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MAGNESIUM SULFATE 50% W/V SOLUTION FOR INJECTION OR INFUSION

Active substance(s): MAGNESIUM SULFATE

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Patient Information Leaflet
Magnesium Sulfate 50% w/v Solution for Injection or Infusion






Please read this leaflet carefully before you start using this medicine.
Keep this leaflet in a safe place, you may wish to read it again.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
If any side effect gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Magnesium Sulfate Solution for Injection or Infusion is and what it is
used for
2. Before you are given Magnesium Sulfate Solution for Injection or Infusion
3. How Magnesium Sulfate Solution for Injection or Infusion is used
4. Possible Side Effects
5. How to store Magnesium Sulfate Solution for Injection or Infusion
6. Further Information
1. What Magnesium Sulfate Solution for Injection or Infusion is and what it is used for
Magnesium Sulfate, the active ingredient, plays a number of important roles in the body, and
is involved in the regulation of the nervous and blood systems. This medicine is a solution
for injection or infusion and is used for magnesium deficiency and prevention (and control) of
seizures in patients with severe pre-eclampsia (high blood pressure associated with
pregnancy) or eclampsia (convulsions as a result of pre-eclampsia).
2. Before you are given Magnesium Sulfate Solution for Injection or Infusion
This medicine should NOT BE USED if you:
• Are allergic to magnesium or its salts
• Have suffered from a disease of the brain associated with cirrhosis of the liver
• Have had liver failure
• Have had kidney failure
• Have myasthenia gravis (a chronic progressive muscular weakness disease)
• Suffer from heart disease
Check with your doctor if you are concerned about any of the above.
This medicine should be used with caution in patients who are:
• Suffering from impaired kidney function
Taking other medicines:
Please tell your doctor if you are taking any other medication especially digitalis glycosides,
nifedipine, muscle relaxants or central nervous system depressants such as sedatives.
Check with your doctor if you are concerned about any of the above.
3. How Magnesium Sulfate Solution for Injection or Infusion is used
The doctor will decide what dose of this medicine you should be given. Check the label
carefully. If you are not sure about anything, ask your doctor, nurse or pharmacist.
The usual dose for the treatment of magnesium deficiency is:
Up to 160mmol of magnesium given by slow intravenous infusion (using concentrations not
higher than 20% w/v) over a maximum of 5 days. If further treatment is required, for example
during prolonged feeding by drip, the usual daily dose is about 12mmol of magnesium.
The usual dose for the prevention and control of fits associated with severe
pre-eclampsia and eclampsia is:
An initial intravenous dose of 4g, given slowly over a period of 20 minutes or so, is followed
by an infusion of 1g/hour. If necessary, regular injections of 5g can be made into the
buttocks every 4 hours, for at least 24 hours after the last fit. If fits recur a further 2 - 4g is
given intravenously over 5 minutes.
You may be given (prescribed) a different dose by your doctor if you have problems
with your kidneys.
If swallowed this medicine may cause stomach irritation and watery diarrhoea.
If any of this medicine is swallowed tell your doctor immediately.
If a dose of this medicine is not given at the correct time – the dose should be given as
soon as it is remembered. The next dose should be given at the usual time.
If more of this medicine is given than should be – tell your doctor as soon as possible. If
you are a medical practitioner administering this medicine an overdose may be reversed
with calcium salts which should be administered slowly intravenously in a dose equivalent to
2.5 to 5mmol of calcium (please refer to the Summary of Product Characteristics).


Additional information for Healthcare Professionals
(as stated on the Summary of Product Characteristics)
Therapeutic Indications
(a) Treatment of magnesium deficiency in hypomagnesaemia.
(b) Prevention and control of generalised seizures in patients with severe pre-eclampsia or
eclampsia.
Posology and Method of Administration
Dosages should be adjusted according to the patient's needs and responses. Plasma levels
should also be monitored during treatment.
(a) Treatment of magnesium deficiency in hypomagnesaemia:
Up to 160mmol Mg2+ by slow intravenous infusion (in glucose 5%) for up to 5 days, may be
required to replace the deficit (allowing for urinary losses). Concentrations of no higher than
20%w/v should be given intravenously.
Treatment may require repetition, for example during prolonged intravenous nutrition
magnesium deficiency can occur, then parenteral doses of magnesium are of the order of 10
to 20mmol Mg2+ daily (often about 12mmol Mg2+ daily).
Dosage for the elderly is similar to that for younger adults. Magnesium Sulfate 50% w/v
Solution for Injection or Infusion should not be given to children. Appropriate reductions in
dosage should be made for patients with renal impairment.

4. Possible side effects of Magnesium Sulfate Solution for Injection or Infusion
As with all medicines, there may be some side effects with this medicine.
The most common side effects are:• Respiratory depression (slow or shallow breathing) and abnormal heart beats
• Nausea (feeling sick) and/or vomiting
• Lowering of blood pressure
• Sweating and high temperature
• Thirst
• Confusion
• Drowsiness
• Muscle weakness
Very rare side effects are:
• Heart attack (shortness of breath, chest pain, feeling faint and/or dizzy)
• Coma
Tell your doctor, nurse or pharmacist immediately if you think you have any of these,
or other problems.
Reporting of Side Effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store Magnesium Sulfate Solution for Injection or Infusion
The medicine has an expiry date printed on the ampoule, vial and carton. Before use the
doctor or nurse will check the medicine has not passed this date and that the medicine does
not show any sign of deterioration. The expiry date refers to the last day of the month.
Only use this medicine if it is particle free.
After the expiry date, any unused medicine should be returned to a pharmacy.
Keep the container in the original outer carton.
Store between 2 - 25°C.
Store this medicine in a safe place where children cannot see or reach it.
6. Further information
What this medicine contains:
• The active ingredient is Magnesium Sulfate (500g per litre).
• It also contains the inactive ingredients Sulfuric Acid and Water for Injections.
What this medicine looks like and contents of the pack:
This medicine is a clear and colourless solution. This medicine is available in 2mL, 5mL and
10mL ampoules, and 20mL and 50mL vials. The medicine is packed into cartons containing
10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the same
time.
Marketing Authorisation Holder: Torbay and South Devon NHS Foundation Trust,
Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon, TQ4 7FG
Sites of Manufacture:
Torbay and South Devon NHS Foundation
Trust
Torbay Pharmaceuticals
Long Road
Paignton
Devon
TQ4 7TW

Torbay and South Devon NHS Foundation
Trust
Torbay Pharmaceuticals
Wilkins Drive
Paignton
Devon
TQ4 7FG

This leaflet was last revised in: 12/2015
PL 13079/0004
PIL/4/6


(b) Prevention and control of seizures associated with severe pre-eclampsia and
eclampsia:
An initial intravenous (IV) loading dose of typically 4g (approximately 16mmol Mg2+) given
slowly over a period of 20 minutes or so, at a strength no higher than 20% w/v, is followed
by ideally an IV infusion, or if this is not possible by regular intramuscular (IM) injections as
follows:
Intravenous Maintenance Regimen: The loading dose is followed by an intravenous
infusion of 1g (approximately 4mmol Mg2+) per hour, continued for 24 hours after the last fit.
Intramuscular Maintenance Regimen: The loading dose is followed by 5g (approximately
20mmol Mg2+), usually in 50% solution, as deep IM injection into the upper outer quadrant of
each buttock. The intramuscular injection is painful.
Maintenance therapy is a further 5g every 4 hours continued for 24 hours after the last fit
(provided the respiratory rate is >16 per minute, urine output >25mL per hour and knee jerks
are present).
Recurrent convulsions: In both the IV and IM regimens, if convulsions recur, a further 2 - 4g
(approximately 8 - 16mmol Mg2+), depending on the woman's weight, 2g if less than 70kg, is
given IV over 5 minutes.
Appropriate reductions in dosage should be made for patients with renal impairment: a
suggested dose reduction in severe renal impairment is a maximum of 20g (approximately
80mmol Mg2+) over 48 hours.
Incompatibilities
Not applicable.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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