Expiration date: 03/2025
The composition and form of issue:
Capsules. 1 capsule contains:
calcitriol 0,25 or 0.5 mg
excipients: butylhydroxytoluene butylhydroxyanisole the medium-chain triglycerides
capsule shell: gelatin glycerol (glycerin) 85% Karion 83 (containing 2 to 4% mannitol, 27-35% sorbitol, 61-71% of hydrogenated starch hydrolyzed) titanium dioxide (E171), the colorant iron oxide red (E172), the colorant iron oxide yellow (E172)
blistere in 10 PCs. in cardboard pack 3 blisters.
Method of application and dose:
Inside.
The standard dosing regimen
The initial daily dose is 0.25 ág. The optimal daily dose of Rocaltrol must be carefully selected for each patient depending on the calcium content in the serum. Treatment Rocaltrol you should always start with a smaller dose and increase it only with careful monitoring of calcium level in serum.
A necessary condition for the optimal effectiveness of therapy Rocaltrol is sufficient, but not excessive intake of calcium from food into the treatment (for adults is about 800 mg/day). In some cases the patient may require supplementation. By improving calcium absorption in the gastrointestinal tract, some patients receiving Rocaltrol may be adequate and a low supply of calcium. Patients with a tendency towards hypercalcemia should prescribe drugs only in small doses, or even to cancel them.
Total daily calcium intake (from food and/or drugs) should be on average approximately 800 mg and should not exceed 1000 mg.
In the stabilization phase of therapy Rocaltrol the concentration of serum calcium should be determined at least 2 times a week. After the selection of the optimal dose of Rocaltrol serum calcium levels should be checked monthly (or as recommended on individual indications). Blood sampling to determine the level of calcium should be carried out without the use of harness.
Once the levels of serum calcium by 1 mg/100 ml (250 µmol/l) above normal (9-11 mg/100 ml, or 2250-2750 µmol/l) or the creatinine of serum exceeds 120 mmol/l, receiving Rocaltrol should cease immediately until the normalization of the calcium level in the blood.
If hypercalcemia levels of calcium and phosphate in the serum should be determine on a daily basis. After normalization treatment Rocaltrol you can continue by decreasing the previous dose by 0.25 mcg. Should be assessed daily intake of dietary calcium and, if necessary, to make adjustments in the diet.
Dosing in special cases in adults
Postmenopausal osteoporosis: 0,25 mcg 2 times per day. The content of calcium and creatinine should be determined after 4 weeks, 3 and 6 months after starting treatment and then every 6 months.
Renal osteodystrophy (dialysis patients): the initial daily dose is 0.25 ág. Patients with normal or only slightly reduced serum calcium enough doses of 0.25 mcg every other day. If the biochemical parameters and the clinical picture does not improve, the daily dose should be increased by 0.25 mcg at intervals of 2-4 weeks. During this period you should determine the level of serum calcium at least 2 times a week. In most patients the therapeutic effect occurs at a daily dose of 0.5–1 µg.
In patients refractory to continuous therapy, an effective pulse (intermittent) therapy, Rocaltrol initial dose — 0.1 mg/kg 2-3 times a week at night. The maximum total dose of Rocaltrol should not exceed 12 micrograms per week.
Secondary hyperparathyroidism (prevalis): in patients with moderate and severe renal insufficiency (Cl creatinine 15-55 ml/min), the initial daily dose is 0.25 mcg/day for adults and children older than 3 years (adjusted for the surface area of 1.73 m2). The daily dose may be increased to 0.5 µg.
Hypoparathyroidism and rickets: the initial dose of 0,25 mg/day, in the morning. If no improvement of biochemical parameters and the clinical picture is not observed, the dose may be increased at intervals of 2-4 weeks. During this period you should determine the of serum calcium at least 2 times a week. If hypercalcemia receiving Rocaltrol should be immediately discontinued until normalization of calcium level in the blood. You should reduce the intake of foods containing calcium.
Patients with hypoparathyroidism may occur occasionally malabsorption including calcium, which may require increasing the dose of Rocaltrol.
If Rocaltrol administered to a pregnant woman with hypoparathyroidism, in the second half of pregnancy may require increased doses of the drug, and after childbirth and during lactation decrease.
Dosing in elderly patients. Elderly patients dose adjustment is not required. You must adhere to the General recommendations for control levels of calcium and creatinine in serum.
