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Magnesium Sulphate 50% Solution for Injection 2ml (Single Vial)

Magnesium Sulphate 50% Solution for Injection 2ml (Single Vial)

Misc (Generics)

Prescription-only injectable medicine
  • Authorised as a prescription Only medicine by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for parenteral magnesium replacement and related indications.
  • Manufactured in facilities operating in compliance with EU and UK Good Manufacturing Practice (GMP) standards for sterile injectable medicines.
  • Formulation and labelling conform to MHRA and European requirements for high Strength injectable electrolytes, including expression of strength and content in mmol.
  • Supported by an MHRA Licensed Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for Magnesium Sulfate 50% w/v solution for injection/infusion.
Magnesium supplementation / anticonvulsant (IM/IV solution)

Description

Magnesium Sulphate 50% Solution for Injection (2 ml single vial) is a concentrated sterile solution of magnesium sulphate heptahydrate intended for parenteral administration in hospital and clinical settings. Each 2 ml vial contains a high-strength 50% w/v (500 mg/mL) solution, providing a rapid and reliable source of magnesium when urgent correction of magnesium deficiency or magnesium-dependent clinical indications is required. The solution may be administered by slow intravenous injection, intravenous infusion after dilution, or deep intramuscular injection by a suitably qualified healthcare professional. It is commonly used for the management of severe hypomagnesaemia, the prevention and control of seizures associated with eclampsia and severe pre-eclampsia in pregnancy, certain magnesium-responsive cardiac arrhythmias, and as adjunctive therapy in acute severe asthma under specialist supervision. Due to its high concentration, dosing must be carefully calculated and monitored, and intravenous use requires prior dilution in an appropriate carrier fluid. This medicine is strictly for professional use only and must be administered in settings where appropriate monitoring, resuscitation equipment and expertise are available.

Bnefits

  • Provides a concentrated 50% w/v (500 mg/mL) source of magnesium for rapid correction of magnesium deficiency when oral replacement is not appropriate.
  • Suitable for use in the management of severe hypomagnesaemia, including in critically ill patients where prompt parenteral therapy is required.
  • Indicated for prevention and control of seizures in severe pre-eclampsia and eclampsia under specialist obstetric supervision.
  • Can be used as an adjunct in the management of certain cardiac arrhythmias where magnesium deficiency or magnesium responsiveness is implicated, according to clinical guidelines.
  • Employed as adjunctive therapy in acute severe asthma in hospital settings, where intravenous magnesium may help bronchodilation under monitored conditions.
  • High-strength single 2 ml vial presentation supports accurate dose preparation and flexible use as either diluted IV infusion or IM injection.
  • Manufactured to Good Manufacturing Practice (GMP) standards and authorised by the MHRA, providing assurance of quality, sterility and batch-to-batch consistency.

Indications

  • Treatment of proven magnesium deficiency (hypomagnesaemia) in adults, adolescents and children when oral magnesium therapy is not suitable or insufficient.
  • Prevention and treatment of hypomagnesaemia in patients at risk, such as those receiving total parenteral nutrition or with conditions causing significant magnesium loss.
  • Control and prevention of seizures in severe pre-eclampsia.
  • Control and prevention of recurrent seizures in eclampsia.
  • Adjunctive treatment of certain cardiac arrhythmias where magnesium therapy is clinically indicated and under specialist supervision.
  • Adjunctive therapy in acute severe asthma (status asthmaticus) in hospital or emergency settings, where intravenous magnesium sulphate is included in protocol-based management.

Composition

  • Active ingredient: Magnesium sulphate heptahydrate 50% w/v (500 mg/mL).
  • Each 2 mL vial contains 1,000 mg of magnesium sulphate heptahydrate, providing approximately 4 mmol of magnesium ions (Mg2+) and 4 mmol of sulphate ions.
  • Excipients: Water for Injections; some licensed products may also contain small amounts of sodium hydroxide or sulphuric acid for pH adjustment.
  • Sterile, clear, colourless solution intended for parenteral use only.

Formulation

  • Pharmaceutical form: Solution for injection or concentrate for solution for infusion.
  • Concentration: 50% w/v magnesium sulphate (500 mg/mL).
  • Routes of administration: Slow intravenous injection, intravenous infusion after appropriate dilution, or deep intramuscular injection.
  • Single-use 2 mL glass vial designed for aseptic withdrawal and immediate use by healthcare professionals.

Packaging

  • Presentation: Single 2 mL clear glass vial containing 50% w/v magnesium sulphate solution for injection.
  • Vials are typically packaged in cartons; hospital supply may be as single vials or multi-vial cartons depending on wholesaler configuration.
  • Vials are intended for single use only; any unused portion must be discarded.
  • Labelling includes strength, route of administration, batch number and expiry date in accordance with MHRA requirements.

Usage

  • For use only by suitably qualified healthcare professionals in hospital or appropriately equipped clinical settings.
  • May be administered by slow intravenous injection, by intravenous infusion after dilution in a compatible solution (such as 0.9% sodium chloride or 5% glucose), or by deep intramuscular injection, according to the Summary of Product Characteristics (SmPC) and local clinical protocols.
  • The solution must be diluted before intravenous infusion, and the rate of administration should be controlled to avoid rapid bolus dosing except where specifically recommended by guidelines.
  • Dose and route of administration must be individualised based on indication, patient age, body weight, renal function, and serum magnesium levels, and must follow current SmPC and specialist guidance.
  • During treatment, patients should be closely monitored for blood pressure, respiratory rate, oxygen saturation, deep tendon reflexes, cardiac rhythm, urine output and serum electrolytes (particularly magnesium and calcium).
  • Use with caution and usually reduced doses in patients with renal impairment; magnesium accumulation and toxicity are more likely when renal clearance is reduced.
  • Do not mix in the same syringe or infusion line with other medicinal products unless compatibility is known.
  • Intended for single use only; once the vial is opened and the dose prepared, any remaining solution must be discarded.

Contraindications

  • Known hypersensitivity to magnesium sulphate, magnesium salts or any excipient in the formulation.
  • Severely impaired renal function, renal failure or anuria, due to the risk of magnesium accumulation and toxicity.
  • Heart block or significant conduction disturbances where further depression of cardiac conduction may be hazardous.
  • Severe myocardial damage or marked cardiac failure where magnesium-induced cardiovascular depression may be poorly tolerated.
  • Myasthenia gravis, because parenteral magnesium can exacerbate neuromuscular weakness.
  • Situations where intramuscular injection is contraindicated (for example, in patients with significant bleeding disorders or anticoagulation), for the IM route specifically.

Adverse Effects

  • Flushing, feeling of warmth, sweating and hypotension related to vasodilation, particularly with rapid intravenous administration.
  • Nausea, vomiting and gastrointestinal discomfort.
  • Injection-site pain, especially with intramuscular administration of undiluted solution.
  • Drowsiness, lethargy, confusion, dizziness and slurred speech at higher serum magnesium levels.
  • Loss or reduction of deep tendon reflexes indicating early magnesium toxicity.
  • Muscle weakness and, in severe cases, respiratory depression or apnoea.
  • Bradycardia, ECG changes, arrhythmias and, in extreme overdose, cardiac arrest.
  • Electrolyte disturbances, including effects on calcium levels.
  • Coma and profound central nervous system depression in cases of severe magnesium intoxication.
  • Hypersensitivity reactions, including rash or pruritus, though these are uncommon.

Storage Conditions

  • Keep out of the sight and reach of children.
  • Store in accordance with the product label, typically not above 25°C unless otherwise specified by the manufacturer.
  • Do not freeze.
  • Keep vials in the outer carton to protect from light until ready for use.
  • Do not use if the solution is not clear and colourless or if particulate matter is visible.
  • Do not use after the expiry date stated on the vial and outer packaging.
  • For single use only; discard any unused solution immediately after opening and preparation.

Duration

Treatment duration is determined by the prescribing physician according to the indication and clinical response. In most cases, magnesium sulphate is used as a short-term intervention for acute correction of hypomagnesaemia, peripartum seizure control in pre-eclampsia/eclampsia, management of acute severe asthma, or short-course therapy for arrhythmias, with dosing adjusted based on ongoing monitoring.

Onset

Onset of effect is typically rapid following appropriate intravenous administration, with therapeutic serum magnesium levels usually reached within minutes; intramuscular administration results in a slower onset, generally within approximately 30\u201360 minutes, depending on dose and patient factors.

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