- Approval Id
- 2ae7d88216eef9c3
- Drug Name
- MAGNESIUM SULFATE-AFT CONCENTRATE FOR SOLUTION FOR INJECTION 50% W/V
- Product Name
- MAGNESIUM SULFATE-AFT CONCENTRATE FOR SOLUTION FOR INJECTION 50% W/V
- Approval Number
- SIN17263P
- Approval Date
- 2025-06-19
- Registrant
- APEX PHARMA MARKETING PTE. LTD.
- Licence Holder
- APEX PHARMA MARKETING PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Dosage
- <p><strong>4.2 DOSE AND METHOD OF ADMINISTRATION</strong></p>
<p>Magnesium sulfate heptahydrate is administered intravenously or intramuscularly.</p>
<p>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).</p>
<p>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.</p>
<p>The dose of magnesium should be adjusted according to the patients’ individual requirements and response.</p>
<p>The total adult daily dose should not exceed 30 to 40 g of magnesium sulfate heptahydrate per day.</p>
<p><strong>Mild hypomagnesaemia</strong>: Adults: A dose of 1 g magnesium sulfate heptahydrate (8 mEq) intramuscularly every 6 hours for 4 doses is recommended.</p>
<p><strong>Severe hypomagnesaemia:</strong> 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.</p>
<p><strong>Total parenteral nutrition:</strong> Adults: A dose of 0.5 to 3.0 g magnesium sulfate heptahydrate (4 to 24 mEq) daily may be administered.</p>
<p><em><strong>Infants:</strong></em> A dose of 0.25 to 1.25 g magnesium sulfate heptahydrate (2 to 10 mEq) daily may be administered.</p>
<p><strong>Toxemia of pregnancy:</strong> 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.</p>
<p>Alternatively, the initial IV dose may be followed by an infusion of 1 to 2 g/h.</p>
<p><strong>Compatibilities</strong></p>
<p>Magnesium Sulfate Heptahydrate 50% Concentrated Injection is reported to be chemically stable and compatible with:</p>
<ul>
<li>Sodium chloride 0.9%</li>
<li>Lactated Ringer's injection</li>
<li>Glucose 5% in water</li>
<li>Glucose 5% in sodium chloride 0.9%</li>
</ul>
<p>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.</p>
- Route Of Administration
- INTRAVENOUS, INTRAMUSCULAR
- Indication Info
- <p><strong>4.1 THERAPEUTIC INDICATIONS</strong></p>
<p>Parenteral administration of magnesium is indicated in the treatment of acute hypomagnesaemia.</p>
<p>Magnesium salts are also indicated to prevent hypomagnesaemia in patients receiving total parenteral nutrition.</p>
<p>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).</p>
- Contraindications
- <p><strong>4.3 CONTRAINDICATIONS</strong></p>
<p>Magnesium is contraindicated in patients with heart block, since magnesium may exacerbate this condition.</p>
<p>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.</p>
<p>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.</p>
