Magnesium plus B6 (Tablets) Instructions for Use

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Manufactured By

Valenta Pharm, JSC (Russia)

ATC Code

A12CC30 (Combination of various magnesium salts)

Active Substances

Pyridoxine (Rec.INN WHO registered)

Magnesium lactate (BP British Pharmacopoeia)

Dosage Form

Magnesium plus B6

Film-coated tablets, 48 mg+5 mg: 50 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (5) – cartons.

Clinical-Pharmacological Group

Drug replenishing magnesium deficiency in the body

Pharmacotherapeutic Group

Magnesium preparation

Pharmacological Action

A combined preparation that replenishes magnesium deficiency.

Magnesium is a vital element found in all body tissues and is necessary for normal cell function, participating in many metabolic reactions. Magnesium ions reduce neuronal excitability, play an important physiological role in maintaining ionic balance in muscles (slow down neuromuscular transmission), and participate in many enzymatic reactions. Magnesium deficiency in the body can occur with dietary restrictions (diet) or with an increased need for magnesium (during increased physical and mental stress, stress, pregnancy, use of diuretics).

Pyridoxine (vitamin B6) is a coenzyme of amino acid and protein metabolism and participates in the regulation of nervous system metabolism. It is phosphorylated and, as pyridoxal phosphate, is part of enzymes that catalyze decarboxylation and transamination. It plays an important role in the metabolism of tryptophan, glutamic acid, cysteine, methionine, as well as in the transport of amino acids across the cell membrane. It is necessary for the activation of phosphorylase, for the formation of neurotransmitters, gamma-aminobutyric acid, glycine, serotonin. It participates in the metabolism of vitamin B12, folic acid, in the synthesis of porphyrins, and in the metabolism of unsaturated fatty acids. It improves the absorption of magnesium from the gastrointestinal tract and its penetration into cells.

Serum magnesium levels:

• From 12 to 17 mg/L (0.5-0.7 mmol/L) indicates moderate magnesium deficiency;
• Below 12 mg/L (0.5 mmol/L) indicates severe magnesium deficiency.

Pharmacokinetics

The absorption of magnesium in 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 one third is in smooth and striated muscle tissue. It is excreted primarily by the kidneys. The magnesium present in urine averages 1/3 of the administered dose.

Pyridoxine is easily absorbed by simple diffusion throughout the small intestine, with a larger amount absorbed in the jejunum. It penetrates well into all tissues. The highest concentrations of the vitamin are found in the liver and myocardium. Lower concentrations are found in muscles and the central nervous system. It is metabolized in the liver to form pharmacologically active metabolites (pyridoxal phosphate and pyridoxamine phosphate).

Pyridoxal phosphate is 90% bound to plasma proteins. It crosses the placenta and is secreted into breast milk. It is excreted by the kidneys. T_1/2 is 15-20 days.

Indications

Established magnesium deficiency, isolated or associated with other deficiency conditions, accompanied by symptoms such as:

• Increased irritability;
• Minor sleep disturbances;
• Gastrointestinal cramps or palpitations;
• Increased fatigue;
• Muscle pain and cramps;
• Tingling sensation.

ICD codes

Dosage Regimen

Consult a doctor before taking the drug.

Adults are recommended to take 6-8 tablets/day; children over 6 years of age (body weight over 20 kg) – 4-6 tablets/day.

The daily dose should be divided into 2-3 doses, taken with meals, with a glass of water.

The average duration of treatment is 1 month.

Treatment should be stopped immediately after normalization of blood magnesium levels.

Adverse Reactions

Allergic reactions.

From the digestive system: abdominal pain, constipation, nausea, vomiting, flatulence.

Development of hypermagnesemia is possible. Early signs and symptoms of hypermagnesemia: bradycardia, diplopia, sudden flushing of the skin of the face, headache, decreased blood pressure, nausea, shortness of breath, slurred speech, vomiting, weakness, in the presence of renal failure – dizziness.

Contraindications

• Severe renal failure (creatinine clearance less than 30 ml/min);
• Phenylketonuria;
• Lactase deficiency;
• Lactose intolerance;
• Glucose-galactose malabsorption;
• Hypermagnesemia;
• Children under 6 years of age;
• Hypersensitivity to the components of the drug.

With caution: in moderate renal insufficiency (risk of developing hypermagnesemia).

Use in Pregnancy and Lactation

Magnesium plus B6 can be used during pregnancy only as prescribed by a doctor.

It is not recommended to take the drug during lactation (magnesium and pyridoxine derivatives pass into breast milk).

Use in Renal Impairment

Contraindicated

• Severe renal failure (creatinine clearance less than 30 ml/min).

Pediatric Use

Contraindicated in children under 6 years of age. For children over 6 years of age (body weight over 20 kg) – 4-6 tablets/day.

Special Precautions

In case of concomitant calcium deficiency, magnesium deficiency should be corrected before starting additional calcium intake.

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.

Overdose

With normal renal function, oral intake of magnesium does not cause toxic reactions. Magnesium poisoning can develop in renal failure. Toxic effects mainly depend on the serum magnesium content.

Symptoms: decreased blood pressure, nausea, vomiting, slowed reflexes, ECG changes, respiratory depression, coma, cardiac arrest and cardiac paralysis, anuria.

Treatment: rehydration, forced diuresis. As an antidote for magnesium overdose (hypermagnesemia), calcium preparations (as an antagonist of magnesium) are used – calcium chloride or calcium gluconate. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.

Drug Interactions

It is preferable not to prescribe Magnesium plus B6 simultaneously with phosphate or sodium compounds, as this can significantly reduce the absorption of magnesium in the gastrointestinal tract.

Magnesium preparations reduce the absorption of tetracycline; when taken simultaneously, it is recommended to maintain a 3-hour interval before taking Magnesium plus B6.

Magnesium weakens the effect of oral anticoagulants (including coumarin and indandione derivatives) and reduces iron absorption.

Vitamin B6 reduces the pharmacological effects of levodopa.

Storage Conditions

Store the drug in a dry, light-protected place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

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.