Magnesium sulfate solution for injections 25%

Magnesium sulfate solution for injections 25%

Active substance (International non-licensed name):

magnesium sulfate

АТС code: В05ХА05

Pharmacotherapeutic group:

Antihypertensive agent

 

 

Pharmacologic properties

With parenteral administration it has sedative, diuretic, arterial dilatation, anticonvulsive, antiarrhythmic, hypotensive, spasmolytic, in large doses - curariform (depressant effect on neuromuscular transmission), tocolytic, sleeping pills and narcotic effect, suppresses the respiratory center. Regulates metabolic processes, interneuronal transmission and muscular excitability, prevents Ca2+ entry through presynaptic membrane, reduces the amount of acetylcholine in the peripheral nervous system and central nervous system. It relaxes smooth muscles, reduces blood pressure (especially high), increases diuresis. Anticonvulsant action - Mg2+ reduces the release of acetylcholine from the neuromuscular synapses, while suppressing neuromuscular transmission, has a direct dampening effect on the central nervous system. Antiarrhythmic action - Mg2+ reduces the excitability ofcardiomyocytes, restores the ion balance, stabilizes cell membranes, violates the Na+ current, slow incoming Ca2+ currentand unilateral K+ current. Cardioprotective effect is due to enlargement of coronary arteries, decrease of TPVR and platelet aggregation. Tocolytic effect - Mg2+ inhibits the ability of myometrial contractility (decrease in absorption, binding and distribution of Ca2+ in smooth muscle cells), increases blood flow to the uterus as a result of the expansion of its vessels. It is the antidote for poisoning by heavy metal salts. Systemic effects are developed almost immediately after intravenous and 1 h after intramuscular injection. Duration of action with intravenous injection - 30 min, intramuscular - 3-4 h.

Indications

Arterial hypertension (including hypertensive crisis with signs of brain edema), the threat of premature labor, convulsions in gestosis, hypomagnesemia (including an increased need for magnesium and acute hypomagnesemia - tetanilla, violation of the myocardium), polymorphic ventricular tachycardia, eclampsia, encephalopathy, epileptic syndrome, urinary retention. Poisoning by salts of heavy metals (mercury, arsenic, tetraethyl lead, barium).

Method of application and dosage

In essential hypertension stage I-II for 5 - 10 - 20 ml of 20% or 25% solution of the drug is injected intramuscularly daily. The course of treatment - 15 - 20 injections. In this case, along with a reduction in blood pressure, reduced severity of angina may be observed. In hypertensive crisis 10 - 20 ml of 20 - 25% solution is injected intramuscularly or intravenously jet (slowly). For anesthesia delivery with 5 - 10 - 20 ml of 25% solution is injected intramuscularly, if necessary Magnesium sulfate-Darnitsa is combined with analgesics.  In the late toxicosis of pregnant 1-2 times a day intramuscularly 10-20 ml of 25% solution of the drug (can be combined with simultaneous appointment of neuroleptics) is introduced. In convulsive states 5 - 10 - 20 ml of 25% of solution is intramuscularly injected. With lead colic and urination delay 5 - 10 ml of 10 - 20% solution is injected intramuscularly, and intravenously - 5 - 10 ml of 5% solution (as prescribed in the form of enemas). As cholagogue agent, appointed interior and 1 tablespoon of 20 - 25% solution 3 times a day. For duodenal sounding injected through a tube 50 ml of warm 25% solution. To eliminate the deficit of magnesium in baby’s body 25% solution of 0,5 - 0,8 ml / kg of body weight once a day for 5-8 days is designated; children with severe hypoxia at birth are introduced from 0,2 ml / kg , increasing to 3 - 4 day a dose of up to 0,8 ml / kg. At intravenous infusion of fluids kids need to be added 25% solution of magnesium sulfate at a daily dose of 0,5 - 0,75 mmol / kg (in 1 ml of solution 1 mmol of magnesium is contained), spreading it evenly throughout the volume of instilled solution.

Side effects

Early signs and symptoms of  hypermagiaemia: bradycardia, diplopia, sudden "surge" of blood to the skin of the face, headache, decrease of blood pressure, nausea, shortness of breath, vomiting, asthenia. Signs of hypermagiaemia, ranked in order of increasing concentration of  Mg2+ in serum: reduction of deep tendon reflexes (2-3.5 mmol / l), P-Q interval prolongation and expansion of QRS complex on ECG (2.5-5 mmol / l), loss of deep tendon reflexes (4 -5 mmol / l), inhibition of the respiratory center (5-6.5 mmol / l), cardiac conduction disturbances (7.5 mmol / l), heart failure (12.5 mmol / l). In addition, hyperhydrosis, anxiety, polyuria, uterine atony.

Contraindications

Hypersensitivity, hypotension, depression of the respiratory center, marked bradycardia, AV block, pre-natal period (2 hours before delivery). Use with caution.

Special instructions

If simultaneous intravenous administration of salts of Mg2+ and Ca2+ is necessary, they are entered in different veins. The use of magnesium sulfate for relief of epileptic status is possible (in the complex therapy). Patients with severe renal dysfunction should not receive more than 20 grams of magnesium sulfate (81 mmol Mg2+) for 48 h, in patients with oliguria or severe renal dysfunction magnesium sulphate in / should not be introduced too fast. It is recommended to control the concentration of Mg2+ in serum (should not be higher than 0.8-1.2 mmol / l), diuresis (not less than 100 ml / 4 h), respiration rate (not less than 16/min), blood pressure. When use parenteral, should be very careful not to create a toxic concentrations of the drug. Older patients often require dose reduction (attenuation of renal function). An injection can also be used for ingestion (as a purgative drug). In case of overdose causes CNS depression. As an antidote to an overdose medication calcium drugs are used - calcium chloride or calcium gluconate.

Product

25% solution for injections, 5 ml and 10 ml in ampoules, 5 ampoules in blister, to 2-outline packages in a cardboard box.

Storage conditions

To be kept in a dry and protected from light place at the temperature not above 25°С.

Shelf life

3 years

Dispensed with a prescription

Not to be used after the expiry date indicated on the package To be stored out of the reach to children