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

    Per 1 ml:

    Active substance:

    Magnesium sulfate 250.0 mg.

    Excipients: sodium hydroxide 0.1 M solution - up to pH 6.2-8.0, water for injection - up to 1.0 ml.

    Description:

    Transparent colorless liquid.

    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), increases 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 block 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:

    If it is necessary to prescribe the drug during pregnancy / breastfeeding, the expected benefit for the mother and the potential risk for the year / child should be compared. The use of the drug is contraindicated in the prenatal period (2 hours before delivery).

    Dosing and Administration:

    Intravenously.

    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 after 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).Supportive dose - first - 1-2 grams per hour, later - 1 g per hour (you can enter drip 24-72 hours).

    Hypomagnesemia.

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

    In adults. A solution of magnesium sulfate is used parenterally if it is impossible or impractical 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.

    With hypertensive crises 5-20 ml of 25% solution of magnesium sulfate is injected / in (slowly !!).

    For arresting arrhythmias, I / O inject 1-2 g for about 5 minutes, possibly repeated administration.

    Doses of magnesium sulphate are indicated in grams.

    They correspond to the amount of solution: 1 g - 4 ml (25%); 2 g - 8 ml (25%); 3 g-12 ml (25%); 4 g - 16 ml (25%); 5 g-20 ml (25%); 10 g -40 ml (25%); 15 g -60 ml (25%); 20 g-80 ml (25%); 30 g - 120 ml (25%); 40 g -160 ml (25%).

    A solution of magnesium sulfate 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 easily 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, hypotensive drugs 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 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:

    Magnesium sulfate 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.

    When magnesium sulfate is administered, 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:During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Solution for intravenous administration 250 mg / ml.
    Packaging:

    5 ml or 10 ml in ampoules of colorless neutral glass type I with a colored break ring or with a colored dot and a notch or without a kink ring, a colored dot and a notch.

    One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding can additionally be applied to the ampoules.

    5 ampoules per circuit cell packaging made of polyvinylchloride film and aluminum foil foil or polymer film or without foil and without film.

    Or 5 ampoules in a prefabricated form (tray) made of cardboard with cells for laying ampoules.

    One or two contour squares or cardboard trays, together with an instruction for use and a scarifier or knife, ampoule, or without a scarifier and a knife ampoule in a cardboard package (bundle).

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the time specified on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000504 / 01
    Date of registration:02.04.2012 / 13.05.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.03.2018
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