Molecular mass: 117.146 g/mol PubChem compound: 247
Betaine interacts in the following cases:
Uncommon cases of severe cerebral oedema associated with hypermethioninemia were reported with betaine anhydrous therapy in patients with CBS deficiency. Complete recovery was seen after treatment discontinuation:
The plasma methionine concentrations should be kept below 1000 µM. It is recommended to measure plasma methionine level at start of treatment and about annually or biannually thereafter. If methionine increases particularly above the first safety threshold of 700 µmol/L, patient should be monitored more frequently and compliance with diet should be checked. In order to reduce methionine levels, modification of diet as well as dose reduction of betaine or temporal interruption of betaine treatment should be considered.
If any symptoms of cerebral oedema like morning headaches with vomiting and/or visual changes appear, plasma methionine level and compliance to the diet should be checked and treatment with betaine interrupted.
If symptoms of cerebral oedema recur after re-introduction of treatment then betaine anhydrous therapy should be discontinued indefinitely.
To minimise the risk of potential drug interactions, it is advisable to leave 30 minutes between the intake of betaine anhydrous and amino acids mixtures and/or medicinal products containing vigabatrin and GABA analogues.
Data on a limited number of exposed pregnancies indicate no adverse event of betaine on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiologic data are available. Animal reproduction studies have not been conducted. During pregnancy, administering betaine in addition to pyridoxine, folate, anticoagulant and diet under close monitoring of plasma homocysteine would be compatible with good maternal and foetal outcomes. However, betaine should not be used during pregnancy unless clearly necessary.
It is not known whether betaine anhydrous is excreted in human milk (although its metabolic precursor, choline, occurs at high levels in human milk). Because of lack of data, caution should be exercised when prescribing betaine to breast-feeding women.
No data is available.
Betaine has no or negligible influence on the ability to drive and use machines.
In general, adverse reactions seen with betaine anhydrous therapy appeared to be not serious and are mainly related to the gastrointestinal system. Gastrointestinal disorders like diarrhoea, glossitis, nausea, stomach discomfort, vomiting and dental disorders may occur uncommonly. The most commonly reported adverse reaction during treatment is blood methionine increased. Complete recovery was seen after treatment discontinuation.
Reported adverse reactions are listed below, by system organ class and by frequency.
Frequencies are defined as: 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Uncommon: anorexia
Uncommon: agitation, irritability
Uncommon: brain oedema*
Uncommon: diarrhoea, glossitis, nausea, stomach discomfort, vomiting
Uncommon: hair loss, hives, skin odour abnormal
Uncommon: urinary incontinence
* Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks to 6 months of starting betaine anhydrous therapy in patients with CBS deficiency, with complete recovery after treatment discontinuation.
Symptoms of cerebral oedema include morning headaches with vomiting and/or visual changes
High increases in plasma methionine levels in a range from 1,000 to 3,000 µM were noted in these patients. As cerebral oedema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to betaine anhydrous therapy has been postulated as a possible mechanism of action.
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