Active substanceMagnesium sulfateMagnesium sulfate
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  • Dosage form: & nbspsolution for intravenous administration
    Composition:

    In 10 ml of the solution contains:

    Active substance:

    Magnesium sulfate heptahydrate 4.095 g, which corresponds to magnesium sulfate 2.0 g.

    Excipients: sulfuric acid 96% (for pH adjustment) 0.368 mg, water for injection up to 10 ml.

    Description:

    A clear, colorless solution.

    Pharmacotherapeutic group:Vasodilator
    ATX: & nbsp

    A.12.C.C   Preparations of magnesium

    Pharmacodynamics:

    When parenteral administration has a sedative, diuretic, arteriodilating, anticonvulsant, antiarrhythmic, hypotensive, spasmolytic, in large doses - curare-like (depressing effect on neuromuscular transmission), tocolytic, hypnotic and narcotic effect, suppresses the respiratory center.Magnesium is a physiological calcium antagonist and is able to displace it from binding sites. Regulates metabolic processes, interneuronal transmission and muscle excitability, prevents calcium intake through the presynaptic membrane, reduces the amount of acetylcholine in the peripheral nervous system and central nervous system (CNS). Relaxes smooth muscles, lowers blood pressure (BP) (mostly increased), increases diuresis.

    Anticonvulsant action - magnesium reduces the release of acetylcholine from neuromuscular synapses, suppressing neuromuscular transmission, has a direct inhibitory effect on the central nervous system.

    Antiarrhythmic action - magnesium reduces the excitability of myocytes, restores ion balance, stabilizes cell membranes, breaks sodium current, slow incoming calcium current and unilateral potassium current. The cardioprotective effect is due to the expansion of the coronary arteries, the reduction of the total peripheral vascular resistance and platelet aggregation. Tocolytic action - magnesium inhibits the contractility of the myometrium (reduced absorption, binding and distribution of calcium in smooth muscle cells),strengthens the blood flow in the uterus as a result of the expansion of its vessels. It is an antidote for poisoning with salts of heavy metals. Systemic effects develop almost instantly after intravenous (IV) administration. Duration of action with / in the introduction - 30 minutes.

    Pharmacokinetics:

    The equilibrium concentration (Css) - 2 - 3.5 mmol / l. Penetrates through the blood-brain and placental barriers, creates in the mother's milk concentrations of 2 times the concentration in the plasma.

    Excretion by the kidneys, the rate of renal excretion is proportional to the concentration in the plasma and the level of glomerular filtration.

    Indications:

    Arterial hypertension (including hypertensive crisis with brain edema phenomena), polymorphic ventricular tachycardia (such as pirouette), convulsive syndrome (to suppress convulsions with eclampsia, to prevent seizures in severe pre-eclampsia, to relieve severe uterine contractions), poisoning salts of heavy metals (mercury, arsenic, tetraethyl lead), hypomagnesemia (including increased demand for magnesium and acute hypomagnesemia - tetany).

    Contraindications:

    Hypersensitivity to the drug; atrioventricular blockade of I-III degree (AV blockade); severe renal failure (if creatinine clearance is less than 20 ml / min); severe arterial hypotension; conditions associated with calcium deficiency and respiratory center depression; bradycardia; prenatal period (2 hours before delivery).

    Carefully:Myasthenia gravis, chronic renal failure (if creatinine clearance is more than 20 ml / min), respiratory diseases, acute inflammatory diseases of the gastrointestinal tract, old age, pregnancy, lactation period, children's age.
    Pregnancy and lactation:Take with caution during pregnancy and lactation.
    Dosing and Administration:

    Intravenously, slowly.

    Doses are refined taking into account the therapeutic effect and the concentration of magnesium ions in the blood serum. Preeclampsia and eclampsia. The dose is set individually depending on the clinical situation. The dose of saturation is 2-4 g in 5-20 minutes (infusion). The maintenance dose is 1 - 2 g per hour.

    Theta of the uterus. The dose of saturation is 4 g after 20 min (infusion). The maintenance dose is first -1-2 g per hour, later - 1 g per hour (it can be administered drip 24-72 hours).

    Hypomagnesemia.

    In newborns. The daily dose is 0.2-0.8 mg / kg IV slowly.

    In adults.

    Easy. Kormagnezin® is used parenterally if it is impossible or inappropriate to use the oral route of magnesium preparations (due to nausea, vomiting, impaired resorption in the stomach, etc.).

    Heavy. The initial dose is 5 g. The dose is poured into 1 liter of infusion solution and slowly injected / in.

    Dosed depending on the concentration of the drug in the blood serum.

    Prevention of hypomagnesemia in patients receiving only parenteral nutrition. If there are no magnesium in the nutrient solutions, it is added additionally. The daily dose is -1.5-4 g. Usually 1 g of magnesium sulfate is added to 1 liter of parenteral nutrition solution. The maximum daily intake of magnesium sulfate for adults is 40 g. For hypertensive crises, enter 5.2 mg of Cormagnezin ® solution.

    For arresting arrhythmias, 1-2 g for about 5 minutes, possibly repeated administration, are intravenously administered.

    Doses of Kormagnezin® are indicated in grams.

    They correspond to the amount of solution: 1 g - 5 ml (200 mg / ml); 2 g - 10 ml (200 mg / ml); 3 g - 15 ml (200 mg / ml); 4 g - 20 ml (200 mg / ml); 5 g - 25 ml (200 mg / ml); 10 g - 50 ml (200 mg / ml); 15 g - 75 ml (200 mg / ml); 20 g 100 ml (200 mg / ml); 30 g - 150 ml (200 mg / ml); 40 g - 200 ml (200 mg / ml).

    A solution of Kormagnezin® in ampoules is diluted with injection solutions: 0.9% sodium chloride or 5% dextrose (glucose).

    Side effects:

    Slowing down the frequency of breathing; dyspnea; acute circulatory failure; weakening of reflexes; hyperemia; arterial hypotension; hypothermia; weakening of muscle tone; atony of the uterus; hyperhidrosis; anxiety; marked sedation; polyuria; reduction of heart rate; changes in the electrocardiogram. The drug lowers the excitability of the respiratory center, large doses of the drug with parenteral administration can cause paralysis of the respiratory center.

    Early signs and symptoms of hypermagnesemia: bradycardia, diplopia, sudden rush of blood to the face, headache, decreased blood pressure, nausea, shortness of breath, blurred speech, vomiting, general weakness.

    Symptoms of hypermagnesia, ranked in order of increasing the concentration of magnesium ions in the blood serum: a decrease in deep tendon reflexes (2-3.5 mmol / l), prolongation of the PQ interval and expansion of the QRS complex on an electrocardiogram (2.5-5 mmol / l) tendon reflexes (4-5 mmol / l), respiratory center depression (5-6.5 mmol / l), cardiac conduction disorder (7.5 mmol / l), cardiac arrest (12.5 mmol / l).

    Overdose:Symptoms: disappearance of the knee reflex, nausea, vomiting, a sharp decrease in blood pressure, bradycardia, respiratory depression and central nervous system.

    Treatment: I / slowly enter a solution of calcium chloride or calcium gluconate - 5-10 ml 10%, oxygen therapy, inhalation of carbogen, artificial respiration, peritoneal dialysis or hemodialysis, symptomatic therapy.

    Interaction:

    Patients who, together with magnesium sulfate, use other medicines should inform the doctor about this.

    Strengthens the effect of other drugs that depress the central nervous system. Cardiac glycosides increase the risk of conduction disruption and atrioventricular blockade (especially with simultaneous intravenous administration of calcium salts). Muscle relaxants and nifedipine strengthen the neuromuscular blockade. With the joint use of magnesium sulfate for parenteral administration with other vasodilators, an increase in the hypotensive effect is possible. Barbiturates, narcotic analgesics increase the likelihood of oppression of the respiratory center.

    It interferes with the absorption of antibiotics of the tetracycline group, weakens the action of streptomycin and tobramycin.

    Calcium salts reduce the effect of magnesium sulfate.

    Pharmaceutically incompatible (forms a precipitate) with calcium preparations, carbonates, bicarbonates and phosphates of alkali metals, clindamycin phosphate,hydrocortisone sodium succinate, polymyxin In sulfate, procaine hydrochloride, salicylates and tartrates.

    At concentrations of magnesium ions above 10 mmol / ml in mixtures for total parenteral nutrition, fat emulsion separation is possible.

    Special instructions:

    Kormagnezin should be used carefully so that the toxic concentration of the drug does not appear. Elderly people should usually take a reduced dose, because they have decreased kidney function. Patients with impaired renal function (if creatinine clearance is more than 20 ml / min) and oliguria should not receive more than 20 g of magnesium sulfate (81 mmol Mg2+) for 48 hours, do not enter magnesium sulfate I / O too fast. It is recommended to control the concentration of magnesium ions in the blood serum (should not be higher than 0.8 - 1.2 mmol / l), diuresis (not less than 100 ml / h), respiratory rate (at least 16 / min), blood pressure.

    With the administration of Kormagnezin it is necessary to have a calcium solution prepared for intravenous administration, for example, a 10% solution of calcium gluconate. If necessary, simultaneous in / in the introduction of magnesium and calcium, they are injected into different veins. When magnesium sulfate is used, the results of radiological studies for which technetium is applied may be distorted.
    Effect on the ability to drive transp. cf. and fur:Clinical studies to assess the effect on the ability to drive vehicles, mechanisms have not been carried out.
    Form release / dosage:Solution for intravenous administration 200 mg / ml.
    Packaging:

    For 10 ml in an ampoule of transparent hydrolytic glass type I, a white dot is applied to the ampoule with paint.

    5 ampoules in a cardboard pallet with separators or in a pallet made of PVC are placed in a cardboard box together with instructions for use.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:5 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N012743 / 01
    Date of registration:25.03.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Wörwag Pharma GmbH & Co. KG. KGWörwag Pharma GmbH & Co. KG. KG Germany
    Manufacturer: & nbsp
    Representation: & nbspVEVWAG PHARMA GmbH & Co. KG VEVWAG PHARMA GmbH & Co. KG Germany
    Information update date: & nbsp04.02.2018
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