Instructions for use Aquavit-D3 oral solution 375 mcg/ml bottle 10 ml
Composition
active ingredient: cholecalciferol (vitamin D3);
1 ml of solution contains cholecalciferol (vitamin D3) 375 mcg (15,000 IU);
Excipients: polyethoxylated castor oil; white crystalline sugar; sodium hydrogen phosphate dodecahydrate; citric acid monohydrate; benzyl alcohol; anise flavoring; purified water.
Dosage form
Oral solution.
Main physicochemical properties: transparent colorless liquid with a characteristic anise odor. Opalescence is allowed.
Pharmacotherapeutic group
Vitamins. Vitamin D preparations and its analogues. Cholecalciferol. ATX code A11C C05.
Pharmacological properties
Pharmacodynamics.
Vitamin D3 is an active anti-rickets factor. The most important function of vitamin D3 is the regulation of calcium and phosphate metabolism, which contributes to proper mineralization and skeletal growth.
Vitamin D3 is the natural form of vitamin D produced in animals and humans. It has a higher activity (25%) than vitamin D2.
It is necessary for the functioning of the parathyroid glands, intestines, kidneys and bone system. It plays a significant role in the absorption of calcium and phosphates from the intestines, in the transport of mineral salts and in the process of bone calcification, regulates the excretion of calcium and phosphates by the kidneys. The concentration of calcium ions affects a number of important biochemical processes that determine the maintenance of skeletal muscle tone, participate in the conduction of nervous excitation and affect blood clotting. Vitamin D3 is also involved in the functioning of the immune system, affecting the production of lymphokines.
Lack of vitamin D3 in food, impaired absorption, calcium deficiency, and lack of exposure to sunlight during the period of rapid growth of a child leads to rickets, and in adults - to osteomalacia, in pregnant women - to the appearance of symptoms of tetany, and later - to the lack of tooth enamel formation in children.
Women in menopause who suffer from osteoporosis need to increase their dose of vitamin D3 due to hormonal imbalances.
Pharmacokinetics.
Absorption. An aqueous solution of vitamin D3 is better absorbed than an oil solution. In premature babies, insufficient bile formation and flow to the intestines occurs, which disrupts the absorption of vitamins in the form of oil solutions.
After oral administration, cholecalciferol is absorbed in the small intestine.
Distribution: Penetrates the placental barrier and into breast milk.
Metabolism. Metabolized in the liver and kidneys, turning into an active metabolite - calcitriol, which combines with a carrier protein and is transported to target organs (intestine, bones, kidneys). The half-life in the blood is several days and may be prolonged in case of kidney disease.
Excretion: Excreted in urine and feces.
Vitamin D3 is involved in the regulation of phosphorus and calcium metabolism in the body 6 hours after taking the drug.
After taking vitamin D3, a significant increase in the level of cholecalciferol in the blood serum is observed within 48 hours.
Indication
Prevention of rickets;
prevention of vitamin D3 deficiency in high-risk groups who do not have absorption disorders;
prevention of rickets in premature newborns;
prevention of vitamin D3 deficiency in malabsorption;
treatment of rickets and osteomalacia;
supportive treatment of osteoporosis.
Contraindication
Hypersensitivity to the components of the drug, hypercalcemia and/or hypercalciuria, hypervitaminosis D, sarcoidosis, renal failure, nephrolithiasis, tuberculosis.
Pseudohypoparathyroidism (vitamin D requirements may be lower than during normal vitamin sensitivity). Taking vitamin D may lead to a risk of overdose. In such situations, vitamin D should be used in other dosage forms to make it easier to control the concentration. The drug is contraindicated in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Interaction with other medicinal products and other types of interactions
Antiepileptic drugs, especially phenytoin and phenobarbital, as well as rifampicin, neomycin, cholestyramine, liquid paraffin reduce the effect of vitamin D3.
Concomitant use with thiazides increases the risk of hypercalcemia.
Concomitant use with cardiac glycosides may enhance their toxic effects (increased risk of cardiac arrhythmia).
Concomitant use of the drug with antacids containing aluminum or magnesium may provoke aluminum toxicity on bones and hypermagnesemia in patients with renal failure.
Ketoconazole may reduce the biosynthesis and catabolism of 1,25(OH)2–cholecalciferol.
Simultaneous administration of vitamin D3 with metabolites or analogues of vitamin D is possible only as an exception and only under the condition of monitoring the level of calcium in the blood serum (the risk of toxic effects increases).
Concomitant use with drugs containing high doses of calcium or phosphorus increases the risk of hyperphosphatemia.
Concomitant use with weight loss drugs (orlistat) and cholesterol-lowering drugs may reduce the absorption of vitamin D and other fat-soluble vitamins.
Application features
The drug should be used with caution in immobilized patients, patients taking thiazides, cardiac glycosides, and patients with cardiovascular diseases.
When using the drug, it is necessary to take into account the additional intake of vitamin D3 (concurrent use of other drugs containing vitamin D). Combination therapy with vitamin D or calcium should be carried out only under the supervision of a physician, monitoring the level of calcium in the blood serum and urine.
Individual provision of a specific need must take into account all possible sources of this vitamin.
Very high doses of the drug used for a long time, or shock doses, can cause chronic hypervitaminosis D3.
Determining a child's daily need for vitamin D and the method of its use should be established individually and verified each time during periodic examinations, especially in the first months of life.
The drug should be used with particular caution in infants born with a small anterior fontanelle.
Do not take the drug simultaneously with high doses of calcium.
During treatment with the drug, monitoring of calcium, phosphate, and sugar levels in blood serum and urine is recommended.
The drug should be used with caution in patients with impaired renal function. Long-term use of the drug requires monitoring of renal function by serum creatinine levels.
The drug should be used with caution in pregnant and breastfeeding women.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, vitamin D intake should be monitored.
Daily doses up to 500 IU of vitamin D. The risks of using vitamin D in this dose range are unknown. Long-term overdose of vitamin D should be avoided due to the possible development of hypercalcemia.
Daily doses of more than 500 IU of vitamin D. The drug should be used during pregnancy only in case of urgent need in strictly recommended dosage. Long-term overdose of vitamin D should be avoided due to the possible development of hypercalcemia, which leads to defects in physical and mental development of the fetus, aortic stenosis and retinopathy in children.
Vitamin D and its metabolites pass into breast milk. There is no data on possible overdose.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are currently no reports of the drug's harmful effects on the ability to drive or operate other mechanisms. However, it is recommended to exercise extreme caution when driving or operating other mechanisms due to possible adverse reactions from the nervous system.
Method of administration and doses
Administer orally.
Prevention of rickets: the recommended dose is 1 drop (about 500 IU of vitamin D3) per day.
Prevention of vitamin D3 deficiency in high-risk patients without malabsorption: the recommended dose is 1 drop (approximately 500 IU of vitamin D3) per day.
Maintenance treatment of osteoporosis: the recommended dose is 2 drops (approximately 1000 IU of vitamin D3) per day.
Prevention of rickets in premature newborns: the dose is determined by the doctor. The total recommended dose is 2 drops (about 1000 IU of vitamin D3) per day.
Prevention of vitamin D3 deficiency in malabsorption: the dose is determined individually by the doctor. The total recommended dose is 6-10 drops (about 3000-5000 IU of vitamin D3) per day.
Treatment of rickets and osteomalacia: the dose is determined by the doctor individually depending on the course and severity of the disease. The total recommended dose for the treatment of vitamin D3 deficiency for infants and children is 2-10 drops (about 1000-5000 IU of vitamin D3) per day. The dose for the treatment of vitamin D3 deficiency is determined by the doctor individually depending on the course and severity of the disease.
During long-term treatment with the drug, it is necessary to regularly monitor the level of creatinine in the blood and the level of calcium in the blood serum and urine. If necessary, the dose should be adjusted depending on the concentration of calcium in the blood serum.
Duration and method of application.
Children are prescribed the drug for the prevention of rickets, starting from the second week of life until the end of the first year of life. During the second year of life, further use of the drug may be necessary, especially in winter.
For young children, give the drops in a teaspoon of water, milk or baby food. If the drops are added to a feeding bottle or plate, it is necessary to ensure that the food is completely consumed, otherwise it is not possible to guarantee that the entire dose of the drug is taken. Add the drug to the food immediately before eating.
Adults and older children should take the drug in a spoonful with liquid.
1 drop contains 500 IU of vitamin D3. To accurately measure the dose of the drug, you need to hold the bottle at a 45° angle while instilling.
When using doses of more than 1000 IU of vitamin D3 per day, as well as with continuous use of the drug, serum calcium levels should be monitored.
Children.
It is used for children from the second week of life.
Overdose
Vitamin D3 regulates calcium and phosphate metabolism; overdose results in hypercalcemia, hypercalciuria, renal calcifications and bone damage, as well as changes in
Cardiovascular system. Hypercalcemia occurs after the use of 50,000-100,000 IU of vitamin D3 per day.
Overdose may cause the following effects: muscle weakness, loss of appetite, nausea, vomiting, constipation, polydipsia, polyuria, drowsiness, photosensitivity, pancreatitis, rhinorrhea, hyperthermia, decreased libido, conjunctivitis, hypercholesterolemia, increased transaminase activity, arterial hypertension, cardiac arrhythmia and uremia. Common symptoms are: muscle and joint pain, headache, weight loss. Renal dysfunction develops with albuminuria, erythrocyturia and polyuria, increased potassium loss, hyposthenuria, nocturia and moderate increase in blood pressure.
In severe cases, corneal clouding is possible, less often - swelling of the optic nerve papilla, inflammation of the iris, up to the development of cataracts.
Kidney stones and calcifications in soft tissues such as blood vessels, heart, lungs, and skin may form.
Cholestatic jaundice rarely develops.
Treatment. Overdose requires treatment of hypercalcemia. The drug should be discontinued. Depending on the degree of hypercalcemia, a low-calcium or calcium-free diet, plenty of fluids, forced diuresis induced by the administration of furosemide, and the administration of glucocorticoids and calcitonin are recommended.
With normal renal function, the calcium level is significantly reduced during the administration of an infusion solution of sodium chloride (3-6 liters over 24 hours) with the addition of furosemide, in some cases it is also necessary to use 15 mg/kg body weight/hour of sodium edetate, constantly monitoring the calcium level and ECG. In oligoanuria, on the contrary, hemodialysis is necessary. There is no specific antidote.
Side effects
Adverse reactions are usually not observed when using the drug in recommended doses.
In case of individual hypersensitivity to vitamin D3, which is rare, or in case of using too high doses for a long period, vitamin D hypervitaminosis may occur.
On the part of the digestive tract: loss of appetite, nausea, vomiting, constipation, dry mouth, flatulence, abdominal pain, diarrhea, dyspepsia.
From the nervous system: headache, drowsiness, mental disorders, depression.
From the urinary system: increased calcium levels in the blood and/or urine, urolithiasis and tissue calcification, uremia, polyuria.
Skin and subcutaneous tissue disorders: allergic reactions, including urticaria, rash, itching, eczema.
Musculoskeletal system: myalgia, arthralgia, muscle weakness.
From the organs of vision: conjunctivitis, photosensitivity.
Metabolic: hypercholesterolemia, weight loss, polydipsia, increased sweating, pancreatitis.
On the part of the hepatobiliary system: increased activity of aminotransferases.
On the part of the psyche: decreased libido.
There have also been reports of rhinorrhea, hyperthermia, and dry mouth.
Due to the content of benzyl alcohol (15 mg/ml), the drug may cause anaphylactoid reactions.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
After opening the bottle, store with the lid tightly closed in the refrigerator (at a temperature of 2 to 8 °C) for no more than 6 months.
Packaging
10 ml in a dark glass bottle. 1 bottle with a dropper stopper in a cardboard pack.
Vacation category
According to the recipe.
Producer
Technolog PJSC.
Location of the manufacturer and address of its place of business.
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
