D3-Droplet - instructions for use, doses, side effects, contraindications

Excipients: methyl parahydroxybenzoate 1.00 mg, butyl hydroxy toluene 0,10 mg, macrogol glyceryl hydroxy stearate 100,00 mg, macrogol-400 50.00 mg, propylene glycol 100.00 mg, citric acid anhydrous 1.25 mg, disodium hydrophosphate anhydrous 6.10 mg, sucralose 3.00 mg, water up to 1 ml.

Description:Colorless, clear or slightly opalescent solution.

Pharmacotherapeutic group:Calcium-phosphorus exchange regulator

ATX: & nbsp

A.11.C.C.05 Kolekaltsiferol

Pharmacodynamics:

A drug that regulates the exchange of calcium and phosphorus. Replenishes vitamin deficiency D₃. It enhances the absorption of calcium and phosphate ions in the intestine and their reabsorption in the renal tubules. Promotes the mineralization of bones and is necessary for the normal functioning of parathyroid glands.

Pharmacokinetics:

Suction. Absorption - fast from the distal part of the small intestine, enters the lymphatic system, enters the liver and into the general bloodstream.

Distribution. In the blood binds to α₂globulins and partially with albumins. Kolekaltsiferol accumulates in the liver, bones, skeletal muscles, kidneys, adrenals, myocardium, adipose tissue. The maximum concentration in tissues is reached in 4-5 hours, after that it decreases somewhat, remaining for a long time at a constant level. Cumulates. Penetrates through the placental barrier. Excreted in breast milk.

Metabolism. Biotransformation occurs in the liver and kidneys: in the liver colcalciferol is converted into an inactive metabolite, calciphediol (25-dihydrocolecalciferol), in the kidney - from calciphediol is converted to an active metabolite calcitriol (1,25-dihydroxycolecalciferol) and the inactive metabolite 24,25-dihydroxycolecalciferol. Undergoes intestinal-hepatic recirculation.

Excretion. The drug is produced mainly with bile and a small amount - kidneys.

Indications:

- Prevention of rickets in children, including with unbalanced diet (vitamin deficiency D), as well as with insufficient insolation in the winter.

- Prevention of vitamin deficiency D during pregnancy and during breastfeeding.

- Prevention of osteoporosis of various genesis.

Contraindications:

Hypercalcemia; hypercalciuria; pseudoparathyroidism; calcium nefrourolithiasis; thyrotoxicosis (probability of hypersensitivity); renal osteodystrophy with hyperphosphatemia; hypervitaminosis D; hypersensitivity to the components of the drug.

Carefully:

Atherosclerosis, heart failure, renal insufficiency, sarcoidosis or other granulomatosis, hyperphosphatemia, phosphate nephrourolythisis (including in the anamnesis), organic heart lesions, acute and chronic liver and kidney diseases, diseases of the gastrointestinal tract (GIT) (in including peptic ulcer of the stomach and duodenum), with hypothyroidism, during pregnancy and during breastfeeding, with the intake of additional amounts of vitamin D₃ (for example, as part of other drugs), immobilized patients, in infants, with a predisposition to early overgrowing of the fontanelles (when the small size of the anterior pubescence is established from birth).

Pregnancy and lactation:

Caution should be applied colcalciferol during pregnancy and during breastfeeding.

In case of overdose, hypercalcemia and transplacental penetration of vitamin metabolites may occur D₃in the fetus, which can lead to a teratogenic effect: retardation of mental and physical development of the fetus, special forms of aortic stenosis.

Vitamin D₃ penetrates into breast milk, this should be borne in mind when assigning it to children who are breastfeeding

During pregnancy and during breastfeeding, the daily dose of colcalciferol should not exceed the dose of 600 ME.

Dosing and Administration:

Inside, previously dissolved in a teaspoon of milk, juice or water.

One drop of the drug contains about 200 ME colcalciferol.

Newborns and children during the first year of life - 2-5 drops (400-1000 ME) per day in accordance with the recommendations of the attending physician.
Children over the age of 1, pregnant and women during breastfeeding - 2 drops (400 IU) per day.

The daily dose for children should not exceed 1000 ME.

The duration of the drug depends on the duration of pregnancy, breastfeeding, or the period of vitamin deficiency D and is determined by the attending physician.

For the prevention of osteoporosis - 2-5 drops (400-1000 ME) per day.

When using the drug is recommended to periodically monitor the concentration of calcium in the blood plasma.

Side effects:

Recommended doses of the drug D3-KApulea, as a rule, do not cause side effects.

From the digestive system: constipation, flatulence, nausea, abdominal pain, diarrhea, decreased appetite.

From the side of metabolism: hyperphosphatemia, hypercalcemia whose early symptoms are constipation, nausea, vomiting (more common in children), diarrhea, dryness of the oral mucosa, thirst, loss of appetite, weakness, headache, frequent urination and hypercalciuria in the case of taking the drug for a long time time in high doses (see section "Overdose"), polyuria.

From the musculoskeletal system: myalgia, arthralgia.

From the cardiovascular system: increased blood pressure, arrhythmias.

Allergic reactions: itchy skin, skin rash, hives.

Other: headache, impaired renal function, exacerbation of the tuberculous process in the lungs.

Overdose:

The dose that can cause toxic effects depends on individual sensitivity. Symptoms of overdose in adults can occur when administered at doses of 20,000 to 60,000 ME or more per day for several weeks or months, and in children - when applied at doses from 2000 to 4000 ME for several months, and also after a single application of a high dose of the drug.

Symptoms of hypervitaminosis D₃: early (due to hypercalcemia) - constipation or diarrhea, dryness of the oral mucosa, headache, thirst, pollakiuria, nocturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, fatigue, general weakness, adynamia, dehydration, hypercalcemia, hypercalciuria, an increase in plasma concentrations of 25-dihydrocolecalciferol; late pain in the bones, clouding of urine (the appearance of hyaline cylinders, proteinuria, leukocyturia in the urine), increased blood pressure, pruritus, photosensitivity of the eyes, congestion hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia, weight loss; rarely - changes in the psyche (up to the development of psychosis) and mood.

Symptoms of Chronic Overdose of Vitamin D₃: calcification of soft tissues, kidneys, lungs, blood vessels, increased blood pressure, renal and heart failure (these effects occur most often with adherence to hypercalcemia, hyperphosphataemia), growth disorders in children (prolonged intake at a dose of 1800 IU / day).

Treatment: in acute or chronic overdose it is necessary to carry out measures for the treatment of developing hypercalcemia. Depending on the degree of severity of hypercalcemia, the following measures are used: drug cancellation, low calcium diet, consumption of large amounts of liquid, use of glucocorticosteroids, vitamin E, ascorbic acid, retinol, thiamine, pantothenic acid, riboflavin; in severe cases - intravenous injection of 0.9% solution of sodium chloride, furosemide, electrolytes, hemodialysis, the introduction of calcitonin. There is no specific antidote.

To avoid overdose with the use of the drug is recommended to monitor the calcium content in the blood plasma.

Interaction:

Phenytoin, primidon and drugs of the barbiturate group can reduce the effectiveness of the vitamin D₃.

Simultaneous application of vitamin D₃ and antacids containing magnesium, can lead to the development of hypermagnesia.

Calcitonin, bisphosphonates (including etidronic, pamidronic acid), plikamycin reduce the effect.

Kolestyramine, colestipol, neomycin and mineral oil reduce the absorption of the vitamin D₃ from the gastrointestinal tract.

Increases the absorption of phosphorus-containing drugs and the risk of hyperphosphataemia.

When used simultaneously with sodium fluoride, the interval between the intake should not be less than 2 h, with oral forms of tetracyclines - not less than 3 hours.

When used simultaneously with glucocorticosteroids, the effectiveness of the drug may be reduced.

Simultaneous use with cardiac glycosides can increase their toxic potential due to the development of hypercalcemia. In such patients, it is necessary to monitor the calcium content, electrocardiogram and adjust the dose of cardiac glycosides.

Simultaneous use of benzodiazepine derivatives increases the risk of hypercalcemia.

Vitamin D₃ can be combined with metabolites or analogs of the vitamin D only in exceptional cases and under the control of the calcium content in the blood serum.

Simultaneous application of vitamin D₃ and drugs containing large doses of calcium or thiazide diuretics, increases the risk of hypercalcemia. In such patients it is necessary to carry out a constant monitoring of the calcium content in the blood plasma.

Rifampicin and isoniazid can reduce the effect of the drug because of the increased rate of biotransformation.

Special instructions:

Newborns who are breastfed, especially those born to mothers with dark skin and / or who have insufficient insolation, have a high risk of vitamin deficiency D.

Care should be taken when using the drug in infants who are breastfeeding, because they may have increased sensitivity to vitamin A D.

The daily dose for children should not exceed 1000 ME.

In the elderly, the need for a vitamin D may increase due to decreased absorption of the vitamin D, reducing the ability of the skin to synthesize provitamin D₃, a decrease in the time of insolation, an increase in the incidence of renal failure.

Care should be taken when using the drug in patients with impaired renal function, urolithiasis, cardiovascular diseases due to an increased risk of hypercalcemia.

It is recommended to use the drug under the control of calcium in the blood and urine, especially when used with thiazide diuretics.

Consider the total intake of vitamin A D from all sources (vitamins, milk with the addition of vitamin D, fish oil, fish and eggs, which are a natural source of vitamin D) in order to avoid excessive intake of colcalciferol in the body.

With prolonged use of the vitamin D in doses exceeding 1000 ME per day, it is necessary to regularly monitor the concentration of calcium in the blood plasma.

Effect on the ability to drive transp. cf. and fur:

Data on the impact on the ability to drive vehicles and work with mechanisms are not available.

Form release / dosage:

Drops for oral administration, 4000 IU / ml.

Packaging:

For 10 ml in bottles of dark glass with a built-in polyethylene stopper-dropper and a screwed polypropylene lid.

1 bottle with instructions for use in a cardboard box.

Storage conditions:

Store in a dark place at a temperature of 2 ° C to 8 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

The open vial is 100 days.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003990

Date of registration:01.12.2016

Expiration Date:01.12.2021

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Operations Poland, Sp. z o.o. Poland

Representation: & nbspTeva Teva Israel

Information update date: & nbsp17.03.2017

Illustrated instructions

Instructions

D3-Drop (D3-Kapelka)