MAGNESIUM SULFATE

4). Posology Dosage should be tailored according to the individual’s needs and responses and should be reduced in renal impairment. Plasma magnesium concentrations should be measured to determine the rate and duration of infusion and should be monitored throughout therapy.

8 mEq) magnesium ions. 1 mmol Mg2+.

Treatment of magnesium deficiency in proven hypomagnesaemia Adults:

Intravenous route: intravenous infusion: Up to 400 mL Magnesium sulfate 10% w/v solution in an infusion solution should be administered by slow intravenous infusion over a period of up to five days and titrated to clinical need. The usual regimen is 80 – 120 mL Magnesium sulfate 10% w/v solution in an infusion solution in the first 24 hours followed by 40 – 60 mL Magnesium sulfate 10% w/v solution in an infusion solution per day for 3 or 4 days, administered by intravenous infusion.

Children and adolescents:

Intravenous route: intravenous injection: Neonate 1 mL/kg bw Magnesium sulfate 10% w/v solution every 6 – 12 hours as required, to be given by intravenous injection over at least 10 minutes. 5 mL/kg bw Magnesium sulfate 10% w/v solution every 12 hours as required, to be given by intravenous injection over at least 10 minutes.

Adolescents 12– 17 years 10 mL Magnesium sulfate 10% w/v solution every 12 hours as required, to be given by intravenous injection over at least 10 minutes. Prevention of hypomagnesaemia in patients receiving total parenteral nutrition Adults: Intravenous route: intravenous infusion: 25 – 50 mL Magnesium sulfate 10% w/v solution daily, in an infusion solution, usual dose 30 mL Magnesium sulfate 10% w/v solution daily, in an infusion solution, to be given by intravenous infusion.

1 mL/kg Magnesium sulfate 10% w/v solution daily, in an infusion solution, to be given by intravenous infusion. 05 mL/kg Magnesium sulfate 10% w/v solution daily, in an infusion solution, to be given by intravenous infusion. Control and prevention of recurrent seizures in severe pre-eclampsia and eclampsia Adult women: Loading dose given by intravenous injection: An initial IV loading dose of approximately 40 – 50 mL Magnesium sulfate 10% w/v solution is administered over 5 – 15 minutes followed either by a maintenance intravenous infusion or regular IM injections for 24 hours, as follows: IV Maintenance Regimen The IV loading dose (above) is followed by an infusion of approximately 10 mL Magnesium sulfate 10% w/v solution per hour , in an infusion solution, for at least 24 hours after the last fit.

The frequency of undesirable effects is not known.

Immune system disorder:

Hypersensitivity reactions. Excessive administration of magnesium leads to the development of symptoms of hypermagnesaemia which may include: Metabolism and nutrition disorders Electrolyte/fluid abnormalities (hypophosphataemia, hypertonic dehydration) There have been isolated reports of maternal and fetal hypocalcaemia with high doses of magnesium sulfate.

Nervous system disorders Respiratory depression Nausea, vomiting, drowsiness and confusion Coma Slurred speech, double vision Loss of tendon reflexes due to neuromuscular blockade Cardiac disorders Cardiac arrhythmias, cardiac arrest ECG abnormal (prolonged PR, QRS and QT intervals), bradycardia Vascular disorders Flushing of the skin and hypotension due to peripheral vasodilatation Musculoskeletal and connective tissue disorders Muscle weakness General disorders and administration site conditions Thirst Especially in patients with impaired renal function, there may be sufficient accumulation of magnesium sulfate to produce toxic effects.

Injection/infusion-related Too rapid administration:

Vasodilatation, reduced blood pressure Local: may be irritant to veins; extravasation may cause tissue damage Intramuscular: pain, redness, swelling or warmth at the injection site, drainage at the injection site, prolonged bleeding, cellulitis, sterile abscess, signs of an allergic reaction, such as difficulty breathing or facial swelling, injury to nearby structures (blood vessels, bones, or nerves), inadvertent intravascular or intra-ostial injection, tissue necrosis, poor absorption due to high injectate volume.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Magnesium salts should be administered with caution to patients with impaired renal function and appropriate dosage reduction should be made. Serum calcium levels should be routinely monitored in patients receiving magnesium sulfate.

0 mmol). Monitoring of the absence of respiratory depression: the breath rate should not be under 16 breaths/min. 3). The presence of the patellar reflex should be checked. Administer with caution if flushing and sweating occurs. An antidote of injectable calcium gluconate solution should be immediately available.

2). Magnesium sulfate 10% w/v solution is not suitable for intramuscular use.

1. Hepatic encephalopathy, hepatic failure, renal failure. Severe renal impairment (glomerular filtration rate under 30 mL/h), anuria. Parenteral administration of the medicinal product is contraindicated in patients with heart block (class I-III) or myocardial damage and myasthenia gravis.