ADCO MAGNESIUM SULPHATE 50 % is an injection that contains magnesium sulphate heptahydrate. It is used in the treatment of hypomagnesaemia and magnesium deficiency tetany.
1. What ADCO MAGNESIUM SULPHATE 50 % is and what it is used for.
2. What you need to know before you take/use ADCO MAGNESIUM SULPHATE 50 %.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Patients with impaired renal function (can produce toxic blood levels), severe renal impairment (glomerular filtration rate < 25 mL/h), renal failure, anuria
- Patients with intracranial pathology
- Children with intestinal parasitic diseases
- Hepatic encephalopathy, hepatic failure
- Patients with heart block (class I - III) or myocardial damage and myasthenia gravis
Special warnings and precautions for use
If administered intravenously, it must be given slowly. ADCO MAGNESIUM SULPHATE 50 % should not be used in hepatic coma if there is a risk of renal failure. Serum calcium levels and serum magnesium levels should be routinely monitored in patients receiving ADCO MAGNESIUM SULPHATE 50 %. The absence of respiratory depression should be monitored: the breath rate should not be under 16 breaths/min. The excretion of urine should not be under 25 mL/h, as it could lead to hypermagnesaemia. The presence of the patellar reflex should be checked. ADCO MAGNESIUM SULPHATE 50 % should be administered with caution if flushing and sweating occurs. An antidote of injectable calcium gluconate solution should be immediately available. ADCO MAGNESIUM SULPHATE 50 % should not be administered into muscles which are emaciated or atrophied. For intramuscular administration, the dorsogluteal muscle and sciatic nerve should be avoided. If the total dose to be administered exceeds 5 mL, the injection volume should be divided between more than one deep muscular injection site. Use caution in older or thin patients who may only tolerate up to 2 mL in a single injection. Do not use an injection site that has evidence of infection or injury. If repeating an intramuscular dose, rotate injection sites to avoid injury or discomfort to the muscles.
3. How to take/use ADCO MAGNESIUM SULPHATE 50 %.
In the treatment of magnesium deficiency tetany, 2 to 4 mL of the 50 % solution every 4 hours is recommended. It can be administered either intramuscularly or intravenously. Intravenously 1 to 4 g may be given as a 10 or 20 % solution at a rate not exceeding 150 mg per minute. It may also be given by infusion. The blood pressure should be monitored during each injection.
4. Possible side effects.
Undesirable effects
Excessive administration of ADCO MAGNESIUM SULPHATE 50 % may lead to the development of symptoms of hypermagnesaemia which may include the adverse reactions listed in the table below.
Tabulated list of adverse reactions
| System organ class | Frequency | Adverse reaction |
|---|---|---|
| Immune system disorders | Frequency unknown | Hypersensitivity reactions |
| Metabolism and nutrition disorders | Frequency unknown | Electrolyte/fluid abnormalities (hypophosphataemia, hypertonic dehydration) |
| Nervous system disorders | Frequency unknown | Respiratory depression, nausea, vomiting, drowsiness, confusion, coma, slurred speech, double vision, loss of tendon reflexes due to neuromuscular blockade |
| Cardiac disorders | Frequency unknown | Cardiac arrhythmias, cardiac arrest, ECG abnormal (prolonged PR, QRS and QT intervals), bradycardia |
| Vascular disorders | Frequency unknown | Flushing of the skin and hypotension due to peripheral vasodilatation |
| Musculoskeletal and connective tissue disorders | Frequency unknown | Muscle weakness |
| General disorders and administration site conditions | Frequency unknown | Thirst |
5. How to store ADCO MAGNESIUM SULPHATE 50 %.
Store at or below 25 °C.