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

    Per 1 ml:

    Active substance: magnesium sulfate 250 mg.

    Excipient: 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, 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. It 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.

    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 cardiomyocytes, restores ion balance, stabilizes cell membranes, breaks sodium current, slow incoming calcium current and unilateral potassium current.

    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) is 2-3.5 mmol / l.Penetrates through the blood-brain and placental barriers, creates concentrations in breast milk that are 2 times higher than those in the blood plasma.

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

    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 components of the drug; severe arterial hypotension; depression of the respiratory center; severe bradycardia; atrioventricular block (AV blockade) I-III degree; severe chronic renal failure (if creatinine clearance is less than 20 mL / min); pre-natal period (2 hours prior to delivery), conditions associated with calcium deficiency.

    Carefully:

    Myasthenia gravis, chronic renal insufficiency (if creatinine clearance is 20-60 ml / min), respiratory diseases, acute inflammatory diseases of the gastrointestinal tract, pregnancy, lactation, children under 18, elderly.

    Pregnancy and lactation:

    The use of the drug during pregnancy and during breastfeeding is possible only if prescribed by the doctor, if the intended benefit to the mother exceeds the potential risk to the fetus or baby.

    Dosing and Administration:

    Intravenously.

    Doses are refined taking into account the therapeutic effect and the content 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. Lightweight. Magnesium sulfate apply parenterally if it is impossible or unreasonable to ingest magnesium preparations (due to nausea, vomiting, impaired resorption in the stomach, etc.).

    In adults. Heavy. The initial dose is 5 g IV slowly in 1 L infusion solution. Dosed depending on the content of magnesium ions in 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.

    When hypertensive crises are administered intravenously (slowly!) 5-20 ml 250 mg / ml Magnesium sulfate.

    To stop the arrhythmias, intravenously inject 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: 1 g - 4 ml (250 mg / ml); 2 g - 8 ml (250 mg / ml); 3 g-12 ml (250 mg / ml); 4 g - 16 ml (250 mg / ml); 5 g - 20 ml (250 mg / ml); 10 g - 40 ml (250 mg / ml); 15 g - 60 ml (250 mg / ml); 20 g - 80 ml (250 mg / ml); 30 g - 120 ml (250 mg / ml); 40 g - 160 ml (250 mg / ml).

    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 face, headache, lowering blood pressure, nausea, dyspnea, blurred speech, vomiting, asthenia.

    Symptoms of hypermagnesia, ranked in order of increasing magnesium content 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), loss of deep 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).

    In addition, 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, "sharp" decrease in blood pressure, bradycardia, respiratory depression and central nervous system activity.

    Treatment: should slowly and slowly inject a solution of calcium chloride or calcium gluconate - 5-10 ml 10%, produce 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.

    Magnesium sulfate enhances 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 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:

    Magnesium sulfate should be used carefully so that the toxic concentration of the drug does not appear. Elderly patients 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 intravenously 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 you administer Magnesium sulfate, you need to have a calcium solution prepared for intravenous administration, for example a 10% solution of calcium gluconate.

    When applying Magnesium sulfate, the results of radiological studies for which technetium is applied may be distorted.

    With prolonged use of magnesium sulfate, monitoring of arterial pressure, heart activity, tendon reflexes, kidney activity, respiratory rate is recommended.

    If it is necessary to simultaneously enter calcium and magnesium salts, the drugs should be injected into different veins.

    Effect on the ability to drive transp. cf. and fur:In connection with the fact that the drug in large doses depresses the neuromuscular transmission during the treatment period, care must be taken when driving vehicles and engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Solution for intravenous administration 250 mg / ml.
    Packaging:

    In ampoules of 5 ml or 10 ml.

    10 ampoules together with the instruction for use are placed in a pack of cardboard.

    5 ampoules are placed in a contour mesh package. 2 contour mesh packages along with the instruction for use are placed in a pack of cardboard.

    In each pack insert knife ampoule or scarifier.

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

    Storage conditions:

    In the dark place at a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-007956/08
    Date of registration:08.10.2008 / 20.10.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:Armavir Biofactory, FKPArmavir Biofactory, FKP Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.03.2018
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