Magnesium Sulfate 50%w/v Solution for Injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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.

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

• 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.

Talk to your doctor, pharmacist or nurse before receiving Magnesium Sulfate if you:

• suffer from any kidney problem.
• suffer from 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.

Your blood calcium levels will be routinely monitored whilst taking Magnesium Sulfate.

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

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)

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. Tell your doctor if you are pregnant or trying to become pregnant. Magnesium Sulfate Injection will only be given to you if your doctor considers the benefit of treatment outweighs the risk to the developing baby. Low blood calcium levels and effects on the bones, such a reduced bone density, have been reported in babies whose mothers were given magnesium sulphate continuously for more than 5-7 days during pregnancy.

It is not advisable to administer magnesium sulfate during pregnancy or breast-feeding 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.

There are no known effects of Magnesium Sulfate Injection on driving and using machines. Please speak to your doctor before driving or operating machinery.

You will be given up to 40g by slow intravenous infusion (drip) (in glucose 5%) over a period of up to 5 days.

After an initial intravenous dose you will be monitored for 24 hours and then you may be given either an intravenous infusion (drip) or regular intramuscular injections.

Intramuscular Maintenance Regimen

A loading dose of 4g MgSO4 IV (usually in 20% solution) over 5min (minimum, preferably 10-15 min) is followed immediately by 5g MgSO4 (approx. 20mmol Mg2+) (usually in 50% solution) as a deep IM injection into the upper outer quadrant of each buttock.

Maintenance therapy is a further 5g MgSO4 IM every 4h, continued for 24h after the last fit (provided the respiratory rate is >16/min, urine output >25ml/h, and knee jerks are present).

Intravenous Maintenance Regimen

A loading dose of 4g MgSO4 IV (or in some cases 5g MgSO4 IV, as described above, is followed by an infusion of 1g/h continued for 24h after the last fit.

Recurrent Convulsions: In both the IM and IV regimens, if convulsions recur, a further 2-4g MgSO4 (depending on the woman’s weight, 2g MgSO4 if less than 70Kg is given IV 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).

No special recommendation except in patients with kidney problems.

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.

• 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).
• Heart attack (shortness of breath, chest pain, feeling faint and/or dizzy)
• coma

• feeling or being sick
• flushing of the skin
• feeling thirsty
• loss/slowed reflexes
• temporarily low blood pressure
• drowsiness
• confusion
• muscle weakness
• slowed breathing
• irregular or slow heartbeat
• Problems with the balance of salts and water in the blood. This may lead to thirst (which may be severe), dry mouth, tiredness, restlessness and muscle weakness. There have been isolated reports of low blood calcium levels in mothers and their new-born babies following prolonged use and high doses of magnesium sulphate during pregnancy.
• low phosphate levels in the blood (Hypophosphataemia)
• double vision
• slurred speech
• sweating
• dizziness
• headache
• pain and burning at the site of injection following IV/IM injection
• risk of itching and tingling
• rapid heartbeat

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is Magnesium Sulfate

Heptahydrate 2ml contains 1g Magnesium Sulfate Heptahydrate (4mmol Mg2+)

5ml contains 2.5g Magnesium Sulfate Heptahydrate (10mmol Mg2+)

10ml contains 5g Magnesium Sulfate Heptahydrate (20mmol Mg2+)

The other ingredients are water for injection, hydrochloric acid and sodium hydroxide.

Magnesium Sulfate sterile solution for injection/ concentrate for solution for infusion is a clear, solution supplied in 2ml, 5ml and 10ml glass ampoules.

10 ampoules are packed in each carton.

Not all pack sizes may be marketed.