Aquadetrim vitamin d3

Aquadetrim vitamin d3 is a medicine containing calciferol and its analogues.

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Indications Vitamin d3 aquadetrim.

It is used for the following disorders:

• prevention of rickets development;
• prevention of cholecalciferol deficiency in high-risk individuals who do not have absorption disorders;
• prevention of rickets in newborns born prematurely;
• prevention of cholecalciferol deficiency in malabsorption;
• therapy for osteomalacia or rickets;
• supportive therapy for osteoporosis;
• for the treatment of hypoparathyroidism.

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Release form

The product is sold in an aqueous solution for oral use, in 10 ml bottles. A separate box contains 1 such glass bottle.

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Pharmacodynamics

Cholecalciferol is an active anti-rachitic factor. The main and most important function of calciferol is to stabilize the exchange processes of phosphates with calcium, due to which the growth and mineralization of the skeleton proceeds correctly.

Cholecalciferol is a natural form of calciferol produced by human and animal organisms. Compared to ergocalciferol, its activity is higher – by 25%.

The substance is required for the stable functioning of the parathyroid glands, kidneys, and intestines with the skeletal system. It is important in the processes of absorption of phosphates with calcium from the intestine, in the movement of mineral salts and in bone calcification. In addition, it stabilizes the process of excretion of phosphates and calcium through the kidneys.

The amount of calcium ions affects many biochemical processes necessary for the body, which help maintain muscle tone of the skeletal muscles, are participants in the transmission of neural impulses and affect blood clotting. Cholecalciferol is also a participant in the immune system, and in addition, affects the production of lymphokines.

A deficiency of cholecalciferol in the food consumed and a deterioration in its absorption, as well as a lack of calcium and a lack of exposure to sunlight during the stage of accelerated growth of the child, cause rickets. In adults, osteomalacia develops, and in pregnant women, signs of tetany appear. Also, due to such disorders observed in the mother during pregnancy, infants do not develop tooth enamel later.

Women in menopause, who often suffer from osteoporosis due to hormonal imbalances, need to increase their dose of cholecalciferol.

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Pharmacokinetics

Absorption.

The aqueous solution of cholecalciferol has a higher absorption than the oil solution. It is necessary to take into account that premature infants have insufficient formation and passage of bile inside the intestine, due to which the absorption of vitamin substances in oil solutions is impaired.

When taken orally, the active element is absorbed, entering the small intestine.

Distribution processes.

The drug passes into breast milk and through the placenta.

Exchange processes.

The drug is metabolized in the kidneys and liver, where it is transformed into an active decay product - the substance calcitriol, which is synthesized with carrier proteins and moves to the target organ area (bones with intestines and kidneys). The half-life in the blood is several days (in case of renal pathologies it can increase).

Excretion.

Excreted in feces and urine.

Cholecalciferol begins to affect the metabolism of calcium and phosphorus 6 hours after taking the drug.

48 hours after taking cholecalciferol, a significant increase in its levels in the blood serum is observed.

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Dosing and administration

The medication is taken orally.

To prevent the development of rickets, and also to prevent the development of cholecalciferol deficiency in people from high-risk groups who do not have absorption disorders, one drop of the medicine should be taken per day (approximately 500 IU of cholecalciferol).

Maintenance therapy for osteoporosis includes taking 2 drops of the drug per day (approximately 1000 IU of cholecalciferol).

To prevent rickets in premature infants, the portion sizes should be selected by a doctor. The recommended total dose is usually 2 drops per day (approximately 1000 IU of cholecalciferol).

When preventing the development of cholecalciferol deficiency due to malabsorption, the dosage is selected by the attending physician. Often, the total recommended dose is 6-10 drops of the medication per day (approximately 3000-5000 IU of cholecalciferol).

Therapy for osteomalacia or rickets: the dose is selected individually for each patient, taking into account the severity of the disease and its course. The total daily dose for cholecalciferol deficiency (in children or infants) is approximately 2-10 drops (approximately 1000-5000 IU of cholecalciferol).

Treatment for hypoparathyroidism involves selecting a dose based on the calcium levels in the blood serum - often it is 20-40 drops per day (approximately 10,000-20,000 IU of cholecalciferol). If the need for cholecalciferol is higher, the dose of the medication can be increased.

During long-term treatment with Aquadetrim, it is necessary to constantly monitor the calcium values in the urine with blood serum. If necessary, the dosage is adjusted taking into account the serum calcium values.

Duration and pattern of use.

For children, the drug is used to prevent rickets - it is taken from the 14th day of life until the end of the first 12 months. In the 2nd year of life, the need to continue taking the drug may develop, especially in winter.

For a small child, the drops are added to milk, regular water or baby food (a teaspoon is required). When adding the substance to a plate or a bottle with baby formula, you need to make sure that the child has eaten everything completely, otherwise it will not be possible to guarantee the consumption of the entire portion of the drug. The medicine should be added to food before starting to take it.

An older child or adult should take the drops by mixing them with some liquid on a spoon.

The duration of the treatment cycle depends on the intensity of the pathology and its progression, and it should be selected by a doctor. In case of osteomalacia or rickets caused by a lack of cholecalciferol, the therapy lasts 12 months.

If the patient takes more than 1000 IU of cholecalciferol per day, or with continuous use of the drug, serum calcium levels should be monitored.

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Use Vitamin d3 aquadetrim. during pregnancy

During lactation and pregnancy, a woman's body must receive a sufficient amount of calciferol. At the same time, it is necessary to control the process of its intake.

No more than 500 IU of calciferol should be taken per day. There is no data on the development of risks when taking the vitamin within the specified dosage. It is necessary to avoid prolonged overdose of calciferol, because it can cause hypercalcemia, which leads to the occurrence of abnormalities in the mental and physical development of the fetus, aortic stenosis and retinopathy in the child.

Prescribing Aquadetrim vitamin D3 during pregnancy is permitted only under strict indications, with strict adherence to all recommendations regarding the dosage portion.

Calciferol and its breakdown products pass into breast milk. There is no information regarding possible overdose.

Contraindications

Main contraindications:

• the presence of intolerance to medicinal components;
• hypervitaminosis D;
• hypercalcemia or hypercalciuria;
• pulmonary sarcoidosis;
• renal failure;
• tuberculosis or nephrolithiasis;
• Albright's disease (the body's need for calciferol may be lower than with normal tolerance of the vitamin).

Consumption of calciferol may provoke intoxication. To facilitate control over its indicators, the vitamin should be taken in other forms of release.

The drug should not be prescribed to people with a rare form of hereditary fructosemia, as well as with glucose-galactose or sucrose-isomaltose malabsorption.

Side effects Vitamin d3 aquadetrim.

The use of the drug may provoke the development of the following side effects:

• disorders of the cardiovascular system: increased blood pressure or arrhythmia;
• digestive disorders: nausea, constipation, bloating, diarrhea and vomiting, as well as abdominal pain, loss of appetite, dyspeptic symptoms and dry mouth;
• problems with the functioning of the nervous system: feeling of drowsiness, depression, mental disorder, headaches;
• disorders affecting the urinary system: increased calcium levels in the urine or blood, polyuria, urolithiasis and tissue calcification, as well as uremia;
• epidermal lesions: symptoms of intolerance, including itching, urticaria and rashes;
• disorders of the musculoskeletal system: the appearance of muscle weakness, arthralgia or myalgia;
• problems affecting the visual organs: photosensitivity or conjunctivitis;
• metabolic disorders: weight loss, hypercholesterolemia, hyperhidrosis, and pancreatitis;
• disorders associated with the hepatobiliary system: increased activity of aminotransferases;
• mental disorders: decreased libido;
• Others: the appearance of hyperthermia or rhinorrhea.

Due to the benzyl alcohol contained in the drug (ratio 15 mg/ml), anaphylactoid symptoms may occur.

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Overdose

Cholecalciferol stabilizes the exchange processes of phosphates with calcium, and poisoning with it leads to the appearance of hypercalciuria or hypercalcemia, and in addition to this, to bone damage, the development of renal calcifications and disturbances in the work of the cardiovascular system. The development of hypercalcemia begins with the use of 50,000-100,000 IU of the substance per day.

Intoxication may cause the following adverse symptoms: loss of appetite, photosensitivity, muscle weakness, vomiting, drowsiness, pancreatitis, nausea, and constipation. In addition, polyuria, rhinorrhea, polydipsia with hyperthermia and conjunctivitis appear, libido decreases, hypercholesterolemia, uremia, or cardiac arrhythmia occurs, blood pressure and transaminase activity increase. Frequently encountered disorders include headaches, muscle or joint pain, and weight loss. Renal dysfunction develops, accompanied by albuminuria, polyuria, and erythrocyturia, as well as nocturia, potassium loss, moderate increase in blood pressure, and hyposthenuria.

In severe poisoning, corneal opacity may occur, and in addition, more rarely, swelling of the papilla in the area of the optic nerve or inflammation of the iris, sometimes leading to cataracts.

Kidney stones and calcification of soft tissue areas (heart, blood vessels, and epidermis with lungs) may occur. Cholestatic jaundice is occasionally observed.

In case of poisoning, hypercalcemia must be treated. First, the drug must be discontinued, and then, taking into account the intensity of hypercalcemia development, a diet with a small amount of calcium or without it at all is prescribed. In addition, it is necessary to drink a lot of fluids, take calcitonin with GCS, and also administer furosemide to induce forced diuresis.

If the kidneys are functioning properly, calcium levels can be reduced by administering an infusion of NaCl solution (3-6 liters of the substance are needed over 24 hours) in combination with furosemide. Sometimes sodium B is used (at a rate of 15 mg/kg/hour) along with constant monitoring of ECG and calcium values. When treating oliguria, a hemodialysis session is necessary.

The drug has no antidote.

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Interactions with other drugs

Anticonvulsants (eg, phenobarbital with phenytoin) and rifampicin reduce the absorption of Aquadetrim.

When combining the drug with thiazides, the likelihood of hypercalcemia increases.

Combined use with SG may increase their toxic properties (due to this, the likelihood of cardiac arrhythmia increases).

The combination of the drug with aluminum- or magnesium-containing antacids may lead to the development of aluminum toxicity in relation to bones, as well as hypermagnesemia in people with renal insufficiency.

Ketoconazole is able to weaken the catabolism and biosynthesis of cholecalciferol.

The combined use of cholecalciferol with metabolic products or calciferol analogues is permissible only as an exception and only under the condition of monitoring serum calcium levels (because the likelihood of toxic symptoms increases).

Combination with medications containing large amounts of phosphorus or calcium increases the likelihood of developing hyperphosphatemia.

Calciferol can act as an antagonist of drugs used for hypercalcemia (including etidronate, calcitonin and pamidronate).

Concomitant use with drugs that reduce weight (eg, orlistat) and cholesterol levels may lead to decreased absorption of calciferol and other fat-soluble vitamins.

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Storage conditions

Aquadetrim should be kept in a dark place, out of reach of small children. Temperature level should not exceed 25°C.

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Shelf life

Aquadetrim vitamin d3 is allowed to be used within 36 months from the date of manufacture of the therapeutic agent. An opened, tightly sealed bottle has a shelf life of 0.5 years.

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Application for children

The medicine can be prescribed to infants from the 14th day of life.

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Analogues

The analogs of the drug are Vigantol, Alpha-D3, Videin and Alfaphorcal with Alfaphorcal plus, and in addition to this Plivit, Tridevita, Ideos with Takhistin, Ergocalciferol and Forcal together with Forcal plus.

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