MAGNESIUM SULFATE 20% w/v Solution for infusion Ref.[6959] Active ingredients: Magnesium sulfate

Posology

Dosage should be tailored according to the individual patient’s needs and responses. Plasma magnesium concentrations should be measured to determine the rate and duration of infusion and should be monitored throughout therapy.

Treatment of magnesium deficiency in hypomagnesaemia

Up to 40 g or 160 mmols of magnesium ions (200ml of a 20% solution) by slow intravenous infusion (in glucose 5%) over up to 5 days, may be required to replace the deficit (allowing for urinary losses).

Elderly

No special recommendation. Use with caution due to risk of renal impairment in this age group, see below.

Renal impairment

Doses must be reduced in renal impairment. 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 80mmols of magnesium ions).

Prevention of recurrent seizures in eclampsia

A loading dose of 4g (16 mmols) of magnesium ions IV (20ml of a 20% solution) or in some cases 5g (20 mmols) og magnesium ions IV (25 ml of a 20% solution), given over 5-15 minutes, is followed by an infusion of 1g (4mmols)/h (5ml of a 20% solution) continued for 24h after the last fit.

Recurrent Convulsions: If convulsions recur, a further 2-4g (8-16 mmols) of magnesium ions (10-20 ml of a 20% solution,depending on the woman’s weight, 2g (8 mmols) if less than 70Kg) is given IV over 5 min.

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 (80 mmols of magnesium ions) over 48 hours.

For instructions on dilution of the product before administration, see section 6.6.

Paediatric population

No special recommendation.

Method of administration

Intravenous infusion.

Signs

Clinical signs of overdosage will be those of hypermagnesaemia, see section 4.8.

Treatment

Appropriate action should be taken to reduce the blood level of magnesium. Neuromuscular blockade associated with hypermagnesaemia may be reversed with calcium salts, such as calcium gluconate, which should be administered intravenously in a dose equivalent to 2.5 to 5mmol of calcium.

3 years.

This medicinal product does not require any special storage conditions.

The product must be used immediately after the opening of the container and the storage of opened ampoules should be avoided.

Transparent and colourless 10 ml glass ampoule type I. The ampoules are inserted into polypropylene blisters and packed in carton boxes. Each carton box contains 10 ampoules.

Magnesium sulfate can be diluted with Glucose 5% and Sodium chloride 0.9% solutions.

Disposal: No special requirements.