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MAGNESIUM SULFATE solution for injection 250 mg/ml
Instruction
For medical use of the medicinal product
Composition:
Active ingredient: magnesium sulfate heptahydrate;
1 ml of solution contains 250 mg of magnesium sulfate heptahydrate;
excipient: water for injections.
Dosage form.
Solution for injection.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group.
Blood substitutes and infusion solutions. Electrolyte solution. ATS code B05X A05.
Pharmacological properties.
Pharmacodynamics.
Magnesium is a physiological antagonist of calcium, a metabolic cofactor of most metabolic reactions, including those associated with the synthesis and release of energy, reduces the secretion of catecholamines, regulates the functioning of Na + -K + -ATPase, neurochemical transmission, muscle excitability, reduces the content of acetylcholine in the central nervous system, peripheral nervous system, as a result of which it exhibits sedative, analgesic, anticonvulsant, spasmolytic, choleretic and tocolytic effects. The drug dilates coronary and peripheral arteries, reduces blood pressure, afterload on the heart, inhibits the development of reperfusion injury to the myocardium. Reduces the frequency of ventricular and supraventricular arrhythmias, slows down conduction in the sinus and atrioventricular nodes.
Antiplatelet properties of magnesium are associated with a decrease in the synthesis of thromboxane A 2, lipoxygenase derivatives (12-HT), stimulation of the synthesis of prostacyclin and high-density lipoproteins. With increasing doses, magnesium can cause a negative isotropic and muscle relaxant effect.
Pharmacokinetics.
When administered parenterally, magnesium quickly enters organs and tissues, penetrates the blood-brain barrier, the placenta, and in high concentrations penetrates into breast milk. The drug is excreted mainly in the urine.
Systemic effects develop within 1 minute after intravenous administration and 1 hour after administration. The duration of action of magnesium with intravenous administration is 30 minutes, with intramuscular administration - 3-4 hours.
Clinical characteristics.
Indication.
Hypertensive crisis, ventricular heart rhythm disturbances (pirouette tachycardia); convulsive syndrome; eclampsia, hypomagnesemia, increased need for magnesium. in the complex therapy of premature birth, angina pectoris, in poisoning with heavy metal salts, tetraethyl lead, soluble barium salts (antidote).
Contraindication.
Increased individual sensitivity to the components of the drug; arterial hypotension; pronounced bradycardia (heart rate less than 55 beats per minute); atrioventricular block; conditions caused by calcium deficiency and depression of the respiratory center; cachexia; impaired renal function; pronounced hepatic or renal failure; myasthenia gravis; malignant neoplasms.
Interaction with other drugs and other types of interactions.
Calcium ions have an antagonistic effect on magnesium ions, which leads to a decrease in the pharmacological effects of magnesium sulfate when used simultaneously. The drug enhances the effect of drugs that depress the central nervous system (narcotics, analgesics). With the simultaneous use of muscle relaxants and nifedipine, neuromuscular blockade is enhanced. Simultaneous use with calcium channel blockers, such as nifedipine, can lead to a violation of calcium balance and impaired muscle function.
Barbiturates, narcotic analgesics and antihypertensives increase the likelihood of respiratory depression. Cardiac glycosides increase the risk of conduction disturbances and atrioventricular block.
The effect of antithrombotic agents, vitamin K antagonists, isoniazid, and nonselective monoamine reuptake inhibitors is reduced.
The elimination of mexiletine may be slowed, which may require a dose adjustment.
Propafenone - the effect of both drugs and the risk of toxic effects are enhanced.
Disrupts the absorption of tetracycline antibiotics, intestinal obstruction is possible, and weakens the effect of streptomycin and tobramycin.
Application features.
When using the drug, it should be taken into account that increased urinary magnesium excretion occurs with an increase in the volume of extracellular fluid, dilation of renal vessels, hypercalcemia, increased urinary sodium excretion, with the appointment of osmotic diuretics (urea, mannitol, glucose), "loop" diuretics (furosemide, ethacrynic acid, thiazides), with the administration of cardiac glycosides, calcitonin, thyroidin, with prolonged administration of deoxycorticosterone acetate (more than 3-4 days). Slowing down the excretion of magnesium is observed with the administration of parathyroid hormone. In renal failure, the excretion of magnesium slows down, and with repeated administrations, its content may increase. Therefore, in elderly patients and patients with severe renal impairment, the dose should not exceed 20 g of magnesium sulfate (81 mmol Mg 2+) within 48 hours; in patients with oliguria or severe renal impairment, magnesium sulfate should not be administered intravenously rapidly. Urinary tract infections accelerate the precipitation of ammonium-magnesium phosphates, and magnesium therapy is temporarily not recommended. In case of impaired magnesium excretion after parenteral administration of magnesium sulfate, hypermagnesemia is possible.
Use with caution in myasthenia gravis and respiratory diseases. With prolonged use of the drug, monitoring of the cardiovascular system, tendon reflexes, renal function and respiratory rate is recommended.
Intravenous administration of magnesium sulfate should be carried out slowly: if the rate of administration is too high, hypermagnesemia may occur (symptoms - nausea, paresthesias, sedation, hypoventilation up to apnea, decreased deep tendon reflexes). Simultaneous parenteral administration of vitamin B6 and insulin increases the effectiveness of magnesium therapy.
If simultaneous intravenous administration of magnesium sulfate and calcium preparations is necessary, they should be administered into different veins, taking into account that the level of magnesium depends on the level of calcium in the body.
Use during pregnancy or breastfeeding.
During pregnancy, magnesium sulfate should be used with extreme caution, taking into account the concentration of magnesium in the blood, and only in cases where the expected therapeutic effect outweighs the potential risk to the fetus. When providing analgesia during labor, the possibility of suppressing the contractile ability of the uterine muscles should be taken into account, which requires the use of agents that stimulate labor.
If necessary, use of the drug should stop breastfeeding.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Patients should be warned about the need to exercise caution when working with potentially dangerous mechanisms or driving vehicles, since the drug has a sedative effect.
Method of administration and doses
Administer intramuscularly, intravenously slowly or as an infusion. The frequency of administration and doses are individual depending on the indications and therapeutic effect. For infusion, dilute the drug with 0.9% sodium chloride solution or 5% glucose. For intravenous injection, the rate of administration should usually not exceed 150 mg/min (0.6 ml/min), except for the treatment of arrhythmia and eclampsia in pregnant women.
Prepared infusion solutions must be used immediately after preparation (cannot be stored).
Hypomagnesemia. For moderate hypomagnesemia (0.5-0.7 mmol/L), administer 4 ml (1 g magnesium sulfate) intramuscularly every 6 hours.
In severe hypomagnesemia (
The maximum daily dose for intravenous administration is 72 ml (18 g). If necessary, the infusion should be repeated within several days.
Arterial hypertension. In case of arterial hypertension of stage I-II, administer daily intramuscularly 5-10-20 ml. The course of treatment is 15-20 injections, while along with a decrease in blood pressure, a decrease in the severity of angina pectoris may be observed.
Hypertensive crisis. Administer 10-20 ml intramuscularly or intravenously slowly.
Cardiac arrhythmias. To stop arrhythmias, inject 4-8 ml (1-2 g of magnesium sulfate) intravenously over 5-10 minutes, if necessary, repeat the injection (total administration of up to 4 g of magnesium sulfate). It is possible to administer initially a loading dose of 8 ml over at least 5 minutes, followed by infusion of 20 ml of the drug diluted with 0.9% sodium chloride solution or 5% glucose over at least 6 hours, or initially 8 ml over at least 30 minutes, followed by infusion over at least 12 hours.
Ischemic stroke. 10-20 ml intravenously for 5-7 days.
Convulsive syndrome. Adults should be given 5-10-20 ml intramuscularly. Children should be given intramuscularly at the rate of 0.08-0.16 ml/kg of body weight (20-40 mg/kg).
Toxicosis of pregnant women. 10-20 ml 1-2 times a day intramuscularly (can be combined with simultaneous administration of neuroleptics).
Labor pain relief. 5-10-20 ml intramuscularly, if necessary, combine magnesium sulfate with analgesics.
Urinary retention. For urinary retention and lead colic, administer 5-10 ml of the drug intramuscularly or 5-10 ml of a 25% solution of magnesium sulfate diluted 5 times intravenously (also administer as an enema).
As an antidote. In case of intoxication with mercury, arsenic, tetraethyl lead, intravenously administer 5-10 ml of a 25% solution of magnesium sulfate diluted 2.5-5 times. In case of poisoning with soluble barium salts, administer 4-8 ml intravenously or wash the stomach with a 1% solution of magnesium sulfate.
Newborns. In case of intracranial hypertension and severe asphyxia in newborns, administer intramuscularly, starting with a dose of 0.2 ml/kg of body weight per day, increasing the dose on the 3rd-4th day to 0.8 ml/kg of body weight per day for 3-8 days in complex therapy. To eliminate magnesium deficiency in newborns, prescribe 0.5-0.8 ml/kg 1 time per day for 5-8 days.
Children.
The drug can be used in pediatric practice.
Overdose.
Symptoms: signs of hypermagnesemia in order of increasing serum magnesium concentration:
decreased deep tendon reflexes (2-3.5 mmol/l);
prolongation of the PQ interval and expansion of the QRS complex on the ECG (2.5-5 mmol / l);
loss of deep tendon reflexes (4-5 mmol/l);
depression of the respiratory center (5-6.5 mmol / l);
cardiac conduction disorders (7.5 mmol/l);
cardiac arrest (12.5 mmol/l).
In addition, hyperhidrosis, anxiety, inhibition, polyuria, uterine atony.
Treatment: specific antidote is calcium preparations (calcium chloride or gluconate), which should be administered intravenously slowly. In case of moderate hypermagnesemia, furosemide may be prescribed. Respiratory depression should be eliminated by intravenous administration of 5-10 ml of 10% calcium chloride solution, oxygen inhalation, artificial ventilation of the lungs. In severe cases, peritoneal dialysis or hemodialysis is indicated. The appointment of symptomatic agents that correct the functions of the cardiovascular and central nervous systems.
Adverse reactions.
From the cardiovascular system: arterial hypotension, bradycardia, palpitations, conduction disturbances, hot flashes/feelings of heat, prolongation of the PQ interval and expansion of the QRS complex on the ECG, arrhythmia, coma, cardiac arrest.
Respiratory system: shortness of breath, respiratory depression.
From the nervous system: headache, dizziness, general weakness, drowsiness, confusion, loss of consciousness, depressed mood, decreased tendon reflexes, diplopia, anxiety, speech disorders, tremor and numbness of the extremities.
Musculoskeletal system: muscle weakness.
Gastrointestinal tract: nausea, vomiting.
Allergic reactions: anaphylactic shock, angioedema, hyperthermic syndrome, chills.
Skin: hyperemia, itching, rash, urticaria, increased sweating.
From the urinary system: polyuria.
From the reproductive system and mammary glands: uterine atony.
Metabolic disorders: hypocalcemia, hypophosphatemia, hyperosmolar dehydration.
Injection site disorders: hyperemia, edema, pain.
Expiration date.
5 years.
Storage conditions.
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Incompatibility.
Pharmaceutically incompatible (precipitate is formed) with calcium preparations, ethanol (in high concentrations), carbonates, bicarbonates and phosphates of alkali metals, salts of arsenic acid, barium, strontium, clindamycin phosphate, hydrocortisone sodium succinate, polymyxin in sulfate, procaine hydrochloride, salicylates and tartrate. At concentrations of mg2 + above 10 mmol / ml in mixtures for total parenteral nutrition, stratification of fat emulsions is possible.
Packaging.
5 ml or 10 ml in an ampoule; 5 ampoules in a contour blister pack; 2 contour blister packs in a pack; 5 ml or 10 ml in an ampoule; 10 ampoules in a box; 5 ml in an ampoule; 5 ampoules in a contour blister pack sealed with paper.
Vacation category.
According to the recipe.
Producer.
PJSC "Halychpharm".
Location of the manufacturer and address of its place of business.
Ukraine, 79024, Lviv, Opryshkivska St., 6/8.
