Active substanceMagnesium sulfateMagnesium sulfate
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  • Dosage form: & nbsp

    solution for intravenous administration

    Composition:

    Active substance: magnesium sulfate heptahydrate - 250.0 mg;

    adjuvant: 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 anticonvulsant, antiarrhythmic, hypotensive, antispasmodic effect, in large doses depresses neuromuscular transmission, has tocolytic 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 muscular excitability,prevents the entry of calcium through the presynaptic membrane, reduces the amount of acetylcholine in the peripheral nervous system and the central nervous system (CNS). Relaxes smooth muscles, lowers blood pressure (BP) (mostly increased), increases diuresis.

    The mechanism of anticonvulsant action is associated with a decrease in the release of acetylcholine from neuromuscular synapses, while magnesium suppresses neuromuscular transmission, has a direct inhibitory effect on the central nervous system.

    The antiarrhythmic effect of magnesium is due to a decrease in the excitability of cardiomyocytes, the restoration of ionic equilibrium, the stabilization of cell membranes, the violation of sodium current, a slow incoming calcium current and a unilateral potassium current.

    The cardioprotective effect is due to the expansion of the coronary arteries, the loss of total peripheral vascular resistance and platelet aggregation.

    The tocolytic action develops as a result of inhibition of the contractility of the myometrium (decrease in absorption, binding and distribution of calcium in smooth muscle cells) under the influence of magnesium ions,increased blood flow in the uterus as a result of the expansion of its vessels.

    Magnesium is an antidote for poisoning with salts of heavy metals.

    Systemic effects after intravenous administration develop almost instantaneously. The duration of action is 30 minutes,

    Pharmacokinetics:

    The equilibrium concentration (Css) is 2-3.5 mmol / l. Penetrates through the blood-brain and placental barriers, creates in the mother's milk concentrations of 2 times higher than those 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 convulsions with severe preeclampsia, to remove severe uterine contractions), poisoning salts of heavy metals (mercury, arsenic, tetraethyl lead), hypomagnesium (including an increased demand for magnesium and acute hypomagnesemia).

    Contraindications:

    Hypersensitivity to the components of the drug, severe arterial hypotension, oppression of the respiratory center,severe breechnic insufficiency (creatinine clearance less than 20 ml / min), prenatal period (2 hours prior to delivery), conditions associated with calcium deficiency, severe bradycardia, atrioventricular blockade (AV blockade of MI degree), severe chronic renal failure.

    Carefully:
    Myasthenia gravis, chronic renal failure (if creatinine clearance is more than 20 ml / min), respiratory diseases, acute inflammatory diseases of the gastrointestinal tract, pregnancy, advanced age, lactation, age 18 years.
    Pregnancy and lactation:

    In pregnancy magnesium sulfate use with caution only when the expected therapeutic effect for the mother exceeds the potential risk to the fetus.

    Preeclampsia and eclampsia. 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). The maintenance dose is first -1 -2 g per hour, later - 1 g per hour (it can be administered drip 24-72 h).

    If you need to use the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Intravenously slow.

    Doses are refined taking into account the therapeutic effect and the content of magnesium ions in the blood serum.

    Hypomagnesemia

    In newborns. The daily dose is 0.2-0.8 ml / kg intravenously, slowly.

    In adults

    Lightweight. The daily dose of 1-2 g.

    Heavy. The initial dose is 5 g, which is poured into 1 liter of infusion solution and slowly administered intravenously. 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 Introduce intravenously (slowly!) 5-20 ml of a solution of magnesium sulfate 250 mg / ml.

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

    Doses of magnesium sulfate are indicated in grams. They correspond to the amount of solution of 250 mg / ml: 1 g - 4 ml; 2 g - 8 ml, 3 g - 12 ml; 4 g - 16 ml; 5 g - 20 ml; 10 g - 40 ml; 15 g - 60 ml; 20 g - 80 ml; 30 g - 120 ml; 40 g - 160 ml. A solution of magnesium sulfate in ampoules is diluted with injection solutions: 0.9% sodium chloride or 5% dextrose (glucose).

    Side effects:

    Early signs and symptoms of hypermagnesemia: bradycardia, diplopia, sudden "tide" of blood to the skin of the face, headache, lowering of blood pressure, nausea, shortness of breath, lubricated speech, vomiting, asthenia.

    The signs 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) Deep tendon reflexes (jl-5 mmol / l), respiratory center depression (5-6.5 mmol / l), conduction disturbance of the heart (7.5 mmol / l), cardiac arrest (12.5 mmol / l).

    Hyperhidrosis, anxiety, deep sedation, polyuria, atony of the uterus.

    The drug lowers the excitability of the respiratory center, large doses of the drug in parenteral administration can cause paralysis of the respiratory center

    Overdose:

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

    Treatment: 10% calcium chloride or calcium gluconate solution is slowly injected intravenously - 5-10 ml, oxygen therapy, carbogen inhalation, artificial respiration, peritoneal dialysis or hemodialysis, symptomatic therapy.

    Interaction:

    Strengthens the effect of other drugs that depress the central nervous system.

    Cardiac glycosides increase the risk of conduction disruption and atrioventricular (AV) 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 with calcium preparations, ethanol (in high concentrations), carbonates, hydrogen carbonates and phosphates of alkali metals, arsenic acid, barium, strontium, 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:

    If it is necessary to simultaneously administer intravenous magnesium and calcium salts, they are injected into different veins.

    It is possible to use magnesium sulfate for relief of epileptic status (as part of complex therapy).

    Patients with severe renal dysfunction should not receive more than 20 g of magnesium sulfate (81 mmol Mg2+) for 48 hours, patients with oliguria or severe renal dysfunction should not be administered magnesium sulfate intravenously too fast. It is recommended to control the concentration of magnesium ions in blood serum (should not be higher than 0.8-1.2 mmol / l), diuresis (not less than 100 ml / 4 h), respiratory rate (not less than 16 / min), blood pressure.

    When parenteral use, special care should be taken not to create toxic concentrations of the drug. Elderly patients often require a reduction in dose (weakened kidney function).

    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, care must be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Solution for intravenous administration 250 mg / ml.

    Packaging:

    5 ml into neutral glass ampoules.

    5 or 10 ampoules per contour cell pack of a polyvinyl chloride film.

    1 circuit cell pack of 10 ampoules or 2 contour packs of 5 ampoules with instructions for use, a scarifier or a knife ampoule in a pack of cardboard.

    When using ampoules with a ring or break point, the scarifier or ampoule knife is not inserted.

    Storage conditions:

    In the 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 expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000167
    Date of registration:23.04.2010 / 27.04.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Company DEKO, LLC Company DEKO, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.03.2018
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