Magnistad^® (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

STADA-VN Joint Venture Company Limited (Vietnam)

ATC Code

A12CC (Magnesium preparations)

Active Substances

Pyridoxine (Rec.INN registered by WHO)

Magnesium lactate (BP British Pharmacopoeia)

Dosage Form

Magnistad®

Tablets, enteric-coated, 470 mg+5 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Tablets, enteric-coated white, oval, biconvex.

Excipients: wheat starch 40 mg, lactose monohydrate 60 mg, microcrystalline cellulose 25 mg, povidone K90 15 mg, croscarmellose sodium 20 mg, stearic acid 15 mg, magnesium stearate 15 mg.

Enteric coating composition methacrylic acid and methyl methacrylate copolymer [1:1] (eudragit L 100) 22.5 mg, triethyl acetate 4.5 mg, talc 7.5 mg, titanium dioxide 4.583 mg.

10 pcs. – blister packs (aluminum/PVC) (5) – cardboard packs.

Clinical-Pharmacological Group

Drug replenishing magnesium deficiency in the body

Pharmacotherapeutic Group

Magnesium preparation

Pharmacological Action

A combined preparation; contains therapeutic doses of magnesium lactate and pyridoxine hydrochloride, which improves the absorption of magnesium in the intestine, its transport from the blood and interstitial fluid into the cells.

Magnesium is a vital element that ensures the entry of glycolysis products into the Krebs cycle, participates in the synthesis and breakdown of nucleic acids, synthesis of proteins, fatty acids and lipids, in particular phospholipids, also participates in the synthesis of enzymes that provide energy reactions (glycolysis, hydrolytic breakdown of ATP). Magnesium is necessary for neuromuscular transmission, bone mineralization, and the realization of the effect of parathyroid hormone. Magnesium ions are physiological antagonists of calcium ions. Magnesium forms sites in the structure of a number of receptors (NMDA-, AMPA-receptors to acetylcholine, norepinephrine and dopamine), it is necessary for the normal metabolism of neurotransmitters (catecholamines, tyrosine, dopamine, norepinephrine, serotonin, γ-aminobutyric acid). Magnesium, by activating tyrosine kinase, helps reduce tissue insulin resistance and induce insulin-dependent glucose uptake. Pyridoxine hydrochloride (vitamin B6) as a coenzyme participates in metabolic processes, is necessary for the normal functioning of the central and peripheral nervous system. Upon entering the body, it is phosphorylated, converted to pyridoxal-5-phosphate, and is part of enzymes that carry out the decarboxylation and transamination of amino acids. It participates in the metabolism of tryptophan, methionine, cysteine, glutamic and other amino acids, lipid and carbohydrate metabolism. Pyridoxine is necessary for the synthesis of γ-aminobutyric acid and heme.

Pharmacokinetics

The absorption of magnesium lactate in the gastrointestinal tract is slow, not more than 50% of the orally administered dose. About 25-30% of the absorbed magnesium circulates in a protein-bound state. The absorbed magnesium is excreted by the kidneys, the unabsorbed part is excreted through the intestines. Magnesium crosses the placental barrier; it penetrates into breast milk in small amounts.

Pyridoxine hydrochloride is well absorbed in the gastrointestinal tract, then metabolized in the liver to form pharmacologically active metabolites (pyridoxal phosphate and pyridoxamine phosphate). The normal concentration of pyridoxine in plasma is 30-80 ng/ml. The highest amount of pyridoxine is found in the liver, then in the muscles and brain tissue. The total content of pyridoxine in the body is 167 mg. Pyridoxal phosphate is 90% bound to plasma proteins. The half-life is 15-20 days. It is excreted by the kidneys. Pyridoxal phosphate crosses the placenta. It is removed by hemodialysis.

Indications

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

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

ICD codes

Dosage Regimen

Orally, with meals, with a glass of water.

Adults are recommended to take 6-8 tablets per day.

Children over 6 years of age (body weight over 20 kg) are recommended to take 4 – 6 tablets per day.

The daily dose should be divided into 2 – 3 doses. The average course of treatment is 1 month.

Immediately after normalization of the magnesium level in the blood, the drug should be discontinued.

Adverse Reactions

Allergic reactions, abdominal pain, diarrhea, nausea, vomiting, flatulence.

Contraindications

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

With caution in moderate renal insufficiency, since there is a risk of developing hypermagnesemia.

Use in Pregnancy and Lactation

Magnistad^® can be used during pregnancy only on the recommendation of a doctor. Magnesium penetrates into breast milk.

The use of the drug during lactation should be avoided. If it is necessary to take the drug, breastfeeding should be discontinued.

Use in Renal Impairment

The drug should be used with caution in moderate renal insufficiency, since there is a risk of developing hypermagnesemia.

Contraindicated in severe renal failure (creatinine clearance less than 30 ml/min).

Pediatric Use

Contraindicated in children under 6 years of age.

Children over 6 years of age (body weight over 20 kg) are recommended to take 4 – 6 tablets per day. The daily dose should be divided into 2 – 3 doses. The average course of treatment is 1 month.

Special Precautions

Magnistad^® should not be taken on an empty stomach, as diarrhea may develop.

When used concomitantly with tetracyclines, it is necessary to observe a 3-hour interval between taking Magnistad^® and the tetracycline drug. When used concomitantly with drugs containing phosphates or calcium salts, an interval of 1 hour must be observed.

Effect on ability to drive vehicles and machinery

No effect.

Overdose

With normal renal function, oral intake of magnesium does not cause toxic reactions. However, magnesium overdose can develop in renal failure.

Symptoms asystole, bradycardia, central nervous system depression, coma, hypotension (fainting), muscle paralysis, polyuria or oliguria, diplopia and blurred vision, difficulty breathing.

Treatment discontinue the drug; specific – if the blood magnesium level exceeds 10 mmol/l, 10 ml of a 10% calcium gluconate solution should be administered, but no more than 2 times.

Non-specific – rehydration measures, forced diuresis.

In case of renal failure, hemodialysis or peritoneal dialysis is necessary.

Drug Interactions

Simultaneous use of drugs containing phosphates or calcium salts can significantly reduce the absorption of magnesium in the gastrointestinal tract. Magnesium preparations reduce the absorption of tetracycline.

Magnesium weakens the effect of oral thrombolytic agents and reduces the absorption of iron. Pyridoxine reduces the effectiveness of levodopa.

Storage Conditions

Store 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 – 3 years.

Dispensing Status

The drug is dispensed without a 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.