Universal reference book for medicines
Product name: OSTEOTRIOL ® (OSTEOTRIOL)

Active substance: calcitriol

Type: A drug regulating the exchange of calcium and phosphorus

Manufacturer: Teva Pharmaceutical Industries (Israel) manufactured by RPSCHERER (Germany)
Composition, form of production and packaging
Capsules
soft gelatinous, oval, opaque, yellow, with the inscription "0.25";
the contents of the capsules are a clear, oily solution of light yellow color.
1 caps.

calcitriol 0.25 μg

Auxiliary substances: butylhydroxyanisole (BGA), butylhydroxytoluene (BHT), glyceryl caprylcaprate.

The composition of the capsule shell: gelatin, glycerol 85%, sorbitol 70%, titanium dioxide (E171), dye quinoline yellow (E104).

Ink composition: shellac 54%, ferric oxide black oxide (E172) 46%.

30 pcs.
- vials of polypropylene (1) - packs cardboard.
100 pieces.
- vials of polypropylene (1) - packs cardboard.
Capsules soft gelatinous, oblong, opaque, yellow, with the inscription "0.5";
the contents of the capsules are a clear, oily solution of light yellow color.
1 caps.

calcitriol 0.5 μg

Auxiliary substances: butylhydroxyanisole (BGA), butylhydroxytoluene (BHT), glyceryl caprylcaprate.

The composition of the capsule shell: gelatin, glycerol 85%, sorbitol 70%, titanium dioxide (E171), dye quinoline yellow (E104), dye blue patented (E131) 85%.

Ink composition: shellac 54%, ferric oxide black oxide (E172) 46%.

30 pcs.
- vials of polypropylene (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2005.

PHARMACHOLOGIC EFFECT

Calcitriol - 1.25? (OH) 2D 3 - an active metabolite of vitamin D 3 , which possesses all the properties of natural vitamin D 3 .
By biological activity is much superior to natural vitamin D 3 . Calcitriol increases calcium absorption in the intestine, its reabsorption in the kidneys, promotes the mineralization of bones. In addition, calcitriol is involved in the growth and differentiation of bone cells, as well as in maintaining neuromuscular transmission, the functioning of striated muscle, modulating immune responses. The mechanism of action of calcitriol is associated with interaction with specific receptors localized in the cell nucleus (genomic mechanism), as well as on the plasma membrane of target cells (non-genomic mechanism). The effect of the drug is accompanied by a normalization of decreased calcium absorption in the intestine, its reabsorption in the kidneys and an increase in the concentration in the blood plasma, suppression of the secretion of parathyroid hormone. With its application, pain in the bones and muscles is reduced, and the mineralization of the skeleton improves.
PHARMACOKINETICS

After oral administration, it is rapidly absorbed into the intestine.
C max in the blood serum is reached after 4-6 hours. In the blood it binds to specific plasma proteins.It penetrates the placental barrier and is excreted into breast milk. Biotransformation of the drug occurs with the formation of a number of metabolites, which have a varying degree of activity of vitamin D 3 . T 1/2 is 3-6 hours, however, due to high lipophilicity, the drug and its metabolites can partially accumulate in adipose tissue, so that the pharmacological effect can be kept up to 3-5 days. It is excreted with bile and, in part, is subjected to intestinal-hepatic recirculation. In patients who are on hemodialysis, the concentration in the blood serum is reduced, and its maximum concentration is reached after a longer period of time.
INDICATIONS

- renal osteodystrophy in chronic renal failure (especially in patients on hemodialysis);

- postmenopausal, senile and steroid osteoporosis;

- postoperative hypoparathyroidism, idiopathic hypoparathyroidism and pseudohypoparathyroidism.

DOSING MODE

Capsules are taken orally by washing with water.

Renal osteodystrophy (dialysis patients)

In patients with normal and slightly reduced serum calcium levels, the drug is usually used at a dose of 0.25 μg / day every other day.
In the absence of a satisfactory effect, the dose can be increased by 0.25 μg with an interval of 2-4 weeks. As a rule, a dose of 0.5-1 μg / day provides the necessary clinical effect.
Postmenopausal, senile and steroid osteoporosis

By 0.25 mcg 2 times / day, long.

Hypoparathyroidism

Treatment begins with a dose of 0.25 μg 1 time / day in the morning.
If necessary, the dose can be increased at intervals of 2-4 weeks or 0.25 μg to 0.5-1 μg / day.
SIDE EFFECT

The drug is well tolerated, rarely causes side effects.

In some cases, when taking Osteotriol, hypercalcemia, hypercalciuria, symptoms of which include nausea, vomiting, constipation, abdominal pain, anorexia, lethargy, headache, drowsiness and apathy may occur.

In patients with normal renal function, chronic hypercalcemia can lead to an increase in serum creatinine.

The appearance of these effects indicates an excess of the dose.

The likelihood of hypercalcemia is higher in patients with renal insufficiency, hyperparathyroidism, or on hemodialysis.
In very rare cases (especially in the presence of hypercalcemia and hyperphosphataemia) calcification of soft tissues may develop.
CONTRAINDICATIONS

- diseases accompanied by hypercalcemia and hyperphosphatemia, hypervitaminosis D;

- Hypersensitivity to the drug, as well as to other preparations of vitamin D;

- lactation period;

- childhood.

PREGNANCY AND LACTATION

The use of osteotriol in pregnancy is possible only if the intended benefit to the mother exceeds the possible risk to the fetus.

The drug is contraindicated during lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution, the drug is used for kidney failure.

APPLICATION FOR CHILDREN

The drug is contraindicated in childhood.

APPLICATION IN ELDERLY PATIENTS

In elderly patients, special careful dosage adjustment is required to prevent hypercalcemic complications.

SPECIAL INSTRUCTIONS

With caution, the drug is used for cardiac and renal failure, phosphate nephrolithiasis, sarcoidosis and other granulomatosis.

In elderly patients, special careful dosage adjustment is required to prevent hypercalcemic complications.

During the treatment with osteotriol, do not prescribe other preparations of vitamin D, including its derivatives.
Do not also eat a significant amount of food, enriched with vitamin D (butter, eggs).
During the period of treatment, it is necessary to regularly monitor the level of calcium and inorganic phosphates in blood and urine, especially in patients with renal osteodystrophy, as well as long-term bed rest (in particular, after surgery).

In order to prevent hypercalcemia, the dose of Osteotriol is calculated based on the patient's reaction to the drug and is selected individually.
The effectiveness of treatment is provided by determining an adequate daily dose of calcium, including, if necessary, changes in diet, as well as taking calcium-containing supplements or drugs. Due to improved absorption of calcium in the digestive tract, some patients receiving calcitriol can do with a reduced intake of calcium preparations, and in some cases (with a tendency to hypercalcemia) dispense with their intake.
It is necessary to monitor the serum calcium level at least twice a week during the period of application of the drug.
If the serum calcium level is exceeded by 1 mg / 100 ml (250? Mol / l), compared to the accepted norm - 9-11 mg / 100 ml (2250-2750? Mol / l), or serum creatinine level increase blood up to 120? mol / l and above taking osteotriol should be stopped immediately. Renewal of treatment is allowed only after the normalization of the serum calcium level within the permissible regulatory range using a 0.25 μg dose of the drug.
With the simultaneous administration of barbiturates or anticonvulsants, an increase in the dosage of calcitriol may be required.

In the initial period of treatment of osteoporosis, it is necessary to measure the concentration of calcium in the serum and creatinine after 4 weeks, 3 months and 6 months.
At the end of this period, it is necessary to carry out control analyzes of these indicators at intervals of 6 months.
Patients with normal kidney function who take Osteotriol should avoid dehydration, ensuring that they receive sufficient fluid.

OVERDOSE

Symptoms of acute poisoning: anorexia, headache, vomiting, constipation.

Symptoms of chronic poisoning: dystrophy, weakness, weight loss, sensitivity disorder, fever with thirst, polyuria, dehydration, apathy, urinary tract infections, foci of calcification in internal organs.

Treatment

In case of an accidental overdose: a gastric lavage or the use of an emetic to prevent further absorption of the drug.
With the development of hypercalcemia, therapy with osteotriol should be discontinued, a diet with a low calcium content should be prescribed and the patient should be kept under medical supervision until the calcium concentration in the blood plasma is normalized. After this, therapy can be resumed either with a reduced dose, or the same, but with large intervals of drug intake. In the case of acute hypercalcemia, the patient needs to hydrate to increase diuresis. With increased bone resorption, calcitonin helps reduce calcium in the serum.
DRUG INTERACTION

With the simultaneous use of osteotriol with digitalis preparations, the risk of arrhythmia increases, and with magnesium-containing drugs (eg, antacids), the risk of hypermagnesemia increases, and therefore these drugs should not be given to patients on hemodialysis who receive Osteotriol.

The use of drugs that are inducers of hepatic enzymes (phenytoin, phenobarbital) can cause an increase in the metabolism of the drug and a decrease in the concentration of calcitriol in the blood serum, so that simultaneous use of Osteotriol and these drugs may require higher doses of calcitriol.

Kolestiramin can reduce the intestinal absorption of fat-soluble vitamins, including.
calcitriol.
The use of osteotriol together with thiazide diuretics can increase the risk of hypercalcemia.

When Osteotriol is used because of the risk of hypercalcemia, simultaneous prescription of other preparations of vitamin D and its derivatives is not allowed.

TERMS OF RELEASE FROM PHARMACY

According to the doctor's prescription


TERMS AND CONDITIONS OF STORAGE

List B. At temperatures not higher than 30 ° C in a place inaccessible to children.

Shelf life - 2 years.
Do not use after the expiration date printed on the package.
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