Videoin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIDEYIN (VIDEYIN)

Composition:

Active ingredient: cholecalciferol;

1 capsule contains cholecalciferol 12.5 mcg (vitamin D3 – 500 IU) or 25 mcg (vitamin D3 – 1000 IU) or 100 mcg (vitamin D3 – 4000 IU);

Excipients: α-tocopherol acetate; medium-chain triglycerides;

Capsule shell: gelatin, glycerin.

Pharmaceutical form. Soft capsules.

Main physicochemical properties:

Capsules of 12.5 mcg (500 IU): soft gelatin capsules in the shape of a tubatin, with an elongated neck in the form of a "fish tail", with a seam, light yellow in color, filled with a colorless or slightly yellowish oily liquid;

Capsules of 25 mcg (1000 IU): soft gelatin capsules in the shape of a "bottle", with a seam, light yellow in color, filled with a colorless or slightly yellowish oily liquid;

Capsules of 100 mcg (4000 IU): soft gelatin capsules of oval shape, with a seam, light yellow in color, filled with a colorless or slightly yellowish oily liquid.

Pharmacotherapeutic group. Vitamins. Vitamin D and its analogues. Cholecalciferol. ATC code A11CC05.

Pharmacological properties.

Pharmacodynamics.

Vitamin D3 is the active antirachitic factor. The most important function of vitamin D3 is the regulation of calcium and phosphate metabolism, promoting proper skeletal mineralization and growth.

Vitamin D3 is a natural form of vitamin D produced in animals and humans. Compared to vitamin D2, it has approximately 25 % higher activity. The active form is calcitriol (1,25-dihydroxy-vitamin D3), the product of two consecutive hydroxylations occurring in the liver and kidneys.

Vitamin D3 is essential for the proper function of the parathyroid glands, intestines, kidneys, and skeletal system. It plays a crucial role in the absorption of calcium and phosphates from the intestine, in the transport of mineral salts, and in the process of bone calcification. It also regulates the renal excretion of calcium and phosphates. Calcium ion concentration influences numerous vital biochemical processes, maintaining skeletal muscle tone, participating in nerve impulse conduction, and affecting blood coagulation. Vitamin D3 also contributes to immune system function and influences lymphokine production.

Deficiency of vitamin D3 in the diet, impaired absorption, calcium deficiency, and lack of exposure to sunlight during periods of rapid growth in children lead to rickets; in adults, to osteomalacia; and in pregnant women, to symptoms of tetany, followed by defective enamel formation in children.

Postmenopausal women suffering from osteoporosis due to hormonal disturbances require an increased dose of vitamin D3.

Pharmacokinetics.

Absorption. After oral administration, cholecalciferol is absorbed in the small intestine. The presence of bile facilitates absorption. Therefore, impaired liver or gallbladder function and steatorrhea may interfere with vitamin D3 absorption.

Distribution. Crosses the placental barrier and is excreted into breast milk.

Metabolism. Metabolized in the liver and kidneys into active metabolites. Calcifediol (25-hydroxy-vitamin D3), the product of hepatic hydroxylation of vitamin D3, is the major circulating form of the vitamin, with a half-life of approximately 19 days.

Calcitriol (1,25-dihydroxy-vitamin D3), formed by renal hydroxylation of calcifediol (25-hydroxy-vitamin D3), has a half-life of 3 to 5 days, which may be prolonged in renal disease. It is excreted mainly via bile.

Calcitriol is the active metabolite that binds to a carrier protein and is transported to target organs (intestines, bones, kidneys). Its half-life in blood is several days and may be prolonged in renal disease.

Excretion. Eliminated via urine and feces.

Clinical characteristics.

Indications.

• For the prevention of rickets, including in premature newborns;
• for the prevention of vitamin D3 deficiency in high-risk patients who do not have absorption disorders;
• for the prevention of vitamin D3 deficiency in malabsorption;
• for the treatment of rickets and osteomalacia;
• for maintenance treatment of osteoporosis.

Contraindications.

Hypersensitivity to components of the drug, hypercalcemia and/or hypercalciuria, idiopathic neonatal hypercalcemia, hypervitaminosis D, sarcoidosis, renal insufficiency, nephrolithiasis, urolithiasis, tuberculosis.

Pseudohypoparathyroidism (vitamin D requirement may be lower than during normal vitamin sensitivity).

Interaction with other medicinal products and other types of interactions.

Antiepileptic agents, especially phenytoin and phenobarbital, as well as rifampicin, neomycin, cholestyramine, and 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 arrhythmias).

Concomitant use of the drug with antacids containing aluminum or magnesium may provoke toxic effects of aluminum on bones and hypermagnesemia in patients with renal insufficiency.

Ketoconazole may reduce the biosynthesis and catabolism of 1,25(OH)2—cholecalciferol.

Concomitant administration of vitamin D3 with metabolites or analogs of vitamin D is possible only as an exception and only under monitoring of serum calcium levels (increased risk of toxic effects).

Concomitant use with medicinal products containing high doses of calcium or phosphorus increases the risk of hyperphosphatemia.

Vitamin D may antagonize medicinal products used in hypercalcemia, such as calcitonin, etidronate, pamidronate.

Concomitant use with weight-reducing agents (orlistat) and cholesterol-lowering drugs may reduce the absorption of vitamin D and other fat-soluble vitamins.

Glucocorticoid therapy may affect vitamin D metabolism.

Special precautions for use

The medicinal product should be used with caution in immobilized patients, patients taking thiazides, cardiac glycosides, and in patients with cardiovascular diseases.

When using the medicinal product, additional intake of vitamin D3 should be taken into account (concomitant use of other preparations containing vitamin D). Combined therapy with vitamin D or calcium should be administered only under medical supervision, with monitoring of calcium levels in blood serum and urine.

Individual requirements should take into account all possible sources of vitamin D intake.

It should be noted that a diet high in fats may increase the absorption of vitamin D3; therefore, during administration of the medicinal product, a diet low in excess fat is recommended.

Very high doses used long-term or bolus doses may cause chronic vitamin D3 hypervitaminosis.

The determination of a child's daily requirement for vitamin D and the method of administration should be established individually and verified periodically, especially during the first months of life.

The medicinal product should be used with particular caution in infants born with a small anterior fontanelle.

Do not take the medicinal product simultaneously with high doses of calcium.

During treatment with the product, monitoring of calcium and phosphate levels in blood serum and urine is recommended.

The medicinal product should be used with caution in patients with impaired renal function. Long-term use of the product requires monitoring of kidney function by measuring serum creatinine levels.

Treatment should be discontinued if symptoms of hypervitaminosis appear: fatigue, nausea, diarrhea, polyuria.

Use during pregnancy or breastfeeding

The medicinal product should be used with caution in pregnant and breastfeeding women.

During pregnancy or breastfeeding, vitamin D should be supplied in adequate amounts. Intake of vitamin D into the body should be monitored.

Daily doses up to 500 IU of vitamin D. Risks associated with the use of vitamin D within this dosage range are unknown. Prolonged vitamin D overdose should be avoided due to the potential risk of hypercalcemia.

Daily doses exceeding 500 IU of vitamin D. The medicinal product should be used during pregnancy only if strictly indicated and at strictly recommended doses. Prolonged vitamin D overdose should be avoided due to the potential risk of hypercalcemia, which may lead to physical and mental developmental disorders in the fetus, aortic stenosis, and retinopathy in children.

Vitamin D and its metabolites pass into breast milk; therefore, during breastfeeding, the product should be used only as prescribed by a physician.

There are no data regarding possible overdose.

Ability to influence reaction speed when driving vehicles or operating machinery

There are no reports indicating that the medicinal product affects the ability to drive vehicles or operate machinery. However, when driving vehicles or operating machinery, particular caution is recommended due to the potential occurrence of adverse reactions affecting the nervous system.

Method of Administration and Dosage

The medicinal product is administered orally.

For adults and older children (who are able to swallow the capsule), take the product orally before or during a meal: swallow the capsule whole with a sufficient amount of water (Fig. 1).

(Fig. 1)

For use in infants from the second week of life or in adults and older children who cannot swallow the capsule, squeeze the capsule contents into a spoon (container) (Fig. 2) with liquid (milk, fruit juice) or other food.

The capsule contents may also be added to a bottle or plate of food, but it is essential to ensure complete consumption of the food—otherwise, the full dose of the medicinal product cannot be guaranteed. Add the medicinal product to food immediately before consumption.

How to release the capsule contents

Prepare a clean spoon (container) (Fig. 2).

Before expressing the capsule contents into a clean spoon (container), thoroughly wash and dry hands.

With two fingers of one hand, hold the capsule by the tail (for "fish") or neck (for "bottles") and press gently so that the liquid flows into the body of the capsule (Fig. 3).

With two fingers of the other hand, slightly stretch and firmly squeeze the capsule neck (Fig. 4).

Slowly twist the tail or neck until it detaches (Fig. 5). Pay attention to the neck to prevent the contents from squirting out during unscrewing.

After opening the capsule, fully squeeze the liquid into the previously prepared clean spoon (container) (Fig. 6).

(Fig. 2) (Fig. 3) (Fig. 4) (Fig. 5) (Fig. 6)

Prevention of rickets: The recommended dose is 1 capsule containing 12.5 mcg (500 IU of vitamin D3) daily. Administer as shown in Figs. 2–6, by adding the capsule contents to liquid or food as described above.

Prevention of rickets in preterm newborns: The dose is determined by the physician. The general recommended dose is 2 capsules of 12.5 mcg or 1 capsule of 25 mcg (1000 IU of vitamin D3) daily. Administer as shown in Figs. 2–6, by adding the capsule contents to liquid or food as described above.

Prevention of vitamin D3 deficiency in high-risk patients without malabsorption disorders: The recommended dose is 1 capsule of 12.5 mcg (500 IU of vitamin D3) daily. The capsule may be swallowed whole or its contents added to liquid or food as described above.

Prevention of vitamin D3 deficiency in malabsorption: The dose is individually determined by the physician. The general recommended dose is 6–10* capsules of 12.5 mcg or 3–5* capsules of 25 mcg (3000–5000 IU of vitamin D3) daily. If the physician prescribes a dose of 4000 IU of vitamin D3, administer 1 capsule of 100 mcg (4000 IU of vitamin D3) daily. The capsule may be swallowed whole or its contents added to liquid or food as described above.

Treatment of rickets and osteomalacia: The dose is individually determined by the physician depending on the course and severity of the disease. The general recommended dose for treatment of vitamin D3 deficiency in infants and children is 2–10* capsules of 12.5 mcg (1000–5000 IU of vitamin D3) or 1–5* capsules of 25 mcg (1000–5000 IU of vitamin D3) daily. If the physician prescribes a dose of 4000 IU of vitamin D3, administer 1 capsule of 100 mcg (4000 IU of vitamin D3) daily.

Administer by adding the capsule contents to liquid or food as described above. Treatment lasts for one year.

Maintenance treatment of osteoporosis: The recommended dose is 2 capsules of 12.5 mcg (1000 IU of vitamin D3) or 1 capsule of 25 mcg (1000 IU of vitamin D3) daily. The capsule may be swallowed whole or its contents added to liquid or food as described above.

Duration of treatment.

The duration of treatment depends on the course and severity of the disease and is individually determined by the physician.

Treatment of rickets and osteomalacia caused by vitamin D3 deficiency lasts for one year.

Children are prescribed the medicinal product for rickets prevention starting from the second week of life until the end of the first year of life. During the second year of life, continued use of the product may be necessary, especially during winter months.

When doses exceeding 1000 IU of vitamin D3 daily are used, as well as during continuous or long-term treatment, serum creatinine levels and serum and urinary calcium levels should be regularly monitored. If necessary, the dose should be adjusted based on serum calcium concentration.

*In cases where high doses of cholecalciferol are required, it is recommended to use the medicinal product in another pharmaceutical form with a higher dosage strength.

Children. The product is indicated for children from the second week of life.

Overdose.

Vitamin D3 regulates calcium and phosphate metabolism. Overdose may lead to hypercalcemia, hypercalciuria, renal calcifications, bone damage, and cardiovascular changes. Hypercalcemia may occur after administration of 50,000–100,000 IU of vitamin D3 daily.

Symptoms of overdose may include: muscle weakness, loss of appetite, nausea, vomiting, constipation, polydipsia, polyuria, drowsiness, photophobia, pancreatitis, rhinorrhea, hyperthermia, decreased libido, conjunctivitis, hypercholesterolemia, elevated transaminase activity, arterial hypertension, cardiac arrhythmia, and uremia. Common symptoms include: muscle and joint pain, headache, and weight loss. Renal dysfunction may develop, characterized by albuminuria, erythrocyturia, polyuria, increased potassium loss, hypostenuria, nocturia, and moderate elevation of blood pressure.

In severe cases, corneal clouding may occur; less frequently, optic disc edema, uveitis, and even cataract development may be observed.

Kidney stones may form, and calcification may occur in soft tissues such as blood vessels, heart, lungs, and skin.

Cholestatic jaundice may rarely develop.

Treatment. Overdose requires treatment of hypercalcemia. Administration of the medicinal product must be discontinued. Depending on the degree of hypercalcemia, a low-calcium or calcium-free diet, high fluid intake, forced diuresis induced by furosemide, and administration of glucocorticoids and calcitonin are recommended.

In patients with normal renal function, calcium levels can be effectively reduced by intravenous infusion of sodium chloride solution (3–6 liters within 24 hours) with added furosemide. In some cases, 15 mg/kg body weight/hour of sodium edetate may also be administered, with continuous monitoring of calcium levels and ECG. In cases of oligoanuria, hemodialysis is required. There is no specific antidote.

Adverse Reactions.

Adverse reactions are usually not observed when the product is used at recommended doses.

In rare cases, hypersensitivity to the drug may occur, or, as a result of prolonged administration of very high doses, vitamin D intoxication (hypervitaminosis D) may develop.

Cardiovascular system: arrhythmia, arterial hypertension.

Gastrointestinal tract: loss of appetite, nausea, vomiting, constipation, dry mouth, flatulence, abdominal pain, diarrhea, dyspepsia, pancreatitis.

Nervous system: headache, drowsiness, mental disturbances, depression.

Urinary system: elevated calcium levels in blood and/or urine, nephrolithiasis and tissue calcification, uremia, polyuria.

Skin: hypersensitivity reactions, including urticaria, rash, pruritus.

Musculoskeletal system: myalgia, arthralgia, muscle weakness.

Eyes: conjunctivitis, photophobia.

Metabolism and nutrition: hypercholesterolemia, weight loss, polydipsia, increased sweating.

Hepatobiliary system: increased aminotransferase activity.

Psychiatric disorders: decreased libido.

There have also been reports of rhinorrhea, hyperthermia, and dry mouth.

Shelf life: 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

Capsules 12.5 mcg (500 IU) and 25 mcg (1000 IU)

10 capsules per blister pack; 6 blisters per carton.

Capsules 100 mcg (4000 IU)

10 capsules per blister pack; 3 blisters per carton.

Supply category: Over-the-counter (without prescription).

Manufacturer: JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of business activity:

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua