Magnesium sulfate 50% (magnesium 2mmol/ml) solution for injection 10ml ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Magnesium sulfate heptahydrate

Available from:

magnesium 2mmol/ml) solution for injection 10ml ampoules (Martindale Pharmaceuticals Ltd

ATC code:

B05XA05

INN (International Name):

Magnesium sulfate heptahydrate

Dosage:

500mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09050103; GTIN: 5026468000265

Patient Information leaflet

00000
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
Magnesium Sulfate Injection is used to treat low levels
of magnesium in the blood where it is not possible for
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.
It is used in the treatment of acute hypomagnesaemia.
2. WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN MAGNESIUM SULFATE
INJECTION
YOU SHOULD 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 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.
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.
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) w

Summary of Product characteristics

OBJECT 1
MAGNESIUM SULFATE 50%W/V SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 21-Feb-2018 | Martindale
Pharma
1. Name of the medicinal product
Magnesium Sulfate 50%w/v Solution for Injection
2. Qualitative and quantitative composition
Magnesium Sulfate Heptahydrate
5g/ 10ml
2.5g/ 5ml
1g/ 2ml
For full list of excipients, see section 6.1
3. Pharmaceutical form
Sterile Solution for Injection
A clear, colourless solution practically free from visible particles
4. Clinical particulars
4.1 Therapeutic indications
• Treatment of Magnesium deficiency where the oral route of
administration may be inappropriate..
• To prevent further seizures associated with eclampsia.
4.2 Posology and method of administration
Dosage should be individualised according to patient's needs and
responses.
Plasma levels should also be monitored throughout therapy.
_a) Treatment of magnesium deficiency in hypomagnesaemia:_
For intravenous administration, a concentration of 20% or less should
be used; the rate of injection not
exceeding 1.5ml/minute of a 10% solution or its equivalent.
Up to 40g MgSO
4
(equivalent to 160mmol Mg
2+
) by slow intravenous infusion (in glucose 5%) over up
to 5 days, may be required to replace the deficit (allowing for
urinary losses).
Mild magnesium deficiency
1g intramuscularly every 6 hours for 4 doses.
Severe magnesium deficiency
Up to 250mg/kg intramuscularly given within a period of 4 hours or
5g/litre of infusion solution
intravenously over 3 hours
Paedriatric population
It is recommended that the solution be diluted to 20% w/v prior to
intramuscular injection
Elderly
No special recommendation except in renal impairment, see below
Renal impairment:
Dosage should be reduced in renal impairment. Plasma magnesium
concentrations should be monitored
throughout therapy
_b) To prevent further seizures associated with eclampsia:_
An initial intravenous (IV) loading dose is followed for 24h by either
an IV infusion, or regular
intramuscular (IM) injections.
_INTRAMUSCULAR MAINTENANCE REGIMEN_
A