MAGNESIUM SULFATE-AFT CONCENTRATE FOR SOLUTION FOR INJECTION 50% W/V [SIN17263P]

Product Info

MAGNESIUM SULFATE-AFT CONCENTRATE FOR SOLUTION FOR INJECTION 50% W/V

[SIN17263P]

Indication

4.1 THERAPEUTIC INDICATIONS

Parenteral administration of magnesium is indicated in the treatment of acute hypomagnesaemia.

Magnesium salts are also indicated to prevent hypomagnesaemia in patients receiving total parenteral nutrition.

Magnesium sulfate heptahydrate is also indicated in the prevention and treatment of lifethreatening seizures in the treatment of toxemias of pregnancy (pre-eclampsia and eclampsia).

Dosing

4.2 DOSE AND METHOD OF ADMINISTRATION

Magnesium sulfate heptahydrate is administered intravenously or intramuscularly.

Intravenous doses should be diluted to a concentration of 20% magnesium or less. For intravenous dosing, each 5 mL ampoule of Magnesium Sulfate-AFT injection should be diluted by adding at least 7.5 mL of a compatible solution (see Compatibilities).

For intramuscular dosing, a concentration of 25 to 50% is satisfactory for adults, while a concentration of 20% should be used for infants or children. For adult intramuscular administration, dilution of Magnesium Sulfate-AFT injection is not required, but each 5 mL ampoule could be diluted by adding up to 5 mL of a compatible solution.

The dose of magnesium should be adjusted according to the patients’ individual requirements and response.

The total adult daily dose should not exceed 30 to 40 g of magnesium sulfate heptahydrate per day.

Mild hypomagnesaemia: Adults: A dose of 1 g magnesium sulfate heptahydrate (8 mEq) intramuscularly every 6 hours for 4 doses is recommended.

Severe hypomagnesaemia: Adults: A dose of 0.25 g/kg magnesium sulfate heptahydrate intramuscularly over 4 hours is recommended. Alternatively a dose of 5 g may be given by slow intravenous infusion over 3 hours.

Total parenteral nutrition: Adults: A dose of 0.5 to 3.0 g magnesium sulfate heptahydrate (4 to 24 mEq) daily may be administered.

Infants: A dose of 0.25 to 1.25 g magnesium sulfate heptahydrate (2 to 10 mEq) daily may be administered.

Toxemia of pregnancy: An initial intravenous dose of 4 g magnesium sulfate heptahydrate is recommended. This is followed by an intramuscular dose of 4 to 5 g into each buttock. This may be followed by a dose of 4 to 5 g into alternate buttocks every four hours as needed.

Alternatively, the initial IV dose may be followed by an infusion of 1 to 2 g/h.

Compatibilities

Magnesium Sulfate Heptahydrate 50% Concentrated Injection is reported to be chemically stable and compatible with:

• Sodium chloride 0.9%

• Lactated Ringer's injection

• Glucose 5% in water

• Glucose 5% in sodium chloride 0.9%

The injection solution when diluted with the above-mentioned diluents in ratio 1:1.5 (drug product : diluent) is stable for 24 hours if stored under 25 °C. However, in order to reduce microbial contamination, the diluted solutions should be used immediately.

Contraindications

4.3 CONTRAINDICATIONS

Magnesium is contraindicated in patients with heart block, since magnesium may exacerbate this condition.

Magnesium is also contraindicated in patients with renal failure (creatinine clearance <20 mL/min), since there is an increased risk of hypermagnesaemia in these patients.

Magnesium sulfate heptahydrate should not be administered to pregnant women in the two hours prior to delivery, unless it is the only therapy available to prevent eclamptic seizures. There is a risk that the neonate will be born with hypermagnesaemia and depressed breathing.