Vitamin D3 BON (Solution) Instructions for Use

Marketing Authorization Holder

Laboratoires Bouchara-Recordati (France)

ATC Code

A11CC05 (Colecalciferol)

Active Substance

Colecalciferol (Rec.INN registered by WHO)

Dosage Form

Vitamin D3 BON

Solution for intramuscular injection and oral administration 200 thousand IU/1 ml: amp. 1 pc.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection and oral administration transparent, with a yellowish tint, odorless.

Excipients: medium-chain triglycerides.

1 ml – ampoules (1) – plastic cases (1) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Vitamin – calcium-phosphorus metabolism regulator

Pharmacological Action

A drug that regulates calcium and phosphorus metabolism. It enhances calcium absorption in the intestines and phosphorus reabsorption in the renal tubules.

It promotes the formation of the bone skeleton and teeth in children and the preservation of bone structure.

Vitamin D₃ is necessary for the normal functioning of the parathyroid glands and is also involved in the functioning of the immune system, affecting the production of lymphokines.

It participates in the ATP synthesis process.

Pharmacokinetics

Absorption

After oral administration, it is absorbed in the distal part of the small intestine with the participation of bile acids.

Distribution

It binds to alpha₂-globulins and partially to albumin.

The main storage sites are adipose tissue and muscles.

Metabolism

It is transformed in the liver (first hydroxylation) into 25-hydroxycholecalciferol (calcifediol). This is the main circulating form, which in the kidneys (second hydroxylation) is converted into corresponding active forms. The most significant of these is 1,25-dihydroxycholecalciferol (calcitriol).

Excretion

It is excreted mainly with feces, a small amount – with urine.

Indications

Prevention and treatment

• Rickets;
• Spasmophilia;
• Osteomalacia of various origins;
• Metabolic osteopathies (hypoparathyroidism and pseudohypoparathyroidism);
• Hypocalcemic tetany.

ICD codes

Dosage Regimen

The drug is used both intramuscularly and orally.

For infants receiving milk with vitamin D, 100,000 IU (i.e., 1/2 amp.) is prescribed every 6 months.

For breastfed infants or those not receiving milk with vitamin D, children over 5 years of age the drug is prescribed at a dose of 200,000 IU (1 amp.) every 6 months.

For adolescents it is prescribed at a dose of 200,000 IU (1 amp.) every 6 months during the winter.

For pregnant women 100,000 IU (1/2 amp.) is prescribed from the 6th to the 7th month of pregnancy; repeated administration of the same dose is possible in case of lack of sun if the last trimester of pregnancy falls in the winter period.

For elderly patients 100,000 IU (1/2 amp.) is prescribed every 3 months.

For adults or children with nutritional disorders the drug is prescribed at a dose from 100,000 IU to 200,000 IU (1/2 – 1 amp.) every 3 months.

For adults or children with concomitant antiepileptic therapy the drug is prescribed at the same dose from 100,000 IU to 200,000 IU (from 1/2 to 1 amp.) every 3 months.

For vitamin D₃ deficiency 200,000 IU (1 amp.) is prescribed; a single repeated administration within the next 1-6 months is recommended.

To accurately measure the required volume of the drug, a glass syringe should be used.

Adverse Reactions

From electrolyte metabolism: hyperphosphatemia, hypercalcemia, hypercalciuria.

From the digestive system: anorexia, constipation.

From the urinary system: polyuria, renal failure.

From the CNS: headache.

From the musculoskeletal system: myalgia, arthralgia.

From the cardiovascular system: increased BP, arrhythmias.

Other: allergic reactions.

Contraindications

• Hypercalcemia;
• Hypercalciuria;
• Sarcoidosis;
• Calcium nephrourolithiasis;
• Thyrotoxicosis (possibility of hypersensitivity);
• Renal osteodystrophy with hyperphosphatemia;
• Hypervitaminosis D;
• Hypersensitivity to vitamin D₃.

With caution the drug should be prescribed for atherosclerosis, heart failure, renal failure, pulmonary tuberculosis (active form), hyperphosphatemia, phosphate nephrourolithiasis, organic heart lesions, acute and chronic diseases of the liver and kidneys, gastrointestinal diseases (including gastric and duodenal ulcers), during pregnancy and lactation, and for hypothyroidism.

Use in Pregnancy and Lactation

Hypercalcemia during pregnancy can cause physical and mental development defects in the fetus.

Vitamin D₃ and its metabolites pass into breast milk.

During pregnancy and lactation, the daily dose of cholecalciferol should not exceed 600 IU.

Use in Hepatic Impairment

The drug should be prescribed with caution in acute and chronic liver diseases.

Use in Renal Impairment

The drug should be prescribed with caution in renal failure, phosphate nephrourolithiasis, and acute and chronic kidney diseases.

Pediatric Use

See the “Dosage Regimen” section.

Geriatric Use

See the “Dosage Regimen” section.

Special Precautions

When using doses above 1000 IU/day, as well as with continuous use of the drug for several months, periodic determination of calcium and phosphorus concentrations in the blood serum is recommended to exclude chronic hypervitaminosis D₃ and hyperphosphatemia.

To prevent the development of hyperphosphatemia in patients with bone lesions of renal origin, the drug can be prescribed together with phosphate-binding agents.

Overdose

Symptoms of hypervitaminosis D: early (due to hypercalcemia) – constipation or diarrhea, dryness of the oral mucosa, headache, pollakiuria, nocturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, unusual fatigue, general weakness, hypercalcemia, hypercalciuria; late – bone pain, cloudy urine (appearance of hyaline casts, proteinuria, leukocyturia in the urine), increased BP, skin itching, eye photosensitivity, conjunctival hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia, weight loss, rarely – psychosis (changes in psyche and mood).

Symptoms of chronic vitamin D overdose (when taken for several weeks or months for adults in doses of 20-60 thousand IU/day, for children – 2-4 thousand IU/day): calcification of soft tissues, kidneys, lungs, blood vessels, arterial hypertension, renal and chronic heart failure (these effects most often occur when hypercalcemia is accompanied by hyperphosphatemia), growth impairment in children (long-term use at a dose of 1.8 IU/day).

Treatment: drug withdrawal, diet low in calcium, consumption of large amounts of fluid, prescription of corticosteroids, α-tocopherol, ascorbic acid, retinol, thiamine; in severe cases – intravenous administration of large amounts of 0.9% sodium chloride solution, furosemide, electrolytes, hemodialysis. There is no specific antidote. To exclude overdose, in some cases, determination of blood calcium concentration is recommended.

Drug Interactions

When Vitamin D3 BON is taken simultaneously with thiazide diuretics, the risk of hypercalcemia increases.

When used simultaneously with phenytoin (increased rate of biotransformation), cholestyramine, corticosteroids, calcitonin, derivatives of etidronic and pamidronic acids, plicamycin, gallium nitrate, the effectiveness of the drug Vitamin D3 BON is reduced.

Retinol, when used simultaneously with Vitamin D3 BON, reduces the toxicity of the latter.

Barbiturates, when used simultaneously with Vitamin D3 BON, increase the rate of biotransformation of cholecalciferol.

Vitamin D3 BON, when used simultaneously, increases the toxicity of cardiac glycosides.

Long-term therapy with the drug Vitamin D3 BON against the background of simultaneous use of antacids containing aluminum and magnesium increases their concentration in the blood and the risk of intoxication (especially in the presence of chronic renal failure).

Cholestyramine, colestipol, and mineral oils reduce the absorption of cholecalciferol in the gastrointestinal tract, which requires an increase in its dose when used simultaneously with the above drugs.

Colecalciferol increases the absorption of phosphorus-containing drugs and the risk of hyperphosphatemia.

When the drug Vitamin D3 BON is used simultaneously with sodium fluoride, the interval between doses should be at least 2 hours; with oral forms of tetracyclines – at least 3 hours.

Simultaneous use with other analogues of vitamin D₃ increases the risk of hypervitaminosis.

Storage Conditions

The drug should be stored in a light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 4 years.

Dispensing Status

The drug is dispensed by prescription.

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.