Vitaprime^® B6 (Tablets) Instructions for Use

Marketing Authorization Holder

PharmVILAR NPO, LLC (Russia)

ATC Code

A11JB (Vitamins in combination with minerals)

Dosage Form

Vitaprime® B6

Film-coated tablets 48 mg+5 mg: 10, 20, 30, 40, 50, 60 or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex; darker or lighter inclusions are allowed.

Excipients: lactose monohydrate – 197.1 mg, hydroxypropylcellulose – 65 mg, macrogol 6000 – 60 mg, sodium starch glycolate – 20 mg, magnesium stearate – 7.1 mg, talc – 5.8 mg.

Shell composition hypromellose acetate succinate – 27.481 mg, talc – 8.244 mg, triethyl citrate – 8.244 mg, L-arginine – 0.756 mg, sodium lauryl sulfate – 0.275 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (12) – cardboard packs.
50 pcs. – dark glass jars (1) – cardboard packs.

Clinical-Pharmacological Group

Drug replenishing magnesium deficiency in the body

Pharmacotherapeutic Group

Magnesium preparation

Pharmacological Action

Magnesium is a vital element that is present in all body tissues and is necessary for normal cell function, participating in most metabolic reactions. In particular, it is involved in the regulation of nerve impulse transmission and muscle contraction.

The body receives magnesium from food. Magnesium deficiency in the body can occur with an improper diet, with an increased need for magnesium, or with an imbalance of intake, metabolism, and excretion of magnesium (for example, with increased physical and mental stress, stress, during pregnancy, when using diuretics).

Pyridoxine (vitamin B₆) participates in many metabolic processes, in the regulation of the nervous system metabolism. It improves the absorption of magnesium from the gastrointestinal tract and its penetration into cells.

A serum magnesium level from 12 to 17 mg/L (0.5-0.7 mmol/L) indicates a moderate magnesium deficiency; below 12 mg/L (0.5 mmol/L) indicates a severe magnesium deficiency.

Pharmacokinetics

The absorption of magnesium from the gastrointestinal tract is no more than 50% of the orally administered dose. In the body, magnesium is distributed mainly in the intracellular space – about 99%, of which approximately 2/3 is distributed in bone tissue, and 1/3 is in smooth and striated muscle tissue.

Magnesium is excreted primarily in the urine (at least 1/3 of the administered dose of magnesium).

Indications

Established magnesium deficiency, isolated or associated with other deficient conditions, accompanied by symptoms such as increased irritability, minor sleep disturbances, gastrointestinal spasms or palpitations, increased fatigue, muscle pain and cramps, tingling sensation.

ICD codes

Dosage Regimen

Administer orally with a full glass of water during a meal to improve tolerability and absorption.

Adhere strictly to the age-specific dosing schedule. For adults and children over 12 years, the typical daily dose is 3-4 tablets. For children aged 6 to 12 years, the typical daily dose is 2-3 tablets.

Divide the total daily dose into two or three separate administrations to maintain consistent magnesium levels and minimize gastrointestinal discomfort.

Initiate treatment only upon confirmation of magnesium deficiency or for symptom relief as directed by a physician. The duration of therapy is individualized.

Discontinue treatment immediately after normalization of serum magnesium concentration is confirmed by laboratory testing.

Do not exceed the recommended daily dose. Prolonged use of high-dose pyridoxine (exceeding 200 mg/day) carries a risk of developing sensory neuropathy.

For patients with severe deficiency or malabsorption syndromes, initiate therapy with intravenous magnesium preparations under medical supervision.

Maintain a minimum 3-hour interval between taking this drug and tetracycline antibiotics. Administer quinolone antibiotics at least 2 hours before or 6 hours after this preparation.

Adverse Reactions

Immune system disorders frequency unknown – allergic reactions, including skin reactions (urticaria, itching).

Gastrointestinal disorders frequency unknown – diarrhea, abdominal pain.

Contraindications

Severe renal failure (creatinine clearance <30 ml/min); children under 6 years of age; simultaneous use of levodopa; hypersensitivity to magnesium citrate and pyridoxine.

With caution

Moderate renal failure, because there is a risk of developing hypermagnesemia.

Use in Pregnancy and Lactation

During pregnancy, use is possible only if necessary and on the recommendation of a doctor.

Magnesium is excreted in breast milk. The use of this combination should be avoided during breastfeeding.

Use in Renal Impairment

The drug should be prescribed with caution in moderate renal failure, because there is a risk of developing hypermagnesemia.

The drug is contraindicated in severe renal failure (creatinine clearance less than 30 ml/min).

Pediatric Use

Contraindication: children under 6 years of age.

This combination can be used in children over 6 years of age in dosage forms intended for use in pediatrics according to age.

Special Precautions

In case of severe magnesium deficiency or malabsorption syndrome, treatment should be started with intravenous administration of magnesium preparations.

In case of concomitant calcium deficiency, it is recommended to eliminate the magnesium deficiency before starting calcium preparations or dietary supplements containing calcium.

With frequent use of laxatives, alcohol, intense physical and mental stress, the need for magnesium increases, which can lead to the development of magnesium deficiency in the body.

When using pyridoxine in high doses (more than 200 mg/day) for a long time (for several months or in some cases – years), sensory axonal neuropathy may develop, which is accompanied by symptoms such as numbness, impaired proprioceptive sensitivity, tremor of the distal limbs and gradually developing sensory ataxia (impaired coordination of movements). These disorders are usually reversible and disappear after discontinuation of vitamin B₆.

Drug Interactions

Pyridoxine inhibits the activity of levodopa (if a peripheral decarboxylase inhibitor of aromatic L-amino acids is not used simultaneously). Any amount of pyridoxine should be avoided in the absence of levodopa intake in combination with peripheral decarboxylase inhibitors of aromatic L-amino acids.

Simultaneous use of preparations containing phosphates, calcium salts or iron ions may impair the absorption of magnesium in the intestine.

When using antibiotics of the tetracycline group, an interval of at least 3 hours should be observed between oral administration of tetracycline and the magnesium citrate/pyridoxine combination, because magnesium preparations reduce the absorption of tetracyclines.

Quinolones should be administered at least 2 hours before or 6 hours after taking the magnesium citrate/pyridoxine combination to avoid impaired absorption of quinolones.

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.