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

    Composition of the preparation per 1 ml:

    Active substance:

    Magnesium sulfate heptahydrate 250 mg.

    Excipients:

    1 M solution of sodium hydroxide - to pH 5.5 - 0.8.

    Water for injection - up to 1 ml.

    Description:

    Transparent colorless liquid.

    Pharmacotherapeutic group:Vasodilator
    ATX: & nbsp

    A.12.C.C   Preparations of magnesium

    Pharmacodynamics:

    When parenteral administration has anticonvulsant, antiarrhythmic, antihypertensive effect, spasmolytic effect, in large doses inhibits neuromuscular transmission, has tocolytic effect, inhibits 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 ions through the presynaptic membrane, reduces the amount of acetylcholine in the peripheral nervous system and the central nervous system. Relaxes smooth muscles, lowers blood pressure (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.

    Antiarrhythmic action 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 current of calcium ions and a unilateral potassium current.

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

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

    Systemic effects develop almost instantly after intravenous administration. Duration of action with intravenous injection - 30 minutes.

    Pharmacokinetics:

    The equilibrium concentration of Css is 2-3.5 mmol / l. It penetrates the blood-brain barrier and the placental barrier, creating concentrations in breast milk that are 2 times higher than those in plasma. Excretion by the kidneys, its speed 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 with severe preeclampsia, to remove severe uterine contractions), poisoning with salts of heavy metals (mercury, arsenic, tetraethyl lead), hypomagnesemia (including an increased demand for magnesium and acute hypomagnesemia).

    Contraindications:

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

    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:

    The use of the drug during pregnancy and lactation is possible only according to the doctor's prescription, if the intended benefit for the mother exceeds the potential risk to the fetus or the baby.

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

    Dosing and Administration:

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

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

    Hypomagnesemia.

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

    In adults. Lightweight. A solution of magnesium sulfate is used parenterally if it is impossible to take magnesium preparations (due to nausea, vomiting, impaired resorption in the stomach, etc.) in a daily dose of 1-2 g. This dose is administered once or in 2-3 doses. Heavy. The initial dose is 5 g, which is delivered to 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 5-20 ml of a solution of magnesium sulfate 250 mg / ml are slowly administered intravenously.

    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).

    The procedure for working with a polymer ampoule:

    1. Take the ampoule and shake it, holding it by the neck.

    2. Squeeze the ampoule by hand, while there should not be a release of the drug. and rotate the movements and turn off the valve.

    3.After the opening, immediately connect the syringe with the ampoule.

    4.Turn the ampoule and slowly enter the contents into the syringe.

    5. Put the needle on the syringe.

    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.

    Symptoms of hypermagnesia, ranked in order of increasing the content of magnesium ions in the blood serum: a decrease in deep tendon reflexes (2-3.5 mmol / l), an extension of the PQ interval and expansion of the QR.S complex on an electrocardiogram (2.5-5 mmol / L) , loss of deep tendon reflexes (4-5 mmol / L), depression of the respiratory center (5-6.5 mmol / L), conduction of heart failure (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 with 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:

    Intravenously slowly enter 10% calcium chloride or calcium gluconate solution - 5-10 ml, carry out oxygene therapy, inhalation of carbogen, 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 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 tetracycline antibiotics, weakens the effects 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 . When the magnesium ions are higher than 10 mmol / ml in mixtures for complete 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 (CC greater than 20 mL / min) 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. Recommended control content of magnesium ions in the blood serum (to be not higher than 0.8-1.2 mmol / l), urine output (at least 100 ml / h), respiratory rate (not less than 16 / min), the blood pressure should be monitored tendon reflexes.

    When parenteral use, special care should be taken not to create toxic concentrations of the drug. Elderly patients often require a lower 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 period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:Solution for intravenous administration 250 mg / ml.
    Packaging:

    5 or 10 ml vials in a low density polyethylene or polypropylene (Politvist) with the twist cap for a needlelessfence of the drug.

    For 5 or 10 ampoules together with instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of ns above 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date!

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002860
    Date of registration:16.02.2015
    Expiration Date:16.02.2020
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.03.2018
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