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MAGNESIUM SULFATE INJECTION BP 20%W/V

Active substance(s): MAGNESIUM SULFATE / MAGNESIUM SULFATE

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Package leaflet: Information for the User

Elderly
No special recommendation except in patients with
kidney problems

Magnesium Sulfate20%w/v Solution for Injection
Magnesium Sulfate Heptahydrate

What is in this leaflet:
1. What Magnesium Sulfate Injection is and what it is
used for
2. What you need to know before you are given
Magnesium Sulfate Injection
3. How Magnesium Sulfate Injection will be given
4. Possible side effects
5. How to store Magnesium Sulfate Injection
6. Contents of the pack and other information

1. What Magnesium Sulfate Injection is
and what it is used for

Medicines which may interact with Magnesium Sulfate
Injection include:
· Digitalis glycosides e.g. digoxin (a medicine used to
treat heart problems)
· Barbiturates (e.g. amobarbital)
· Opioids ( e.g. morphine)
· Hypnotics ( e.g. nitrazepam)
· muscle relaxants e.g. tubocurarine
· Calcium channel blockers e.g. nifedipine or
nimodipine (medicines used to treat high blood
pressure) which could result in calcium ion
imbalance causing abnormal muscle function.
· Aminoglycoside antibacterials (such as
Streptomycin)
Pregnancy, fertility and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
It is not advisable to administer magnesium sulfate
during pregnancy or breastfeeding unless considered
essential, and it must be administered under medical
supervision. If used in pregnant women, the baby’s
heart rate will be monitored and will not be used
within 2 hours of delivery.

Driving and using machines
Magnesium Sulfate Injection is used to treat low levels There are no known effects of Magnesium Sulfate
of magnesium in the blood where it is not possible for Injection on driving and using machines.
the medicine to be taken by mouth.
It may also be used to prevent seizures (fits) caused
by a serious complication of pregnancy known as
eclampsia.

3. How Magnesium Sulfate Injection will
be given

Your doctor will give Magnesium Sulfate Injection
It is used in the treatment of acute hypomagnesaemia. to you into a vein (intravenous) or muscle either by
injection or infusion (drip).

2.What you need to know before you are
given Magnesium Sulfate Injection
You must not be given Magnesium Sulfate
Injection if:
· you are allergic to Magnesium Sulfate, its salts or
any of the other ingredients of this medicine listed
in section 6.
· you suffer from severe kidney failure
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before
receiving Magnesium Sulfate if you:
· suffer from any kidney problem.
· suffer from severe liver problems
· suffer from a disease of the muscles causing
drooping eyelids, double vision, difficulty in
speaking and swallowing and sometimes muscle
weakness in the arms or legs known as myasthenia
gravis
During treatment
Your blood calcium levels will be routinely monitored
whilst taking Magnesium Sulfate

Adults
For the treatment of low magnesium levels:
Up to 160 mmols of magnesium ions (200ml of a 20%
solution) by slow intravenous infusion (in glucose 5%)
over a period of up to 5 days.
To prevent fits associated with eclampsia:
An initial dose of 4g/20ml or 16 mmol/20ml of
magnesium ions intravenously (20ml of a 20%
solution) or in some cases 5g/25ml or 20 mmol/25ml
intravenously, as described above, is followed by an
infusion of 1g per hour continued for 24h after the
last fit.
If fits recur, a further 2-4g/10-20ml or 8-16 mmo/1020ml of magnesium ions (depending on your weight,
2g if you are less than 70Kg) is given intravenously
over 5 min.
Renal Failure:
Doses must be reduced in renal failure. Caution must
be observed to prevent exceeding the renal excretory
capacity. The dosage should not exceed 20g in
48 hours (100ml of a 20% solution or 80mmol of
magnesium ions).

Other medicines and Magnesium Sulfate Injection
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.

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100mm Measurement Verification Bar

Use in children and adolescents
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Read all of this leaflet carefully before you are
given this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist, or nurse
• If you get any of the side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
• In this leaflet, Magnesium Sulfate 20% w/v Solution
for Injection will be called Magnesium Sulfate
Injection.

For the treatment of low magnesium levels:
The usual dose is 100mg/kg (0.5ml/kg of 20% solution
or 0.4mmols/kg of magnesium ions) as a single dose,
repeated every 6 - 12 hours as necessary.

To prevent fits associated with low magnesium
levels:
The usual dose is 20-40mg/kg (0.1-0.2ml/kg of a 20%
solution or 0.08-0.16 mmols/kg of magnesium ions)
repeated every 4-6 hours as necessary.
Patients with kidney failure will be given a reduced
dose. The dose will not be more than 20g in 48 hours
(100ml of a 20% solution or 80mmols of magnesium
ions).
Renal impairment
Doses should be reduced in patients with kidney
problems

If you are given too much or too little of
Magnesium Sulfate Injection
As this medicine will be given to you whilst you are in
hospital, it is unlikely that you will be given too much
or too little, however, tell your doctor if you have any
concerns.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Contact your doctor or nurse immediately if you
get any of the following:
· Allergic reactions such as shortness of breath,
wheezing or difficulty breathing; swelling of the
face, lips, tongue or other parts of the body;
rash, itching or hives on the skin.
· High blood sugars causing severe dehydration
(Hyperosmolar dehydration)
Other side effects:
· feeling or being sick
· flushing of the skin
· feeling thirsty
· slowed reflexes
· temporarily low blood pressure
· drowsiness
· confusion
· muscle weakness
· slowed breathing
· low body temperature
· irregular or slow heartbeat
· heart attack
· coma
· low calcium levels in the blood (Hypocalcaemia)
· low phosphate levels in the blood
(Hypophosphataemia)
· double vision
· slurred speech

Reporting of side effects
If you or your child gets any side effects, talk to your
doctor, pharmacist or nurse. 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
Injection
Keep this medicine out of the sight and reach of
children. This Magnesium Sulfate Injection should not
be used after the expiry date which is printed on the
carton and ampoule label. The doctor or nurse will
check that the expiry date on the label has not been
passed before administering the injection to you.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater
. Ask your pharmacist how
to throw away medicines you no longer use. These
measures will help protect the environment.
Protect from light. Keep in outer carton.

6. Contents of the pack and other
Information
What Magnesium Sulfate Injection contains
The active substance is Magnesium Sulfate
Heptahydrate 20%w/v.
The other ingredients are water for injections, dilute
hydrochloric acid and sodium hydroxide.
What Magnesium Sulfate Injection looks like and
contents of the pack
Magnesium Sulfate Injection is a clear, colourless
solution supplied in 20ml ampoules.
Marketing Authorisation Holder
Aurum Pharmaceuticals Ltd
T/A Martindale Pharma
Bampton Road
Harold Hill
Romford RM3 8UG
England
Manufacturers
Macarthys Laboratories Ltd
T/A Martindale Pharma
Bampton Road
Harold Hill
Romford RM3 8UG
United Kingdom
Product Licence No: PL 12064/0048
This leaflet was last revised in: February 2017

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DEVELOPMENT ARTWORK
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PIL MAGNESIUM SULFATE 20%
W/V
170 x 296mm

18/03/16

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29/03/16

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01/08/16

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02/08/16

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03/08/16

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02/03/17

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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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