Rocaltrol - instructions for use, reviews, analogs and forms of release (capsules or tablets 0.5 μg, 0.25 μg) drugs for the treatment of rickets, osteoporosis, other disorders of calcium and phosphorus metabolism in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Rockaltrol. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Rocaltrol in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Rockaltrol in the presence of existing structural analogues.Use for the treatment of rickets, osteoporosis, other disorders of calcium and phosphorus metabolism in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Rockaltrol - A drug that normalizes the calcium content in bone tissue, stimulates osteogenesis, regulates the exchange of calcium. Calcitriol (active ingredient of the drug Rocaltrol) is one of the most important active metabolites of vitamin D3. Calcitriol promotes absorption of calcium in the intestine and regulates the mineralization of bones. The pharmacological effect of a single dose of calcitriol lasts 3-5 days. The key role of calcitriol in the regulation of calcium metabolism, which is to stimulate the activity of osteoblasts of the skeleton, is a reliable pharmacological basis for its therapeutic effect in osteoporosis.

Composition

Calcitriol + auxiliary substances.

Pharmacokinetics

Calcitriol is rapidly absorbed into the intestine. After a single oral intake of 0.25-1.0 μg of Rocaltrol, the maximum serum concentration is achieved in 3-6 hours. With repeated administration, equilibrium concentrations are reached within 7 days and depend on the dose value.

In the blood, calcitriol and other metabolites of vitamin D bind to specific plasma proteins. It can be assumed that exogenous calcitriol penetrates the placental barrier and into breast milk.

The half-life of calcitriol from serum is 9-10 hours. However, the pharmacological effect of a single dose of calcitriol lasts not less than 7 days. Calcitriol is excreted with bile and is subjected to intestinal hepatic recirculation.

Indications

• confirmed postmenopausal osteoporosis;
• renal osteodystrophy in patients with chronic renal failure, especially in those on hemodialysis;
• secondary hyperparathyroidism in patients with moderate and severe degree of chronic renal failure (pre-dialysis);
• postoperative hypoparathyroidism;
• idiopathic hypoparathyroidism;
• pseudohypoparathyroidism;
• vitamin-D-dependent rickets;
• hypophosphatemic vitamin-D-resistant rickets (phosphate-diabetes).

Forms of release

Capsules 0.5 μg, 0.25 μg (sometimes mistakenly called tablets).

Instructions for use and dosing regimen

Inside. The initial daily dose is 0.25 μg.The optimal daily dose of Rocaltrol should be carefully selected for each patient, depending on the calcium content in the serum. Treatment with ROCALTROL should always be started with as little dosage as possible and increased only with careful monitoring of serum calcium levels.

A necessary condition for the optimal effectiveness of therapy with Rocaltrol is sufficient, but not excessive, intake of calcium from food from the beginning of treatment (for adults - about 800 mg per day). In some cases, the patient may need to take calcium preparations. By improving absorption of calcium in the gastrointestinal tract, some patients receiving Rocaltrol may also have a low intake of calcium. Patients with a tendency to hypercalcemia should be prescribed drugs only in small doses or in general to abolish them.

The total daily intake of calcium (with food and, if it is, with drugs) should be, on average, about 800 mg and not exceed 1000 mg.

At the stage of stabilizing therapy with Rocaltrol, the serum calcium concentration should be determined at least twice a week.After choosing the optimal dose of Rocaltrol, serum calcium levels should be checked on a monthly basis. Blood to determine calcium should be taken without the use of a tourniquet.

As soon as the serum calcium level is 1 mg 100 ml higher than the norm (9-11 mg per 100 ml) or serum creatinine exceeds 120 μmol per liter, taking Rocaltrol should be stopped immediately before the normalization of the calcium level in the blood.

With hypercalcemia, the levels of calcium and phosphate in the serum should be determined daily. After their normalization, treatment with Rocaltrol can be continued, reducing the previous dose by 0.25 μg. You should estimate the daily intake of calcium from food and, if necessary, make adjustments to the diet.

Side effect

• anorexia (general weakness);
• headache;
• vomiting;
• pain in the upper abdomen;
• constipation;
• dystrophy (impaired nutrition of tissues and organs);
• sensitivity disorders;
• fever;
• thirst;
• polyuria (increased urine formation);
• dehydration;
• apathy;
• growth retardation;
• urinary tract infections;
• hypersensitivity reactions (itching, rashes, urticaria).

Contraindications

• all diseases accompanied by hypercalcemia;
• hypersensitivity to the drug (or to medicines of the same class) or to any other component of the drug;
• hypervitaminosis D;
• children's age up to 3 years.

Carefully:

• atherosclerosis;
• pulmonary tuberculosis;
• heart failure;
• phosphate nephrolithiasis;
• sarcoidosis and other granulomatosis;
• elderly age (may contribute to the development of atherosclerosis).

Application in pregnancy and lactation

Data on the teratogenicity of vitamin D, even very large doses, for a person there. Assign Roccalthrol to pregnant women only on absolute indications if the expected effect for the mother exceeds the possible risk to the fetus.

Apparently, exogenous calcitriol penetrates into breast milk. Given the possible hypercalcemia in the mother and adverse reactions in infants, it is not recommended to take the drug during breastfeeding.

Use in children

Contraindicated in children under the age of 3 years. Special care should be taken when prescribing to children under 18 years of age.

Application in elderly patients

Older patients, Rocaltrol is administered with caution because of the risk of developing atherosclerosis.

special instructions

There is a close relationship between the treatment of calcitriol and the onset of hypercalcemia. Hypercalcemia can develop with an increase in calcium intake in the body when food changes (for example, increased consumption of dairy products) or uncontrolled intake of calcium preparations. Patients and their families should be informed of the need for strict adherence to the prescribed diet; they should also be trained to recognize the symptoms of hypercalcemia.

Particularly high risk for the development of hypercalcemia is experienced by patients who have been in bed for a long time, for example, who underwent surgery.

Calcitriol increases the content of inorganic phosphates in the serum. This effect, being desirable in patients with hypophosphatemia, requires caution in patients with renal insufficiency because of the danger of ectopic calcification. In such cases, the phosphate content in the plasma should be maintained at a normal level (2-5 mg per 100 ml) by oral administration of phosphate binding drugs and a low phosphate diet.

Patients with vitamin-D-resistant rickets (familial hypophosphatemia) receiving Rocaltrol should continue to take oral phosphate.It should, however, be remembered about the stimulation of intestinal absorption of phosphates by the action of Rocaltrol, since this effect may change the need for additional prescription of phosphates. It is necessary to regularly determine the content of calcium, phosphorus, magnesium and alkaline phosphatase in the serum, as well as calcium and phosphate in the daily urine. During the stabilizing (initial) phase of treatment with Rocaltrol, the calcium content in the serum should be monitored at least twice a week.

Since calcitriol is the most pharmacologically active metabolite of vitamin D from all the existing ones, during treatment with Rocaltrol one should not prescribe other vitamin D preparations in order to avoid the development of hypervitaminosis D.

If the patient is transferred from ergocalciferol (vitamin D2) to calcitriol, the normalization of ergocalciferol in the blood may take several months.

Patients with normal kidney function who take Rocaltrol should avoid dehydration, following the sufficient intake of fluid.

Drug Interactions

Because calcitriol is one of the most important active metabolites of vitamin D3,To avoid possible additive effects and hypercalcemia for the duration of treatment with Rocaltrol, medication doses of vitamin D and its derivatives should be discontinued.

Simultaneous treatment with thiazide diuretics increases the risk of hypercalcemia. Patients receiving digitalis preparations, a dose of calcitriol should be selected very carefully, since hypercalcemia in them can provoke arrhythmias.

There is a functional antagonism between vitamin D analogues that enhance calcium absorption, and corticosteroids that suppress it.

Preparations containing magnesium (for example, antacids) can cause hypermagnesemia and therefore should not be given to patients on chronic hemodialysis during treatment with Rocaltrol.

Since Rocaltrol affects phosphate transport in the intestines, kidneys and bones, the dose of phosphate binding drugs should be adjusted depending on serum phosphate levels (normally 2-5 mg per 100 ml).

The use of enzyme inducers such as phenytoin or Phenobarbital can increase metabolism and thereby reduce the concentration of calcitriol in the serum, so the simultaneous use of these drugs may require higher doses of calcitriol.

Kolestyramin can reduce the intestinal absorption of fat-soluble Vitamins and, in particular, calcitriol.

Analogues of Roccalrol

Structural analogs for the active substance:

• Osteotriol.

Analogues on the pharmacological group (correctors of bone and cartilage tissue metabolism):

• Aklast;
• Actonel;
• Alendercourne;
• Alendronate;
• Alflutop;
• Alpha D3 Teva;
• Alfadol;
• Aminoarthrin;
• Heredia;
• Artogistan;
• Artradol;
• Arthrakam;
• Artrafic;
• Biartrin;
• Bivalos;
• Blazter;
• Bonviva;
• Bondronate;
• Bonefos;
• Veprena;
• Veroclast;
• Vivanat;
• Videchol;
• Glucosamine;
• Dihydrotachysterol;
• Don;
• Zemplar;
• Zoledronate;
• Zoledrax;
• Zolerix;
• Zometa;
• Calcitonin;
• Cartilag;
• Klobir;
• Complivit;
• Xidifon;
• Myacalcic®
• Mukosat;
• Oxidevite;
• Ossin;
• Ostalon;
• Osteover;
• Osteogenon;
• Osteolate;
• Osteotriol;
• Osteohin;
• Ostererepair;
• Piascladed;
• Pimegar;
• Prolia;
• Resoclastine;
• Resorb;
• Rizarteva;
• Risendros;
• Rumalon;
• Sinoarth;
• Skelid;
• Stringos;
• Structum;
• Sustilac;
• Tazan;
• Tahistin;
• Tevanath;
• Tridin;
• Fitin;
• Forosa;
• Forste;
• Fosamax;
• Chondraktiv;
• Chondramine;
• Hondrogaard;
• Chondroglucide;
• Chondroitin;
• Chondroxide;
• Chondrolon;
• Honsat;
• Honsurid;
• Exidgiva;
• Elbon;
• Ethalph;
• The Unium.

Review of the endocrinologist

Rocaltrol is an effective medicine that regulates calcium-phosphorus metabolism. Its main active ingredient calcitriol enhances calcium absorption in the gastrointestinal tract, promotes the regulation of the mineralization of bones. I appoint Roctalrol to women with postmenopausal osteoporosis. Effective drug for rickets, renal osteodystrophy, various types of hypoparathyroidism. Treatment with the drug is tolerated well by patients. However, in the process of therapy, in order to prevent hypercalcemia, you should carefully monitor the level of calcium in the blood. At the first manifestations of hypercalcemia should immediately stop taking capsules.

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