Methylating AgentPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Betaine Anhydrous
BETAINE ANHYDROUS
1. INDICATIONS AND USAGE Betaine Anhydrous for Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: • Cystathionine beta-synthase (CBS) deficiency • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency • Cobalamin cofactor metabolism (cbl) defect Betaine Anhydrous for Oral Solution is a methylating agent indicated in pediatric and adult pati...
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:Betaine Anhydrous
Quick Reference
Medicine ClassMethylating Agent
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- BETAINE ANHYDROUS
- Medicine class
- Methylating Agent
- Brand names
- Betaine Anhydrous
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- FDA approved
- Yes
What Is Betaine Anhydrous?
1. INDICATIONS AND USAGE Betaine Anhydrous for Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: • Cystathionine beta-synthase (CBS) deficiency • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency • Cobalamin cofactor metabolism (cbl) defect Betaine Anhydrous for Oral Solution is a methylating agent indicated in pediatric and adult pati...
Betaine Anhydrous (BETAINE ANHYDROUS) belongs to the Methylating Agent class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Betaine Anhydrous. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Betaine Anhydrous with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Betaine Anhydrous is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
INDICATIONS AND USAGE Betaine Anhydrous for Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients.
Included within the category of homocystinuria are: • Cystathionine beta-synthase (CBS) deficiency • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency • Cobalamin cofactor metabolism (cbl) defect Betaine Anhydrous for Oral Solution is a methylating agent indicated in pediatric and adult patients for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations.
Included within the category of homocystinuria are: • Cystathionine beta-synthase (CBS) deficiency • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency • Cobalamin cofactor metabolism (cbl) defect
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2. DOSAGE AND ADMINISTRATION Adults and Pediatric Patients 3 Years of Age and Older • The recommended dosage is 6 grams per day, administered orally in divided doses of 3 grams twice daily. (2.1) Pediatric Patients Less than 3 Years of Age • The recommended starting dosage is 100 mg/kg/day, administered orally in divided doses of 50 mg/kg twice daily, and then increased weekly by 50 mg/kg increments. (2.1) • Monitor patient response by plasma homocysteine concentrations. (2.1) • Increase the dosage gradually until the plasma total homocysteine concentration is undetectable or present only in small amounts. (2.1) Preparation and Administration Instructions • Prescribed amount of Betaine Anhydrous for Oral Solution should be measured with the measuring scoop provided and then dissolved in 4 to 6 ounces of water, juice, milk, or formula until completely dissolved, or mixed with food for immediate ingestion. (2.2) 2.1 Dosage Therapy with Betaine Anhydrous for Oral Solution should be direct
Available Forms
Available Strengths
Side Effects
Common
- ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: • Hypermethioninemia and cerebral edema in patients with CBS deficiency [see Warnings and Precautions (5.1)] .
- Most common adverse reactions (> 2%) are: nausea and gastrointestinal distress, based on physician survey (6.1).
- To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc.
- at 1-855-224-0233 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
- See 17 for PATIENT COUNSELING INFORMATION.
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- The assessment of clinical adverse reactions is based on a survey study of 41 physicians, who treated a total of 111 homocystinuria patients with Betaine Anhydrous for Oral Solution.
Serious
- WARNINGS AND PRECAUTIONS 5.1 Hypermethioninemia in Patients with CBS Deficiency Patients with homocystinuria due to cystathionine beta-synthase (CBS) deficiency may also have elevated plasma methionine concentrations.
- Treatment with Betaine Anhydrous for Oral Solution may further increase methionine concentrations due to the remethylation of homocysteine to methionine.
- Cerebral edema has been reported in patients with hypermethioninemia, including patients treated with Betaine Anhydrous for Oral Solution [see Adverse Reactions (6.2)] .
- Monitor plasma methionine concentrations in patients with CBS deficiency.
- Plasma methionine concentrations should be kept below 1,000 micromol/L through dietary modification and, if necessary, a reduction of Betaine Anhydrous for Oral Solution dosage.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5. WARNINGS AND PRECAUTIONS 5.1 Hypermethioninemia in Patients with CBS Deficiency Patients with homocystinuria due to cystathionine beta-synthase (CBS) deficiency may also have elevated plasma methionine concentrations. Treatment with Betaine Anhydrous for Oral Solution may further increase methionine concentrations due to the remethylation of homocysteine to methionine. Cerebral edema has been r
How Betaine Anhydrous Works
Pharmacokinetics
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Betaine Anhydrouswhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
Related on MedCentralHub
- Class hub
Methylating Agent alternatives
Compare all Methylating Agent medications — uses, side effects, and cost differences
- Detail
Betaine Anhydrous dosage guide
Adult, pediatric, renal, and hepatic dosing for Betaine Anhydrous
- Detail
Betaine Anhydrous side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Betaine Anhydrous
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.