Dihydrotachysterol (Dihydrotachysterol)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDihydrotachysterolDihydrotachysterol
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  • Dihydrotachysterol
    drops inwards 
    NPK ECHO, CJSC     Russia
    • Dosage form: & nbspDrops for ingestion in oil.
    Composition:In 1 ml of the drug contains: active substance: dihydrotachysterol - 1 mg; auxiliary substance: glyceryl caprylcaprate (medium chain triglycerides) up to 1 ml.
    Description:
    Transparent oily liquid is colorless or slightly yellow in color, odorless.

    Pharmacotherapeutic group: calcium-phosphorus exchange regulator.
    ATX: & nbsp

    A.11.C.C.02   Dihydrotachysterol

    Pharmacodynamics:

    Synthetic analogue of vitamin D. Increases the concentration of calcium in the blood, both by increasing its absorption in the intestine, and as a result of mobilization of calcium from the bone. In addition, it stimulates the absorption of phosphate from the small intestine, and also increases the excretion of inorganic phosphorus by the kidneys. Regulates the mineralization of bone tissue. The effect of the drug manifests itself faster than that of the vitamin D2 (ergocalciferol) and vitamin D3 (colcalciferol).

    Unlike vitamins D2 and D3, dihydrotachysterol can be used for severe kidney damage, in particular with renal osteodystrophy, since it does not require activation in the kidneys.

    Pharmacokinetics:

    After ingestion, it is absorbed well in the intestine, the maximum concentration in the plasma is reached only 6 hours after admission.Absorption can be impaired in diseases of the liver, bile ducts or gastrointestinal tract. Dihydrotachysterol in the liver it is converted mainly into two active metabolites - 25-hydroxydihydrotachysterol and 1α, 25-dihydroxydihydrotachysterol, which bind to the receptors of 1α, 25-dihydroxyvitamin D - Hormonal form of vitamin D and show an effect similar to it. Unlike vitamins D2 and D3, the formation of active metabolites of dihydrotachysterol is not regulated by the type of feedback. Therefore, the concentration of 25-hydroxydihydrotachysterol in the blood grows linearly with increasing intake of the drug, which necessitates careful selection and control of the dose of the drug that provides a normal level of calcium in the blood and the absence of hypercalcemia. The half-life of dihydrotachysterol is 10.5-13 hours. It is deposited in the liver, fat, skin, muscles and bones. Excretion: mainly through bile with feces. With prolonged use of dihydrotachisterol in therapeutic doses, the concentration of dihydrotachysterol in the plasma is linearly related to the daily dose.

    With prolonged intake of the drug at a dose of 1 mg per day, the concentration of calcium in the blood serum, as a rule, remains constant. Does not cause addictive phenomena.

    Indications:Hypocalcemia on the background of hypoparathyroidism (postoperative, idiopathic, tumor, sarcoidosis or tuberculosis), tetany.
    Contraindications:
    - All diseases accompanied by hypercalcemia; hypersensitivity to the drug (or to drugs of the vitamin D group).

    - Hypervitaminosis D.

    - Hypermagnesia.

    - Organic damage to the heart in the decompensation stage.

    The drug is not recommended for children, because there are no data on the safety of dihydrotachysterol in children. If you have any of these diseases, consult a doctor before taking the drug.
    Pregnancy and lactation:Dihydrotachysterol in small amounts penetrates through the placental barrier and into breast milk. Avoid the use of the drug during pregnancy and lactation.
    Dosing and Administration:

    The drug is used inside after eating. Dosage with drops from a dropper or eye dropper.One drop of the drug contains 0.03 mg of dihydrotachysterol; in 1 ml of the drug an average of 33 drops. The dose is set individually depending on the patient's condition and the content of calcium and phosphorus in the blood. It should be chosen such a dose, in which the calcium content in the blood will be near the lower limit of the norm.

    With hypoparathyroidism - for adults, the initial dose is from 0.8-2.4 mg (27-80 drops) once a day for 4 days, with pronounced shifts in the calcium and phosphorus content in the blood serum pass to a maintenance dose of 0.2 -1.0 mg (7-33 drops) per day. Treatment is carried out for a long time (from 2-3 months to a year or more), depending on the severity of the disease.

    With tetany - 0.5-1.5 mg / day (17-50 drops) for 7-10 days, with improvement - 0.25-0.5 mg / day (8-17 drops) for the next 3 days, maintaining The dose is from 0.25 to 1 mg (8-33 drops) per week.

    Technical information. When dosing the drug with a dropper to increase the accuracy of dosing should keep the bottle upright.

    Side effects:Hypercalciuria against a background of normal or decreased calcium in the blood. Allergic reactions.
    Overdose:

    In case of an overdose, there may be signs of hypercalcemia. Early signs hypercalcemia: loss of appetite, nausea, constipation or diarrhea, dryness of the oral mucosa, headache, thirst, polyuria, fatigue, asthenia, manifested against the background of taking the drug. Late symptoms: pain in the bones, clouding of urine, increased blood pressure, hyperemia, conjunctiva, eye photosensitivity, arrhythmia, drowsiness, itching, pancreatitis.

    When there are signs of hypercalcemia immediately consult a doctor.

    Chronic overdose is possible in adults when taking the drug for several weeks or months at a dose exceeding 1.0 mg (33 drops) per day. In some patients, an overdose can be observed at a lower dose. In chronic overdose, hypercalciuria may be increased.

    A prolonged increase in the level of calcium in the blood can lead to impaired renal function, development of urolithiasis, calcification of soft tissues and kidneys. Calcium can be deposited in many tissues, including arteries and kidneys, which leads to increased blood pressure and kidney failure. Calcium can also occur in the heart, lungs, skin.In rare cases, there are changes in the cornea of ​​the eyes, damage to the teeth. A hypercalcemic crisis with dehydration, stupor, coma and azotemia is possible. In case of an overdose, the drug is canceled. Recommended abundant drink, a diet with a low calcium content, laxatives.

    With a hypercalcemic crisis, an intravenous solution of 0.9% sodium chloride solution is administered, possibly with the addition of loop diuretics (furosemide or ethacrynic acid). Diuresis should be controlled and maintained at> 3 ml / kg / h during the acute stage of treatment. Other measures to treat persistent cases of drug-induced hypercalcemia may include the administration of bisphosphonates, calcitonin, colestyramine, citrates or corticosteroids, hemodialysis.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Interaction:
    With simultaneous administration of dihydrotachysterol with other compounds of the vitamin D group, as well as with preparations and dietary supplements containing calcium, thiazide diuretics and rifampicin,possibly the development of hypercalcemia.

    With simultaneous reception with drugs containing magnesium, the occurrence of hypermagnesia is possible.

    Dihydrotachysterol enhances the action of cardiac glycosides and blockers of "slow" calcium channels. When the cardiac glycosides or blockers of "slow" calcium channels are simultaneously taken with dihydrota- hysterol, a dose of the latter can be reduced. Hypercalcemia caused by an overdose of dihydrotachysterol may increase the toxic effects of cardiac glycosides.

    Barbiturates (phenobarbital), antiepileptic drugs [phenytoin, carbamazepine, primidon] weaken the action of dihydrotachysterol due to increased metabolism into inactive metabolites.

    Anion exchange resins (colestramine, colestipol) and vaseline oil weaken the pharmacological effect of the drug by reducing absorption in the gastrointestinal tract.

    Drugs that inhibit osteoclastic bone resorption, such as calcitonin and bisphosphonates, reduce the hypercalcemic effect of dihydrotachysterol.

    If against the background of taking dihydrochysterol, simultaneous treatment with thyroxine is carried out, then after its cancellation the development of hypercalcemia is possible.
    Special instructions:

    During the course of treatment, it is necessary to control the calcium and phosphorus content in serum and urine at least once a month at the initial stage of treatment, and after selecting the optimal dose and stabilizing the patient's condition - at least once every three months. The serum calcium level should be maintained between 1.9 and 2.5 mmol / L, preferably at the lower limit of this range. If the product of total serum calcium by inorganic phosphorus serum [Catotal(mmol / L) x Pneorg (mmol / l)] will exceed 6, the drug should be stopped immediately before the restoration of normocalcemia.

    The drug should be administered with caution to patients with ischemic heart disease and impaired renal function, especially with secondary hyperparathyroidism. In renal osteodystrophy with hyperphosphatemia, there is a high risk of metastatic calcification, so dihydrotachysterol appoint only when the concentration of phosphate in the blood is normalized.

    It is necessary to monitor the level of calcium in elderly patients with a dramatic change in diet and motor activity.

    Hypercalcemia or hypercalciuria can be corrected by abolishing the drug and reducing calcium intake prior to the normalization of the conthe concentration of calcium in the blood serum. Typically, this period is 1 week. Then the therapy can be continued, starting with half the last applied dose.

    The action of dihydrotachysterol can continue for 1-2 months after discontinuation.

    Data on the negative effect of dihydrotachysterol in driving and working with moving mechanisms have not been identified.

    Effect on the ability to drive transp. cf. and fur:
    Drops for ingestion in oil, 1 mg / ml.
    Form release / dosage:
    In bottles of orange glass for 10, 15, or 20 ml, capped with lids with droppers.

    Packaging:
    4 years. Do not use after the expiration date printed on the package.

    Storage conditions:
    In the dark place at a temperature of no higher than 25 ° C in an upright position. Keep out of the reach of children!

    Shelf life:
    4 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001527 / 01
    Date of registration:06.10.2008
    The owner of the registration certificate:NPK ECHO, CJSC NPK ECHO, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp20.01.2016
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