Dosing & Uses
Dosage Forms & Strengths
anhydrous powder for oral solution
- 180g/bottle
Homocystinuria
6 g/day PO divided q12hr
Titrate dose until plasma homocysteine concentration is undetectable or extremely low
Up to 20 g/day has been used
Administration
One level scoopful (provided by manufacturer) is 1 g
Dissolve required amount in 120-180 mL water, milk or juice and ingest mixture immediately
Do not take if not fully dissolved or colored
Dosage Forms & Strengths
anhydrous powder for oral solution
- 180g/bottle
Homocystinuria
<3 years: 100 mg/kg/day PO increase weekly by 100 mg/kg until plasma homocysteine is undetectable or present only in small amounts
≥3 years: 6 g/day PO divided q12hr; titrate dose until plasma homocysteine concentration is undetectable or extremely low; up to 20 g/day has been used
Administration
One level scoopful (provided by manufacturer); one level 1.7 mL scoop is equal to 1 g of betaine anhydrous powder
Dissolve required amount in 120-180 mL water, milk or juice and ingest mixture immediately
Do not take if not fully dissolved or colored
Adverse Effects
Frequency Not Defined
Body odor
Diarrhea
GI distress
Nausea
Dysgeusia
Alopecia
Anorexia
Dental disorders
Hives
Glossitis
Warnings
Contraindications
None reported
Cautions
Cerebral edema may occur from large increases in methionine resulting from betaine treatment
Pregnancy & Lactation
Pregnancy Category: C
Lactation: excretion in milk unknown; use with caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Methyl group donor, helps convert homocysteine to methionine, which in turn prevents the development of ocular abnormalities, mental retardation, osteoprosis, thromboembolic disease, and premature atherosclerosis observed when plasma homocysteine become elevated
Pharmacokinetics
Onset: several days
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Cystadane oral - | 1 gram/scoop powder |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
betaine oral
BETAINE - ORAL
(BEE-ta-een)
COMMON BRAND NAME(S): Cystadane
USES: This medication is used to treat high levels of a certain important body chemical (homocysteine) due to an inherited disorder (homocystinuria). Decreasing high homocysteine levels may help prevent serious blood clots, abnormal bone formation, brittle bones (osteoporosis), and eye problems (such as dislocated eye lens, nearsightedness). This medication works by decreasing blood levels of homocysteine. It does not correct the inherited disorder that causes the disease.
HOW TO USE: Take this medication by mouth as directed by your doctor, usually twice daily. Shake the bottle lightly before each use. Using the scoop provided, measure out the number of scoops prescribed by your doctor. Mix the powder with 4 to 6 ounces (120 to 180 milliliters) of water, juice, milk, or formula until dissolved, and drink immediately. The powder may also be mixed with food instead of liquid and taken immediately. Replace cap tightly after use.Dosage is based on your age, weight, medical condition, and response to therapy. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Nausea, stomach upset, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: headache that doesn't go away, vision changes.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking betaine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high methionine levels (hypermethioninemia).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as methionine/homocysteine blood levels) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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