Magnesium aspartate

Diuretics (e.g. thiazide, furosemide) are widely used in the treatment of hypertension, heart failure and kidney diseases. They increase urinary output with hypermagnesuria probably leading to hypomagnesaemia and magnesium depletion. Because of increased magnesium losses, a dose adjustment of magnesium may be necessary when taking diuretics (such as thiazide and furosemide).

EGF-receptor antagonist (e.g. cetuximab, erlotinib) are used in the treatment of metastatic colorectal cancer. As EGF is a magnesiotropic hormone, treatment with EGF-receptor antagonists was related to severe hypomagnesaemia. Because of increased magnesium losses, a dose adjustment of magnesium may be necessary when taking EGF-receptor antagonist (e.g. cetuximab, erlotinib).

Because of increased magnesium losses, a dose adjustment of magnesium may be necessary when taking cisplatinum and ciclosporin A.

Aminoglycoside antibiotics (e.g. gentamycin, tobramycin) are widely used in the treatment of severe bacterial infections. Studies showed that in 25% of the patients, hypomagnesaemia occurs due to renal magnesium loss. Because of increased magnesium losses, a dose adjustment of magnesium may be necessary when taking aminoglycoside antibiotics (e.g. gentamycin, tobramycin).

Long-term treatment with proton pump inhibitors (e.g. omeprazole, pantoprazole) has been related to severe hypomagnesaemia, probably due to disturbances in absorption. Because of increased magnesium losses, a dose adjustment of magnesium may be necessary when taking proton pump inhibitors (e.g. omeprazole, pantoprazole).

A large amount of data on pregnant women over 16 weeks gestation (more than 1000 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of magnesium.

Magnesium can be used during pregnancy if clinically needed.

Administration of aminoglycoside antibiotics should be avoided during this period, as there are indications of interactions.

Magnesium can be used during breast-feeding.

Magnesium aspartate/metabolites are excreted in human milk, but at therapeutic doses of magnesium no effects on the breastfed newborns/infants are anticipated.

Fertility

Based on long-term experience, no effects of magnesium on male and female fertility are anticipated.

Magnesium has no or negligible influence on the ability to drive and use machines.

The evaluation of undesirable effects is based on the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Gastrointestinal disorders

Uncommon: Soft stools or diarrhoea following high dosage

General disorders and administration site conditions

Very rare: Fatigue if used long-term

At high dosage diarrhoea or gastrointestinal irritation may occur. If diarrhoea occurs, the daily dose should be reduced and gradually increased later if needed.

In cases of high doses and long-term use fatigue may be experienced. This may be an indication that an elevated magnesium level has been achieved. Hypermagnesemia is rare after oral administration of magnesium salts, unless there is renal dysfunction.