betaine (Rx)

Brand and Other Names:Cystadane

Dosing & Uses

AdultPediatric

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

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Adverse Effects

Frequency Not Defined

Body odor

Diarrhea

GI distress

Nausea

Dysgeusia

Alopecia

Anorexia

Dental disorders

Hives

Glossitis

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Warnings

Contraindications

None reported

Cautions

Cerebral edema may occur from large increases in methionine resulting from betaine treatment

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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.

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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

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Cystadane oral
-
1 gram/scoop powder

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
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 unknown 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 May 2023. 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.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.