Magnesium sulfate-Darnitsa - instructions for use, dose, side effects, contraindications

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" blocker of slow calcium channels 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 central nervous system. Relaxes smooth muscles, lowers blood pressure (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.
Cardioprotective effect is due to the expansion of the coronary arteries, a decrease in the total peripheral resistance of blood vessels and platelet aggregation.
Tokoliticheskoe action - magnesium inhibits the contractility of the myometrium (decrease - absorption, binding and distribution of calcium in the cells of smooth muscles), 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 administration. Duration of action with intravenous injection - 30 minutes.

Pharmacokinetics:Passes through the blood-brain barrier and placenta, creates in the milk concentrations of 2 times the concentration in the plasma. Anticonvulsant median equilibrium concentration is 2-3.5 mmol / l. The drug is excreted 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 in severe pre-eclampsia, to relieve severe contractions of the uterus), poisoning salts of heavy metals (mercury, arsenic, tetraethyl lead), hypomagnesium (including increased demand for magnesium and acute hypomagnesemia-tetany).

Contraindications:- Hypersensitivity;
- severe arterial hypotension;
- depression of the respiratory center;
- bradycardia, atrioventricular block;
- Myasthenia gravis;
- menstruation;
- severe renal failure (creatinine clearance less than 20 ml / min);
- prenatal period (2 hours prior to delivery)

Carefully:Diseases of the respiratory system, chronic renal failure (if creatinine clearance is more than 20 ml / min), acute inflammatory diseases of the gastrointestinal tract, pregnancy.
With prolonged treatment, it is recommended to monitor blood pressure, heart activity, tendon reflexes, kidney function, respiratory rate. If it is necessary to simultaneously use intravenous magnesium and calcium salts, they should be injected into different veins.

Pregnancy and lactation:In pregnancy magnesium sulfate use with caution, taking into account the concentration of magnesium in the blood, in cases where the expected therapeutic effect exceeds the potential risk to the fetus. In the anesthesia of childbirth, the possibility of suppressing the contractile capacity of the uterine muscles should be taken into account, which requires the use of rhythm-stimulating agents.
If it is necessary to use during breastfeeding, breastfeeding should be discontinued.

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 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 ml / kg intravenously slowly.
In adults. Easy. 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.). The daily dose is 1-2 g. This dose is administered once or in 2-3 doses. Heavy. The initial dose is 5 g, which is added 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.
When hypertensive crises are administered intravenously (slowly!) 1,25-5 grams of magnesium sulfate.For arrhythmia arrest intravenously 1-2 g for about 5 minutes, possibly repeated administration.
Doses of magnesium sulfate - Darnitsa are indicated in grams. They correspond to the amount of 25.% solution: 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).
Children.
It should be borne in mind that in newborns, delayed excretion of magnesium, so if the speed of administration and dose of the drug is exceeded, hypermagnesia is possible, although this complication rarely develops on the whole.

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 on 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, lowering of blood pressure, nausea, shortness of breath,greased 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), inhibition of the respiratory center (5-6.5 mmol / l), impaired conduction of the heart (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: intravenously slowly, a solution of calcium chloride or calcium gluconate - 5-10 ml 10% Oxygen therapy, carbogen inhalation, artificial respiration, peritoneal dialysis or hemodialysis, symptomatic therapy.

Interaction:Patients who, together with magnesium sulfate, use other medicines, should inform the doctor about this.
Strengthen the effect of other drugs that depress the central nervous system. Cardiac glycosides increase the risk of conduction disruption and AV blockade (especially with simultaneous in / in the 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 gobramycip.
Calcium salts reduce the effect of magnesium sulfate.
Pharmaceutically incompatible 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 tartrates . At concentrations of magnesium ions above 10 mmol / ml in mixtures for total parenteral nutrition, fat emulsion separation is possible.

Special instructions:It should be borne in mind that in / m injections are extremely painful and lead to the formation of infiltrates.
Magnesium sulfate - Darnitsa should be used carefully so that the toxic concentration of the drug does not arise. Elderly people should usually take a reduced dose,
because they have decreased kidney function. Freeloaders 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 induction, for example, a calcium gluconate solution of 100 mg / ml. 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.

Form release / dosage:Solution for intravenous administration.

Packaging:

5 ml into glass ampoules.

It is allowed to paste a label with self-adhesive paper on the ampoule.

5 ampoules with a knife for opening ampoules in a contour mesh package (cassette).

Two contour packs with instructions for medical use in a pack.

For 10 ampoules together with instructions for medical use and a knife for opening ampoules in a box with a corrugated liner. Boxes are pasted with a label-parcel post.

When packaging ampoules with a colored ring or break point, the knives for opening ampoules are not invested.

Storage conditions:

Keep out of reach of children, at a temperature of 5 ° C to 25 ° C.

Do not freeze.

Shelf life:

5 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N010669

Date of registration:19.09.2012 / 07.07.2014

Expiration Date:Unlimited

The owner of the registration certificate:DARNITSA PHARMACEUTICAL FIRM, CJSCDARNITSA PHARMACEUTICAL FIRM, CJSC Ukraine

Manufacturer: & nbsp

DARNITSA PHARMACEUTICAL FIRM, PAO Ukraine

Information update date: & nbsp19.09.2012

Illustrated instructions

Instructions

Magnesium sulfate-Darnitsa (Magnesium sulfate-Darnitsa)