Betaine


Concise Prescribing Info
Indications/Uses
Adjunct in homocystinuria treatment.
Dosage/Direction for Use
Adult : PO In patient w/ cystathionine beta-synthase (CBS) deficiency; 5,10-methylenetetrahydrofolate reductase deficiency; cobalamin co-factor metabolism defect: As powd for soln: Initial: 3 g bid, adjust dose according to plasma homocysteine concentration. Max: 20 g/day.
Dosage Details
Oral
Adjunct in homocystinuria treatment
Adult: In patient w/ cystathionine beta-synthase (CBS) deficiency; 5,10-methylenetetrahydrofolate reductase deficiency; cobalamin co-factor metabolism defect: As powd for soln: Initially, 3 g bid, adjust dose according to plasma homocysteine concentration. Max: 20 g daily.
Child: <10 yr As powd for soln: 100 mg/kg daily in 2 divided doses, may increase gradually according to patient’s response up to 150 mg/kg daily. ≥10 yr Same as adult dose.
Special Precautions
Patient w/ CBS deficiency.
Adverse Reactions
Significant: Hypermethioninaemia and severe cerebral oedema (CBS deficiency).
Nervous: Agitation, irritability, brain oedema, depression, personality disorder, sleep disturbances.
GI: Anorexia, diarrhoea, glossitis, nausea, stomach discomfort, vomiting, dental disorders, dysgeusia.
Genitourinary: Urinary incontinence.
Dermatologic: Hair loss, urticaria, abnormal skin odour.
MonitoringParameters
Monitor total plasma homocysteine level to determine response. Monitor methionine serum level prior to therapy and periodically thereafter in patient w/ CBS and maintain at <1,000 mmol/L.
Action
Description: Betaine is a methyl group donor that functions in the normal metabolic cycle of methionine. It is used to remethylate homocysteine to methionine, thereby decreasing homocysteine plasma concentration in patient w/ homocystinuria.
Pharmacokinetics:
Absorption: Rapidly absorbed. Time to peak plasma concentration: 0.9 ± 0.3 hr.
Distribution: Rapidly distributed. Volume of distribution: 1.3 L/kg.
Excretion: Via urine (4%). Elimination half-life: 14 hr.
Storage
Store between 15-30°C. Protect from moisture.
ATC Classification
A16AA06 - betaine ; Belongs to the class of amino acids and derivatives products. Used in treatment of alimentary tract and metabolism problems.
References
Schwahn B, Hafner D, Hohlfeld T et al. Pharmacokinetics of oral betaine in healthy subjects and patients with homocystinuria. Aug 22, 2002. British Journal of Clinical Pharmacology. 2003:6-13. doi: 10.1046/j.1365-2125.2003.01717.x. Accessed 03/08/2017

Anon. Betaine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/08/2017.

Buckingham R (ed). Betaine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/08/2017.

Crystadane Powder For Soln (Orphan Europe SARL). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/08/2017.

Joint Formulary Committee. Betaine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/08/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Betaine. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 02/08/2017.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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