Drug Guide
Betaine
Classification
Therapeutic: Nutritional supplement, used in homocystinuria and methylation support
Pharmacological: Methyl donor agent
FDA Approved Indications
- Homocystinuria due to cystathionine beta-synthase deficiency
- Methylation support in folate-sensitive neural tube defects
Mechanism of Action
Betaine acts as a methyl donor, converting homocysteine to methionine via the enzyme betaine-homocysteine methyltransferase, thus reducing homocysteine levels.
Dosage and Administration
Adult: As directed by a healthcare professional, typically 6 grams daily in divided doses for homocystinuria.
Pediatric: Dosage varies; should be determined by a healthcare provider based on age and condition.
Geriatric: No specific adjustments, but caution advised due to renal or hepatic function.
Renal Impairment: Use caution; dose adjustments may be necessary according to renal function.
Hepatic Impairment: Use with caution; consult healthcare provider for specific guidance.
Pharmacokinetics
Absorption: Well absorbed orally.
Distribution: Distributed widely in tissues.
Metabolism: Primarily metabolized in the liver.
Excretion: Excreted in urine.
Half Life: Approximately 1.5 to 2 hours.
Contraindications
- Known hypersensitivity to betaine or any component of the formulation
Precautions
- Use with caution in patients with renal or hepatic impairment, intestinal obstruction, or dehydration. Monitor homocysteine levels and renal function regularly.
Adverse Reactions - Common
- Gastrointestinal upset (nausea, diarrhea) (Common)
- Odor or taste disturbance (Uncommon)
Adverse Reactions - Serious
- Elevated serum sodium levels (hypernatremia) (Rare)
- Allergic reactions, including rash, pruritus, or bronchospasm (Rare)
Drug-Drug Interactions
- Divided doses of betaine may interfere with certain enzymes or metabolic pathways—consult healthcare provider for specific interactions.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor homocysteine levels, renal and hepatic function, and electrolyte status periodically.
Diagnoses:
- Risk for electrolyte imbalance
- Impaired nutritional status
Implementation: Administer as prescribed, typically orally with meals to reduce gastrointestinal distress. Educate the patient about dietary considerations.
Evaluation: Assess reduction in homocysteine levels and clinical improvement.
Patient/Family Teaching
- Take medication as prescribed, with meals if tolerated.
- Report any allergic reactions, gastrointestinal symptoms, or unusual side effects.
- Maintain hydration and follow dietary advice provided by your healthcare provider.
Special Considerations
Black Box Warnings: N/A
Genetic Factors: N/A
Lab Test Interference: Possible interference with serum folate and vitamin B12 assays.
Overdose Management
Signs/Symptoms: Hypernatremia, gastrointestinal upset, headache.
Treatment: Discontinue medication, symptomatic treatment, and supportive care as needed; initiate hydration and correct electrolyte imbalances.
Storage and Handling
Storage: Store at room temperature, away from moisture and heat.
Stability: Stable under recommended storage conditions for the duration of the shelf life.