serum calcium and creatinine.
Doses in infants and children
Patients aged 1 – 5 years with hypoparatiroidisme usually given a dose of 0.25 to 0.75 μg daily.
Presentation and Registration Number :
TRIOCOL® 0.25 Soft Capsule Box, botlle @ 30 soft capsule; DKL1308019902A1
TRIOCOL® 0.50 Soft Capsule Box, bottle @ 30 soft capsule; DKL1308019902B1
ON MEDICAL PRESCRIPTION ONLY
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