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Rocaltrol

Rocaltrol
This is a form of vitamin D, a fat-soluble vitamin stored in the body. Vitamin D is necessary for normal bone development. This medication is used as a dietary supplement to help prevent and treat rickets (a vitamin D deficiency).

Brand: Calcitriol

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: June 2024
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Rocaltrol 0.25 mg
180 caps - 0.25 mg
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$281.93 $1.57 $101.77 Add to cart
120 caps - 0.25 mg
+ 4 free Viagra 100 mg, 3% discount for future orders
$191.95 $1.60 $63.85 Add to cart
90 caps - 0.25 mg
+ 4 free Viagra 100 mg, 3% discount for future orders
$147.01 $1.63 $44.84 Add to cart
60 caps - 0.25 mg
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$105.95 $1.77 $21.95 Add to cart
30 caps - 0.25 mg $63.95 $2.13 No Add to cart

Product description

Drug Name

Rocaltrol (Calcitriol)

Pharmacological action

Calcitriol is one of the most important active metabolites of vitamin D3. Calcitriol promotes calcium absorption in the intestine and regulates bone mineralization. The pharmacological effect of a single dose of calcitriol lasts 3-5 days.


The key role of calcitriol in the regulation of calcium metabolism, consisting in stimulating the activity of skeletal osteoblasts, is a solid pharmacological basis for its therapeutic action in osteoporosis.


In people with severe renal insufficiency the synthesis of endogenous calcitriol is reduced or may even stop altogether. Calcitriol deficiency plays a major role in the occurrence of renal osteodystrophy.


In patients with renal osteodystrophy, Rocaltrol (synthetic calcitriol) normalizes reduced intestinal calcium absorption, eliminates hypocalcemia, elevated serum levels of alkaline phosphatase and parathormone. It reduces bone and muscle pain, and eliminates the histological changes that occur in fibrous osteitis and other mineralization disorders.


In patients with postoperative and idiopathic hypoparathyroidism and pseudohypoparathyroidism Rocaltrol reduces hypocalcemia and its clinical manifestations.


In patients with vitamin-D-dependent rickets, serum calcitriol concentration is low or completely absent. Given the insufficient endogenous synthesis of calcitriol in the kidneys, taking Rocaltrol can be considered in these patients as replacement therapy.


In patients with vitamin-D-resistant rickets and hypophosphatemia with low plasma calcitriol levels, treatment with Rocaltrol reduces tubular excretion of phosphate and in combination with phosphorus medication normalizes bone development.


Treatment with Rocaltrol also helps with other forms of rickets, such as those caused by neonatal hepatitis, biliary atresia, cystinosis, and alimentary calcium and vitamin D deficiencies.


Pharmacokinetics

Absorption


Calcitriol is rapidly absorbed in the intestine. After a single oral administration of 0.25-1.0 mcg of Rocaltrol, Cmax in serum is reached after 3-6 hours. With repeated administration equilibrium concentrations are reached within 7 days and depend on the dose amount.


Distribution


After a single oral administration of 0.5 µg of Rocaltrol, the mean serum calcitriol concentration rose from an initial value of 40.0±4.4 pkg/ml to 60.0±4.4 pkg/ml after 2 h and then decreased to 53.0±6.9 after 4 h, to 50.0±7.0 after 8 h, to 44±4.6 after 12 h and 41.5±5.1 pkg/ml after 24 h.


In the blood, calcitriol and other vitamin D metabolites bind to specific plasma proteins.


Exogenous calcitriol can be assumed to pass through the placental barrier and into breast milk.


Metabolism


Several calcitriol metabolites have been identified, each with different vitamin D properties: 1a,25-dihydroxy-24-oxo-calciferol, 1a,23,25-trihydroxy-24-oxo-calciferol, 1a,24R,25-trihydroxycalciferol, 1a,25R-dihydroxycalciferol-26,23S-lactone, 1a,25S, 26-trihydroxycolecalciferol, 1a,25-dihydroxy-23-oxolecalciferol, 1a,25R,26-trihydroxy-23-oxolecalciferol, and 1a-hydroxy-23-carboxy-24,25,26,27-tetranorocalciferol.


Excretion


T1/2 of calcitriol from serum is 9-10 hours. However, the pharmacological action of a single dose of calcitriol lasts at least 7 days. Calcitriol is excreted with bile and undergoes intestinal-hepatic recirculation. After intravenous administration of labeled calcitriol healthy volunteers within 24 hours, about 27% of radioactivity is detected in feces and about 7% - in the urine. After oral administration of 1 µg of labeled calcitriol to healthy volunteers, about 10% of total radioactivity is detected in the urine within 24 hours. On day 6 after intravenous administration of labeled calcitriol in the urine is detected 16%, and in the feces - 49% of total radioactivity.


Pharmacokinetics in special cases


In patients with nephrotic syndrome or in patients on hemodialysis, calcitriol levels in serum are decreased, and achievement of Cmax is somewhat delayed.

Contraindications to use

  • All diseases accompanied by hypercalcemia;
  • Hypersensitivity to the drug (or to medicinal products of the same class) or to any other component of the drug;
  • hypervitaminosis D;
  • Children under 3 years of age.

Caution: atherosclerosis, pulmonary tuberculosis, heart failure, phosphate nephrolithiasis, sarcoidosis and other granulomatosis, advanced age (may contribute to atherosclerosis).


Administration during pregnancy and lactation

When oral administration of sublethal doses of vitamin D to pregnant rabbits, fetuses developed supraclavicular aortic stenosis. There is no data on teratogenicity of vitamin D, even at very high doses, in humans. Rocaltrol should be administered to pregnant women only for absolute indications, if the expected effect on the mother exceeds the possible risk to the fetus.


Apparently, exogenous calcitriol penetrates into breast milk. Taking into account possible hypercalcemia in mother and adverse reactions in breast children it is not recommended to use the preparation during breast feeding.


Administration in patients with kidney dysfunction

Chronic hypercalcemia can lead to increase of serum creatinine in patients with normal kidney function.

Administration in children

Contraindication: children under 3 years of age. Special caution must be exercised when prescribing in children younger than 18 years of age.

Administration in elderly patients

Caution: advanced age (may contribute to the development of atherosclerosis).

Indications of the drug Rocaltrol

  • Confirmed postmenopausal osteoporosis;
  • Renal osteodystrophy in patients with chronic renal failure, especially in patients on hemodialysis
  • Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis);
  • postoperative hypoparathyroidism;
  • Idiopathic hypoparathyroidism;
  • pseudohypoparathyroidism;
  • vitamin-D-dependent rickets;
  • Hypophosphatemic vitamin-D-resistant rickets (phosphate-diabetes mellitus).


Dosing regimen 

Standard dosing regimen


Orally. The initial daily dose is 0.25 mcg. The optimal daily dose of Rocaltrol should be carefully chosen for each patient depending on the calcium content in serum. Treatment with Rocaltrol should always be started with the lowest dose possible and increased only with careful monitoring of serum calcium levels.


A prerequisite for optimal effectiveness of Rocaltrol therapy is an adequate, but not excessive intake of calcium with food from the beginning of treatment (about 800 mg/day for adults). In some cases the patient may need to take calcium medication. Due to improved absorption of calcium in the gastrointestinal tract, a reduced calcium intake may be sufficient in some patients receiving Rocaltrol. Patients with a tendency to hypercalcemia should prescribe the drugs only in low doses or discontinue them altogether.


Total daily calcium intake (with food and, if available, with drugs) should average approximately 800 mg and should not exceed 1000 mg.


During the stabilization phase of Rocaltrolom therapy, serum calcium concentrations should be determined at least twice weekly. Once the optimal dose of Rocaltrolam has been selected, serum calcium levels should be checked monthly (or as recommended for individual indications, see below). Blood for calcium determination should be drawn without the use of a tourniquet.


As soon as serum calcium levels are 1 mg/100 ml (250 μmol/L) higher than normal (9-11 mg/100 ml or 2250-2750 μmol/L) or serum creatinine exceeds 120 μmol/L, RocalTrol should be stopped immediately until blood calcium levels normalize.


In hypercalcemia, serum calcium and phosphate levels should be determined daily. Once they are normalized, treatment with Rocaltrol can be continued, reducing the previous dose by 0.25 mcg. Daily dietary calcium intake should be assessed and, if necessary, dietary adjustments should be made.


Dosage in special cases in adults


Postmenopausal osteoporosis: 0.25 mcg 2 times per day. Calcium and creatinine content should be determined after 4 weeks, 3 and 6 months after the treatment start and then every 6 months.


Renal osteodystrophy (patients on dialysis): initial daily dose is 0.25 mcg. For patients with normal or only slightly decreased serum calcium levels, a dose of 0.25 mcg every other day is enough. If biochemical parameters and clinical picture do not improve, the daily dose should be increased by 0.25 mcg at intervals of 2-4 weeks. Serum calcium should be determined at least twice a week during this period. In most patients, the therapeutic effect occurs at a daily dose of 0.5-1.0 mcg.


In patients refractory to continuous therapy, pulse (intermittent) therapy with Rocaltrol at an initial dose of 0.1 mcg/kg 2-3 times per week at bedtime is effective. The maximum total dose of Rocaltrol should not exceed 12 mcg per week.


Secondary hyperparathyroidism (pre-dialysis): in patients with moderate to severe renal insufficiency (CKR 15-55 ml/min) the initial daily dose is 0.25 mcg/day for adults and children over 3 years (corrected for surface area 1.73 m2 ). The daily dose may be increased to 0.5 mcg.


Hypoparathyroidism and rickets: the initial dose is 0.25 mcg/day in the morning. If there is no improvement of biochemical parameters and clinical picture, the dose can be increased at intervals of 2-4 weeks. During this period serum calcium should be determined at least twice a week. In case of hypercalcemia, the administration of Rocaltrol should be stopped immediately until the blood calcium level normalizes. Calcium intake with food should be reduced.


Patients with hypoparathyroidism may sometimes have impaired absorption, including calcium, which may require increasing the dose of Rocaltrol.


If Rocaltrol is prescribed to a pregnant woman with hypoparathyroidism, the drug dose may need to be increased in the second half of pregnancy and decreased after delivery and during lactation.


Patients of advanced age do not require dose adjustment. General recommendations for monitoring serum calcium and creatinine levels should be followed.