MAGNESIUM SULFATE

Magnesium Sulfate 10% w/v solution may be administered by intravenous or subcutaneous routes (see Method of administration below). 1 mEq or approximately 4 mmol magnesium (Mg2+). Therapeutic levels are reached almost immediately with appropriate intravenous doses.

Adults Hypomagnesaemia The dose is strictly individual. As a general guideline, 8-12 g of magnesium sulfate (32-48 mmol Mg2+) can be administered in the first 24 hours followed by 4-6 g (16-24 mmol Mg2+) per day for 3 or 4 days, to replete body stores.

Maximum infusion rates should not exceed 2 g/hour (8 mmol Mg2+/hour). 4 mmol/l. 5 ml/minute) or, exceptionally, subcutaneously (painful), repeatedly if necessary. Severe pre-eclampsia or eclampsia Intravenously an initial loading dose of 4-5 g of magnesium sulfate (16-20 mmol Mg2+) diluted to an appropriate volume may be infused.

4). Therapy should continue until paroxysms cease. Paediatric population Hypomagnesaemia Magnesium Sulfate 10% w/v solution may be administered intravenously to children. 001 g/kg/minute magnesium). Renal insufficiency Patients with renal insufficiency should receive 25-50% of the initial dose recommended for patients with normal kidney function.

ECG monitoring is recommended with high doses and in the elderly. Hepatic impairment No special dosage instructions are available. Elderly Parenteral magnesium sulfate should be used with caution in the elderly because renal and/or hepatic disorders are more frequent in this age group and the tolerance to adverse effects may be lower.

Method of administration For intravenous or subcutaneous injection or infusion.

Intravenous (IV):

For intravenous injection, the 10% w/v solution does not require dilution. For intravenous infusion, the medicinal product should be diluted.

Subcutaneous (SC):

For subcutaneous administration, the medicinal product should be diluted. Magnesium Sulfate 10% w/v solution is not appropriate for intramuscular administration. For intramuscular injection and in case the IV loading/IM maintenance regimen above is applied, Magnesium Sulfate 50% w/v solution should be used.

6.

The frequency of undesirable effects is not known (cannot be estimated from the available data). Immune system disorders As with all medicines, hypersensitivity reactions cannot be ruled out. Excessive administration of magnesium leads to the development of symptoms of hypermagnesaemia which may include: Metabolism and nutrition disorders Electrolyte/fluid abnormalities (hypophosphatemia, hypertonic dehydration).

6). 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 effects Too rapid administration: quickly developing vasodilatation, reduced blood pressure.

Local: as all parenteral medicines, magnesium sulfate injections 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 injection volume have been described for other magnesium sulfate solutions for injection.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

2). Magnesium sulfate should not be used in hepatic coma if there is a risk of renal failure. Serum calcium levels should be routinely monitored in patients receiving magnesium sulfate. The serum magnesium level should be monitored during the treatment.

Monitoring of the absence of respiratory depression: the breath rate should not be under 16 breaths/min. The excretion of urine should not be under 25 ml/h, as it could lead to hypermagnesaemia. The presence of the patellar reflex should be checked.

The medicine should be administered with caution if flushing and sweating occurs. An antidote of injectable calcium gluconate solution should be immediately available.

1. − Hepatic encephalopathy, hepatic failure. − Severe renal impairment (glomerular filtration rate <25 ml/h), renal failure, anuria. − Parenteral administration of the medicinal product is contraindicated in patients with heart block (class I-III) or myocardial damage and myasthenia gravis.