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Betaine

Class
Homocysteine-lowering agents
Subclass
Methylating agents
Substance name
Betaine anhydrous
Brand names
Cystadane®
Common formulations
Powder
Dosage and administration
Adults patients
Treatment of homocystinuria
•
3 g PO BID
Indications for use
Labeled indications
Adults
•
Treatment of homocystinuria
Children
•
Treatment of cystathionine β-synthase deficiency
•
Treatment of methylenetetrahydrofolate reductase deficiency
Safety risks
Contraindications
Known betaine hypersensitivity
•
Screen patients for any known allergies or hypersensitivity to the medication, and avoid its use in individuals with a history of anaphylaxis to Betaine or related substances.
Warnings and precautions
Cerebral edema
•
Use extreme caution with pre-existing hypermethioninemia. Prior to starting Betaine treatment, conduct regular neurological assessments, and monitor plasma methionine levels closely to prevent the development of cerebral edema. Immediately discontinue the medication, administer appropriate osmotic agents (e.g., mannitol), and seek neurologic consultation for prompt management and monitoring of cerebral edema.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Use only if clearly needed. Animal studies have not been conducted. There are no controlled data in human pregnancy.
•
Limited case and post marketing reports have not identified major birth defects, miscarriage, or other adverse outcomes for the fetus or mother.
Breastfeeding
Little information available on breastfeeding safety.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
Diarrhea, dyspepsia, nausea
Unknown frequency
•
AKI, agitation, carcinogenesis, cerebral edema, drug-induced liver injury, glossitis, hematologic disorders, abdominal pain, body odor, depression, emotional lability, insomnia, irritability, urinary incontinence, urticaria
Interactions
Drug(s)
Check Interactions
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