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Vitamin D3 (Tablets, Drops) Instructions for Use

ATC Code

A11CC05 (Colecalciferol)

Active Substance

Colecalciferol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Vitamins; vitamin A and D, including their combinations; vitamin D and its analogues

Pharmacological Action

Vitamin D3, an anti-rachitic agent. It participates in the regulation of calcium-phosphorus metabolism, enhances calcium absorption in the intestines and phosphate reabsorption in the kidneys, promotes bone mineralization, and is necessary for the normal functioning of the parathyroid glands. It is involved in the synthesis of lymphokines and ATP.

Deficiency of calcium and/or vitamin D3 causes hypersecretion of parathyroid hormone. As a result of this secondary hyperparathyroidism, bone tissue remodeling increases, leading to bone fragility and fractures. The use of calcium and vitamin D3 in the recommended dose range leads to a decrease in parathyroid hormone secretion.

Pharmacokinetics

After oral administration, Colecalciferol is absorbed from the small intestine. Cmax in tissues is reached in 4-5 hours, after which the concentration decreases somewhat, remaining at a constant level for a long time. Colecalciferol in blood plasma binds to the Colecalciferol-binding protein and is transported to the liver, where microsomal hydroxylation occurs to form the inactive metabolite 25-hydroxycholecalciferol (calcifediol). The concentration of circulating calcifediol in the blood is an indicator of the level of vitamin D3 in the body. Then calcifediol enters the kidneys, where it undergoes repeated hydroxylation to form the active metabolite 1,25-dihydroxycholecalciferol (calcitriol). Vitamin D3 and its metabolites can accumulate in muscle and adipose tissues, where their concentration can persist for several months. After taking high doses of vitamin D3, the concentration of calcifediol in the blood serum may remain elevated for several months. Hypercalcemia due to vitamin D3 overdose can persist for several weeks. Calcitriol undergoes further hydroxylation before being excreted from the body. The main route of excretion of vitamin D3, as well as its hydroxylated and sulfate derivatives, is bile (feces), and at least 2% of these substances are excreted in the urine. Colecalciferol crosses the placental barrier. It is excreted in breast milk.

Indications

Prevention of rickets and osteomalacia in children and adults; prevention of diseases associated with insufficiency (deficiency) of vitamin D3 in healthy children and adults without malabsorption; prevention of rickets in full-term and premature newborns; prevention of diseases associated with insufficiency (deficiency) of vitamin D3 in children and adults with malabsorption syndrome (chronic diseases of the small intestine, biliary cirrhosis of the liver, conditions after resection of the stomach and/or small intestine).

Treatment of rickets and osteomalacia in newborns, children and adults (against the background of mineral metabolism disorders in patients over 45 years of age, long-term immobilization due to injuries, adherence to diets with avoidance of milk and dairy products).

Maintenance therapy for osteoporosis in adults.

Treatment of hypoparathyroidism in adults.

ICD codes

ICD-10 code Indication
E20 Hypoparathyroidism
E20.1 Pseudohypoparathyroidism
E55 Vitamin D deficiency
E55.0 Active rickets
M83 Adult osteomalacia
M90 Osteopathies in diseases classified elsewhere
R29.0 Tetany
ICD-11 code Indication
1B12.40 Tuberculosis of bones or joints
5A50.1 Pseudohypoparathyroidism
5A50.Z Hypoparathyroidism, unspecified
5B57.0 Vitamin D-dependent rickets
5B57.Z Vitamin D deficiency, unspecified
FB81.4 Osteonecrosis due to haemoglobinopathy
FB81.Y Other specified osteonecrosis
FB83.2Z Adult osteomalacia, unspecified
FB85.1 Paget's disease of bone in neoplasms
FB8Y Other specified osteopathies or chondropathies
FB8Z Osteopathies or chondropathies, unspecified
MB47.D Tetany

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Determine the dosage individually based on the clinical indication, the patient’s age, and the specific formulation (tablets or drops).

For the prevention of vitamin D deficiency in healthy adults and children, administer a daily dose of 400-1000 IU.

For the treatment of established vitamin D deficiency or conditions like rickets and osteomalacia, use higher therapeutic doses as directed by a physician; a typical adult treatment dose is 1500-2000 IU daily.

For maintenance therapy in osteoporosis, a common dosage is 800-1000 IU per day, often co-administered with calcium supplements.

In patients with malabsorption syndromes (e.g., chronic small intestine disease, biliary cirrhosis), doses may need to be significantly higher than standard recommendations.

For pediatric populations, adjust the dose precisely according to age and body weight; use only formulations specifically designed for children.

Administer the daily dose with a meal to enhance absorption, particularly one containing fats.

During long-term treatment with doses exceeding 1000 IU per day, periodically monitor serum calcium levels to avoid hypercalcemia.

In patients concurrently taking thiazide diuretics, monitor calcium levels in blood and urine every 3-6 months due to an increased risk of hypercalcemia.

Reduce the prophylactic dose in children during periods of significant sun exposure to prevent cumulative overdose.

In immobilized patients and the elderly, use with caution and monitor calcium levels regularly, as they are at a higher risk for hypercalcemia and hypercalciuria.

Adverse Reactions

Symptoms caused by hypercalcemia and/or hypercalciuria are most likely with hypersensitivity to colecalciferol and overdose: anorexia, nausea, vomiting, headache, cardiac disorders, muscle and joint pain, weakness, irritability, depression, weight loss, severe thirst, polyuria, kidney stone formation, nephrocalcinosis, calcification of soft tissues.

Contraindications

Hypersensitivity to colecalciferol, hypervitaminosis D, hypercalcemia, hypercalciuria, urolithiasis with calcium stones, pseudohypoparathyroidism, acute and chronic diseases of the liver and kidneys; depending on the dosage form used – sarcoidosis, active form of pulmonary tuberculosis.

With caution

Patients who are immobilized; taking cardiac glycosides; taking additional amounts of vitamin D3 and calcium (e.g., as part of other drugs), with impaired excretion of calcium and phosphates in the urine, during treatment with benzothiadiazine derivatives and in immobilized patients (risk of developing hypercalcemia and hypercalciuria); in infants with a predisposition to early closure of fontanelles; with atherosclerosis, heart failure, organic heart lesions; with granulomatosis; hyperphosphatemia, phosphate nephrourolithiasis; with gastrointestinal diseases, peptic ulcer of the stomach and duodenum; with hypothyroidism.

Use in Pregnancy and Lactation

Should not be used in high doses during pregnancy.

When used in high doses in a nursing mother, symptoms of overdose may develop in the child.

During pregnancy and breastfeeding, the dose is determined individually by the doctor.

Use in Hepatic Impairment

Acute and chronic liver diseases.

Use in Renal Impairment

Acute and chronic kidney diseases.

Pediatric Use

In children and adolescents under 18 years of age, use in dosage forms intended for this category of patients.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

May be used in combination with calcium carbonate.

Use with caution in elderly patients, as well as in patients with long-term immobilization.

When used concomitantly with thiazide diuretics, the level of calcium in the blood and urine should be monitored every 3-6 months.

During long-term treatment with vitamin D3 in a daily dose exceeding 1000 IU, the level of calcium in the blood should be monitored.

Use in pediatrics

In children and adolescents under 18 years of age, use in dosage forms intended for this category of patients.

For children in conditions of increased insolation, the single and, accordingly, course dose should be reduced.

Drug Interactions

Phenytoin, primidone and drugs of the barbiturate group increase the need for vitamin D3 due to an increase in the rate of biotransformation of colecalciferol into inactive metabolites, due to a decrease in the level of calcifediol in blood plasma.

Concomitant therapy with corticosteroids may reduce the effectiveness of vitamin D3.

Concomitant therapy with cardiac glycosides (digitalis) may increase their toxic potential due to the development of hypercalcemia (risk of cardiac arrhythmia). In such patients, it is necessary to monitor ECG parameters and the level of calcium in blood plasma and urine, and adjust the doses of cardiac glycosides. It is also necessary to monitor the levels of digoxin and digitoxin in blood plasma if indicated.

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

Thiazide diuretics can reduce the excretion of calcium in the urine and, accordingly, increase the risk of developing hypercalcemia. In such patients, constant monitoring of the level of calcium in the blood and urine is necessary during long-term use of the drug.

Rifampicin and isoniazid may reduce the effectiveness of the drug due to an increase in the rate of biotransformation of vitamin D3.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Krka d.d., Novo mesto (Slovenia)

Dosage Form

Bottle OTC Icon Vitamin D3 Tablets 500 IU: 30, 60, 90, or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, slightly biconvex, with an engraving “1 D” on one side of the tablet.

1 tab.
Colecalciferol 500 IU* (0.0125 mg)

* which corresponds to 5 mg of colecalciferol concentrate

Excipients : sodium ascorbate, alpha-tocopherol, modified starch, sucrose, medium-chain triglycerides, colloidal anhydrous silicon dioxide, mannitol, sodium carboxymethyl starch (type A), corn starch, microcrystalline cellulose (type 102), talc, magnesium stearate.

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
10 pcs. – blisters (20) – cardboard packs.

Marketing Authorization Holder

Krka d.d., Novo mesto (Slovenia)

Dosage Form

Bottle OTC Icon Vitamin D3 Tablets 1000 IU: 30, 60, 90, or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, slightly biconvex, with an engraving “2 D” on one side of the tablet.

1 tab.
Colecalciferol 1000 IU* (0.025 mg)

* which corresponds to 10 mg of colecalciferol concentrate

Excipients : sodium ascorbate, alpha-tocopherol, modified starch, sucrose, medium-chain triglycerides, colloidal anhydrous silicon dioxide, mannitol, sodium carboxymethyl starch (type A), corn starch, microcrystalline cellulose (type 102), talc, magnesium stearate.

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
10 pcs. – blisters (20) – cardboard packs.

Marketing Authorization Holder

Vita Line, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Vitamin D3 Oral drops 15000 IU/ml.

Dosage Form, Packaging, and Composition

Oral drops

1 ml
Colecalciferol 15000 IU

15 ml – bottles – cardboard packs – Over-the-Counter

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Vitamin D3 Oil-based oral drops 20000 IU/ml: 10 ml, 15 ml, or 20 ml bottle

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent colorless or from slightly yellowish to light yellow viscous liquid with a characteristic odor.

1 ml
Colecalciferol (vit. D3) 20000 IU* (0.5 mg)

* 1 mg of colecalciferol corresponds to 40000 IU of vitamin D3 activity.

Excipients : medium-chain triglycerides – 939.5 mg.

10 ml – brown glass bottles (1) with dropper caps – cardboard packs.
15 ml – brown glass bottles (1) with dropper caps – cardboard packs.
20 ml – brown glass bottles (1) with dropper caps – cardboard packs.

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Vitamin D3 Oral drops 15000 IU/ml: 10 ml, 15 ml, or 20 ml bottle

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent or slightly opalescent colorless or slightly yellowish solution with a characteristic odor.

1 ml
Colecalciferol (vit. D3) 15000 IU* (0.375 mg)

*1 mg of colecalciferol corresponds to 40000 IU of vitamin D3 activity

Excipients : macrogol glyceryl ricinoleate – 75 mg, sucrose – 250 mg, disodium hydrogen phosphate dodecahydrate – 7 mg, citric acid monohydrate – 0.43 mg, benzyl alcohol – 15 mg, purified water – up to 1 ml.

10 ml – orange glass dropper bottles (1) – cardboard packs.
15 ml – orange glass dropper bottles (1) – cardboard packs.
20 ml – orange glass dropper bottles (1) – cardboard packs.
10 ml – brown glass bottles (1) with dropper caps – cardboard packs.
15 ml – brown glass bottles (1) with dropper caps – cardboard packs.
20 ml – brown glass bottles (1) with dropper caps – cardboard packs.

Marketing Authorization Holder

Erkapharm, JSC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Vitamin D3 Oral drops 15000 IU/ml: 10 ml bottle

Dosage Form, Packaging, and Composition

Oral drops colorless, transparent or slightly opalescent liquid with an anise odor.

1 ml
Colecalciferol 15000 IU

Excipients : macrogol glyceryl ricinoleate – 75 mg, sucrose – 250 mg, sodium hydrogen phosphate dodecahydrate – 7 mg, citric acid monohydrate – 0.43 mg, anise flavor – 16.2 mg, benzyl alcohol – 15 mg, purified water – up to 1 ml.

10 ml – bottles (1) – cardboard packs (with a measuring cup).

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Vitamin D3 Renewal Oral drops 15000 IU/1 ml: 10 ml, 15 ml, 20 ml, 25 ml or 30 ml bottle

Dosage Form, Packaging, and Composition

Oral drops

Colecalciferol 15000 IU/ml

10 ml – bottles – cardboard packs – Over-the-Counter
15 ml – bottles – cardboard packs – Over-the-Counter
20 ml – bottles – cardboard packs – Over-the-Counter
25 ml – bottles – cardboard packs – Over-the-Counter
30 ml – bottles – cardboard packs – Over-the-Counter
21.5 l – canisters – In-Bulk

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