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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Cystadane (Betaine Anhydrous)
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Product Details
Description
Cystadane (Betaine Anhydrous) is a medication used for the treatment of homocystinuria, a rare genetic disorder characterized by high levels of homocysteine in the blood and urine. As a form of betaine, Cystadane works by helping the body to process homocysteine, thereby reducing its levels. Classified as a methylating agent, the drug is a white, granular, hygroscopic powder that is dissolved in water and taken orally.
F act Table
Formula
C5H11NO2
License
US FDA, EMA
Bioavailability
100% (oral)
Legal status
Prescription only (Rx)
Chemical Name
Trimethylglycine
Elimination half-life
About 14 hours
Dosage (Strength)
1 g per scoop (oral powder)
Pregnancy
Consult a doctor
Brands
Cystadane
Protein binding
Not significantly protein-bound
PubChem CID
247
MedlinePlus
a608043
ChEBI
15756
ATC code
A16AA06
DrugBank
DB00118
KEGG
D07761
Routes of administration
Oral
Directions
Cystadane is taken orally. Patients should measure their dose with the scoop provided and mix the powder into water, juice, milk, or food according to their doctor's instructions. Shake the bottle lightly before removing the cap to ensure the correct consistency of the powder.
The typical starting dosage may vary based on individual needs but is typically 6 grams per day given in divided doses of 3 grams twice daily. Follow a healthcare provider's directions on timing and quantity. When preparing and taking Cystadane, be aware of potential changes in methionine levels and fluid accumulation. Maintain regular check-ins with a doctor to monitor these levels and adjust the treatment as necessary.
Ingredients
Cystadane contains the active ingredient Betaine Anhydrous.
Contraindications
There are no contraindications listed on the drug label. However, avoid taking or using this medication if you have a known hypersensitivity to Betaine Anhydrous or any component of the Cystadane formulation.
Cautions
- Before beginning treatment with Cystadane, it's important to discuss the following with your healthcare provider:
- Your current health conditions
- Any allergies you may have
- All medications you are currently using
- Whether you are pregnant or breastfeeding
- Patients with homocystinuria due to CBS deficiency must have their plasma methionine levels monitored regularly due to the risk of hypermethioninemia when treated with Cystadane.
- If methionine levels exceed 1,000 micromol/L, adjustments through dietary changes and possibly a reduced dosage of Cystadane are recommended.
- Elevated methionine levels can lead to cerebral edema. Be vigilant for signs and symptoms of this condition in patients undergoing treatment.
- Close monitoring may require dosage adjustments to maintain safe methionine levels.
Side Effects
Side effects of Cystadane oral powder may include nausea, gastrointestinal distress, diarrhea, and experiencing a bad taste or odor from the medication. Some patients reported psychological changes and one instance of aspirating the powder. These side effects are based on retrospective physician reports, so their frequency may vary.
Serious adverse reactions associated with Cystadane include severe cerebral edema and hypermethioninemia, which have been noted in patients within a few weeks to six months after starting treatment. These conditions have typically been reversible upon discontinuation of the medication. Patients with these reactions often had a severe increase in plasma methionine levels. Other serious effects reported include anorexia, mood changes like agitation and depression, sleep disturbances, dental problems, skin issues like hives and abnormal odors, and urinary incontinence. If you experience any of these serious symptoms, it’s important to contact your healthcare provider immediately.
References
- Cystadane (Betaine Anhydrous) Product Monograph. Lebanon, NJ: Recordati Rare Diseases Inc.; 2018.
- Cystadane (Betaine Anhydrous) Drug Label Information. Lebanon, NJ: Recordati Rare Diseases Inc.; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14611
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