Betaine


Generic Medicine Info
Indications and Dosage
Oral
Adjunct in homocystinuria treatment
Adult: In patients with deficiencies or defects in cystathionine β-synthase (CBS), cobalamin cofactor metabolism (CBL), and 5,10-methylenetetrahydrofolate reductase (MTHFR): As betaine anhydrous oral powder: Usual dose: 3 g bid; may gradually increase until plasma homocysteine level is undetectable or present only in small amounts. Max: 20 g daily. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: <3 years As betaine anhydrous oral powder: Initially, 50 mg/kg bid, may increase at weekly intervals in increments of 50 mg/kg daily until plasma homocysteine level is undetectable or present only in small amounts; ≥3 years Same as adult dose. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Reconstitution
Mix the powder in 120-180 mL of water, juice, milk or formula until completely dissolved, or mix with food.
Special Precautions
Patient with CBS deficiency. Various preparations of betaine are available which are not to be used interchangeably; refer to specific product guidelines for detailed information. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Severe cerebral oedema associated with hypermethioninaemia (particularly in patients with CBS deficiency).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, glossitis, stomach discomfort, dental disorders.
Metabolism and nutrition disorders: Anorexia.
Psychiatric disorders: Irritability, agitation, depression, personality disorder, sleep disorder.
Renal and urinary disorders: Urinary incontinence.
Skin and subcutaneous tissue disorders: Hives, abnormal skin odour, hair loss.
Monitoring Parameters
Monitor total plasma homocysteine level (to determine patient response); plasma methionine at baseline and periodically thereafter in patients with CBS deficiency (maintain <1,000 micromol/L).
Action
Description: Betaine, an endogenous metabolite of choline, acts as a methyl group donor in the remethylation of homocysteine to methionine, thereby decreasing elevated homocysteine plasma concentrations in patients with homocystinuria.
Synonym: trimethylglycine.
Pharmacokinetics:
Absorption: Rapidly absorbed. Time to peak plasma concentration: 0.9 ± 0.3 hours.
Distribution: Rapidly distributed. Volume of distribution: 1.3 L/kg.
Excretion: Elimination half-life: 14 hours.
Chemical Structure

Chemical Structure Image
Betaine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 247, Betaine. https://pubchem.ncbi.nlm.nih.gov/compound/Betaine. Accessed Apr. 27, 2022.

Storage
Store between 15-30°C. Protect from moisture.
MIMS Class
Other Agents Affecting Metabolism
ATC Classification
A16AA06 - betaine ; Belongs to the class of amino acids and derivatives products. Used in treatment of alimentary tract and metabolism problems.
References
Anon. Betaine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 18/04/2022.

Anon. Betaine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/03/2022.

Betaine Anhydrous for Oral Solution (Oakrum Pharma, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/03/2022.

Buckingham R (ed). Betaine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/03/2022.

Cystadane 1 g Oral Powder (Recordati Rare Diseases). MHRA. https://products.mhra.gov.uk. Accessed 23/03/2022.

Joint Formulary Committee. Betaine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/03/2022.

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Cystadane 1 g Powder for Oral Administration data sheet June 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 23/03/2022.

Disclaimer: This information is independently developed by MIMS based on Betaine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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