Vitrum^® Osteomag (Tablets) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

A11AA03 (Multivitamins and other minerals, including their combinations)

Dosage Form

Vitrum® Osteomag

Film-coated tablets: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink in color, oval in shape, with beveled edges, engraved with “VITRUM” on one side and “OSTEOMAG” on the other; on the cross-section – a core from white to gray in color.

Excipients: microcrystalline cellulose – 20.7 mg, croscarmellose sodium – 80 mg, magnesium stearate – 20 mg.

Film coating composition: hypromellose – 19.345 mg, titanium dioxide – 10 mg, triacetin – 0.2 mg, Allura Red AC (E129) – 0.44 mg, Sunset Yellow (E110) – 0.1 mg, Indigo Carmine (E132) – 0.005 mg.

* – in the form of a colecalciferol concentrate; contains food fat, corn starch, gelatin, sucralose, alpha-tocopherol.

30 pcs. – polyethylene bottles (1) – cardboard packs.
60 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Calcium-phosphorus metabolism regulator

Pharmacological Action

A combined drug that regulates calcium metabolism.

The pharmacological action of the drug is determined by the properties of its constituent ingredients.

Colecalciferol (vitamin D₃) regulates the metabolism of calcium and phosphorus in the body, participates in the formation of the bone skeleton, helps maintain bone structure, enhances calcium absorption in the intestine and phosphorus reabsorption in the renal tubules.

Magnesium in combination with colecalciferol enhances calcium absorption. It participates in bone growth and mineralization, prevents the formation of calcium-oxalate stones.

Calcium participates in the formation of bone tissue, blood pressure control, and the blood clotting process. It promotes the formation of bones and teeth, increases bone density, and maintains healthy skin. It reduces the risk of developing osteoporosis. It contributes to the normal functioning of the nervous and muscular systems.

Zinc participates in bone formation.

Manganese participates in the process of energy production, metabolism of proteins and fats, building of bones and connective tissue, and osteosynthesis.

Copper influences the processes of bone mass formation, hemoglobin, and red blood cells. It participates in the formation of collagen, which is part of bone tissue and connective tissue, and helps prevent osteoporosis.

Boron participates in maintaining bone health, and the metabolic processes of calcium, phosphorus, and magnesium. It improves calcium absorption, reduces the risk of colecalciferol deficiency, and helps prevent postmenopausal osteoporosis.

Pharmacokinetics

The action of Vitrum^® Osteomag is the cumulative action of its components, therefore conducting kinetic observations is not possible; all components together cannot be traced using markers or bioassays.

Indications

Used as a therapeutic and prophylactic agent

• Replenishment of calcium and vitamin D₃ deficiency in old age, during or after menopause;
• Prevention of osteoporosis of various origins;
• Treatment of senile osteoporosis and osteomalacia;
• Complex therapy of osteoporosis and other metabolic osteopathies (in combination with special drugs).

ICD codes

Dosage Regimen

Take orally with a sufficient amount of water.

Administer one to two tablets daily for adults and children over 12 years of age.

Determine the exact daily dose based on the patient’s individual requirements for calcium, colecalciferol, and other minerals.

For prophylaxis of osteoporosis, one tablet per day is often sufficient.

For treatment of established deficiencies or metabolic osteopathies, administer two tablets daily.

Do not exceed the maximum daily dose of two tablets.

Take into account that two tablets provide the full daily requirement for vitamin D₃, calcium, and magnesium.

Administer the tablet whole; do not chew or crush.

Take the drug two hours before or after consuming other medications, particularly tetracycline antibiotics, salicylates, sulfonamides, beta-blockers, and indirect anticoagulants, to prevent impaired absorption.

For long-term therapy, monitor renal function and urinary calcium excretion.

Discontinue use and consult a physician if signs of hypercalcemia or hypercalciuria appear.

Adverse Reactions

From the digestive system: constipation, diarrhea, flatulence, epigastric pain, nausea.

Other: increased calcium content in urine and blood with prolonged use of the drug in high doses.

Contraindications

• Severe renal impairment;
• Elevated blood calcium levels (hypercalcemia);
• Increased urinary calcium excretion (hypercalciuria);
• Urolithiasis (formation of calcium stones);
• Children under 12 years of age;
• Hypersensitivity to vitamin D₃ and other components of the drug.

Use in Pregnancy and Lactation

The drug Vitrum^® Osteomag is used during pregnancy and lactation according to indications.

Throughout the entire period of pregnancy and lactation, constant medical supervision is necessary.

Special Precautions

Use with caution in patients with sarcoidosis or renal insufficiency.

Do not exceed the recommended doses.

When using the drug, it should be taken into account that 2 tablets of Vitrum^® Osteomag satisfy the daily requirement for vitamin D₃, calcium, and magnesium.

Control of laboratory parameters

When used in high doses, monitoring of renal function is necessary. In case of long-term treatment, the amount of calcium excreted in the urine should be checked.

Overdose

Data on overdose of Vitrum^® Osteomag are not provided.

Drug Interactions

The drug slows down the absorption of antibiotics of the tetracycline group, acetylsalicylic acid and other salicylates, sulfonamides, beta-blockers and indirect anticoagulants. In this regard, the drug is recommended to be taken 2 hours before or 2 hours after taking other medications.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature from 10°C (50°F) to 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.