ROCALTROL ® is a Calcitriol based drug
THERAPEUTIC GROUP: Vitamin D
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications ROCALTROL ® - Calcitriol
ROCALTROL ® is a calcitriol-based drug used in the treatment of renal osteodystrophy, hypoparathyroidism and vitamin D deficiency rickets.
Recent studies have shown the effectiveness of this drug in the treatment of post-menopausal osteoporosis.
Mechanism of action ROCALTROL ® - Calcitriol
ROCALTROL ® is a calcitriol-based drug, a biologically active form of vitamin D3 also known as 1, 25 dihydroxycholecalciferol.
Taken orally this vitamin is absorbed at the intestinal level, reaching the maximum plasma concentrations within 3-6 hours from the intake, and carrying out the maximum biological efficacy without the intervention of hepatic and renal metabolism.
The presence of the hydroxyl groups in positions 1 and 25, allows the calcitriol present in ROCALTROL ® to skip hepatic and renal hydroxylation, reaching directly the target organs where interacting through specific nuclear receptors guarantees an increase in renal calcium and phosphorus reabsorption, a increased intestinal calcium absorption and finally the modulation of bone mobilization processes.
Numerous experts are still at work to best characterize the biological activity of this vitamin which appears to be involved both in the pathways of pain control and in the regulation of cell proliferation.
Studies carried out and clinical efficacy
1. CALCITRIOLO AND CHRONIC RENAL FAILURE
Work that reaffirms the importance of correct integration with calcitriol, in patients with chronic kidney disease, in which the metabolic capacity of the kidney is seriously compromised.
2. CALCITRIOLO AND CHRONIC INFLAMMATORY DISEASES
Further study that shows how vitamin D can be important in the modulation of the various metabolic pathways and in particular for that which leads to the expression of inflammatory cytokines. This role could therefore be important in the treatment of chronic inflammatory diseases.
3. VITAMIN D3 IN PATIENTS SUBJECT TO HEMODIALYSIS
Supplementation with active vitamin D 3 in patients undergoing hemodialysis has been shown to be effective in improving the control of mineral metabolism, haematopoiesis and in reducing inflammation.
Method of use and dosage
ROCALTROL ®
Capsules of 0.25 - 0.5 mcg of calcitriol:
the therapeutic scheme must be defined by the doctor based on the patient's clinical conditions and the related therapeutic goals.
The initial dosage could be reviewed during treatment in order to optimize the therapeutic effects while minimizing the appearance of side effects.
Warnings ROCALTROL ® - Calcitriol
ROCALTROL ®
Capsules of 0.25 - 0.5 mcg of calcitriol:
the therapeutic scheme must be defined by the doctor based on the patient's clinical conditions and the related therapeutic goals.
The initial dosage could be reviewed during treatment in order to optimize the therapeutic effects while minimizing the appearance of side effects.
PREGNANCY AND BREASTFEEDING
The use of calcitriol in pregnancy is subjected exclusively to continuous medical supervision and the actual need for treatment.
On the contrary, given the high probability that vitamin D3 passes through the breast filter, the use of ROCALTROL ® is contraindicated during breastfeeding.
Interactions
An adjustment of the ROCALTROL ® dosage could be expected following the simultaneous administration of antiepileptics and anticonvulsants such as barbiturates, while the simultaneous intake of active ingredients capable of modulating the calcium-phosphorus metabolism could contribute to the appearance of side effects such as hypercalcemia .
For this reason, in order to avoid the appearance of heart rhythm disorders, patients undergoing digital therapy should be scrupulously supervised by medical personnel.
Contraindications ROCALTROL ® - Calcitriol
ROCALTROL ® contraindicated in case of hypercalcaemia or hypersensitivity to the active substance or to one of its excipients.
Undesirable effects - Side effects
Different studies and careful post-marketing monitoring show that the administration of calcitriol is well tolerated and has no clinically relevant side effects, if maintained within conventional therapeutic schemes.
In fact, excessive dosages or long-term administrations could be responsible for the appearance of nausea, diarrhea, anorexia, weight loss, polyuria, sweating, headache, thirst, dizziness, hypercalcemia, hypercalciuria and hyperfostatemia with the relative complications.
Fortunately the aforementioned side effects tend to regress quite readily once the therapy is suspended or the dosage adjusted.
Note
ROCALTROL ® can only be sold under strict medical prescription
