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Dosage form: & nbspenteric coated tablets
Composition:

1 tablet, coated with enteric coating, contains:

active substances: magnesium lactate dihydrate - 470.0 mg (corresponding to 48.0 mg of magnesium), pyridoxine hydrochloride (vitamin B6) - 5.0 mg;

Excipients: wheat starch 40.0 mg, lactose monohydrate 60.0 mg, microcrystalline cellulose 25.0 mg, povidone-K90 15.0 mg, croscarmellose sodium 20.0 mg, stearic acid 15.0 mg, magnesium stearate 15.0 mg ;

shell: methacrylic acid and methyl methacrylate copolymer [1: 1] (eudragit L 100) - 22,500 mg, triethyl citrate 4,500 mg, talc 7,500 mg, titanium dioxide 4,583 mg.

Description:

Tablets are oval, biconvex, covered with an enteric-insoluble coat of white color.

Pharmacotherapeutic group:magnesium preparation
ATX: & nbsp
  • Combination of various magnesium salts
  • Pharmacodynamics:

    Combined drug; contains therapeutic doses of magnesium lactate and pyridoxine hydrochloride, improving 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 supply of glycolysis products to the Krebs cycle, is involved in the synthesis and decomposition of nucleic acids, the synthesis of proteins, fatty acids and lipids, in particular phospholipids, also participates in the synthesis of enzymes that provide energy responses (glycolysis, hydrolytic cleavage of ATP ).Magnesium is necessary for the implementation of neuromuscular transmission, the mineralization of bones, the realization of the effect of parathyroid hormone. Magnesium ions are a physiological antagonist of calcium ions. Magnesium forms patches in the structure of a number of receptors (NMDA-, AMPA receptors for acetylcholine, noradrenaline and dopamine), it is necessary for the normal exchange of neurotransmitters (catecholamines, tyrosine, dopamine, norepinephrine, serotonin, y-aminobutyric acid). Magnesium, through the activation of tyrosine kinase, helps to reduce insulin resistance of tissues and induce insulin-dependent glucose uptake.

    Pyridoxine hydrochloride (vitamin B6) as coenzyme involved in metabolic processes, is necessary for the normal functioning of the central and peripheral nervous system. Entering the body, it is phosphorylated, converted to pyridoxal-5-phosphate, is part of the enzymes that carry out decarboxylation and transamination of amino acids. Participates in the exchange 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:

    Absorption of magnesium lactate in the gastrointestinal tract is slow, not more than 50% of the dose taken internally. About 25-30% of the absorbed magnesium circulates in the protein-bound state. The absorbed magnesium is excreted by the kidneys, the non-absorbed part is excreted through the intestine. Magnesium overcomes the placental barrier; in a small amount penetrates into breast milk.

    Pyridoxine hydrochloride well absorbed in the gastrointestinal tract, then metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxalphosphate and pyridoxamino phosphate). The concentration of pyridoxine in plasma is normally 30-80 ng / ml. Most of the pyridoxine is contained in the liver, then in the muscles and brain tissue. The total content of pyridoxine in the body is 167 mg. Pyridoxalphosphate with plasma proteins binds to 90%. The half-life is 15-20 days. It is excreted by the kidneys.

    Pyridoxal phosphate penetrates the placenta.

    It is in hemodialysis.

    Indications:

    The established deficiency of magnesium, isolated or associated with other deficient conditions, accompanied by such symptoms as: increased irritability, minor sleep disorders, gastrointestinal spasms, palpitations, increased fatigue, pain and muscle spasms, tingling sensations.

    Contraindications:

    Hypersensitivity to the components of the drug, marked renal failure (creatinine clearance less than 30 ml / min), phenylketonuria, children under 6 years of age; deficiency of lactase, lactose intolerance, glucose-galactose malabsorption (the preparation contains lactose).

    Carefully:

    With moderate failure of kidney function, since there is a risk of hypermagnesemia.

    Pregnancy and lactation:

    Magnistad ® can be used during pregnancy only on the recommendation of a doctor.

    Magnesium penetrates into breast milk. Avoid the use of the drug during lactation. If necessary, breast-feeding should be discontinued.

    Dosing and Administration:

    Inside, with food, drinking a glass of water.

    Adults it is recommended to take 6-8 tablets per day.

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

    The daily dose should be divided into 2-3 divided doses.

    The average course of treatment is 1 month.

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

    Side effects:

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

    Overdose:

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

    Symptoms: asystole, bradycardia, central nervous system inhibition, coma, hypotension (syncope), muscle paralysis, polyuria or oliguria, diplopia and blurred vision, shortness of breath.

    Treatment: stop taking the drug; specific - if the level of magnesium in the blood exceeds 10 mmol / l, 10 ml of a 10% calcium gluconate solution should be administered, but not more than 2 times.

    Nonspecific - rehydration measures, forced diuresis.

    With renal failure, hemodialysis or peritoneal dialysis is necessary.

    Interaction:

    The 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, reduces the absorption of iron.

    Pyridoxine reduces the effectiveness of levodopa.

    Special instructions:

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

    When combined with tetracyclines, it is necessary to observe an interval of 3 hours between the methods of Magnistad® and a preparation of the tetracycline series.

    When combined with preparations containing phosphates or calcium salts, the interval of 1 h should be observed.

    Effect on the ability to drive transp. cf. and fur:

    Does not affect.

    Form release / dosage:Tablets, covered with enteric coating.
    Packaging:

    For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil.

    Five contour mesh packages together with instructions for medical use of the drug in a pack of cardboard.

    Storage conditions:

    Store in a dry, dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001309
    Date of registration:01.12.2011 / 08.02.2013
    Date of cancellation:2016-12-01
    The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC
    Manufacturer: & nbsp
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp14.03.2016
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