Cystadane

Drug overview for CYSTADANE (betaine):

Generic name: BETAINE (BEE-ta-een)
Drug class: Betaine
Therapeutic class: Metabolic Modifiers

Betaine is a methyl group donor that functions in the normal metabolic cycle of methionine and reduces homocystinuria in patients with inborn errors of methionine metabolism.

No enhanced Uses information available for this drug.

DRUG IMAGES

CYSTADANE 1 GRAM/SCOOP POWDER

The following indications for CYSTADANE (betaine) have been approved by the FDA:

Indications:
Homocystinuria

Professional Synonyms:
Cystathionine synthase deficiency

The following dosing information is available for CYSTADANE (betaine):

Dosing
Administration
CYSTADANE
BETAINE ANHYDROUS

Dosage of betaine is expressed in terms of anhydrous drug.

The usual dosage of betaine for the management of homocystinuria in adults and children is 6 g daily administered in 2 equally divided doses. Although children ranging in age from several months to years have been treated successfully and without unusual adverse effects with 6 g daily, dosage titration may be preferable in children. Children younger than 3 years of age may receive an initial betaine dosage of 100 mg/kg daily that is subsequently increased at weekly intervals in increments of 100 mg/kg daily.

All patients may receive gradual increases in betaine dosage until the concentration of homocysteine in plasma is undetectable or present only in small amounts. Some patients have required up to 20 g daily to control concentrations of homocystine in plasma.

Betaine is administered orally as a solution prepared from the anhydrous powder. The solution should be prepared immediately before administration by dissolving the appropriate amount of powder in 120-180 mL of water. The scoop provided by the manufacturer delivers 1 g of betaine anhydrous powder per level scoopful, which apportions 1.7

mL. The solution should not be administered if it is colored or the powder does not dissolve completely.

Dosing information for CYSTADANE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
CYSTADANE 1 GRAM/SCOOP POWDER	Maintenance	Adults take 3 scoops (3 gram) by oral route 2 times per day

Generic dosing information for BETAINE ANHYDROUS
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
BETAINE 1 GRAM/SCOOP POWDER	Maintenance	Adults take 3 scoops (3 gram) by oral route 2 times per day

Severe List
Cerebral edema
Hypermethioninemia

The following adverse reaction information is available for CYSTADANE (betaine):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 2 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Cerebral edema Hypermethioninemia

There are 18 less severe adverse reactions.

More Frequent	Less Frequent
Gastrointestinal irritation Nausea	Body odor Dysgeusia Dyspepsia

Rare/Very Rare
Agitation Alopecia Anorexia Depression Diarrhea Glossitis Irritability Personality disorders Sleep disorder Tooth disorder Urinary incontinence Urticaria Vomiting

The following precautions are available for CYSTADANE (betaine):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

No enhanced Pregnancy information available for this drug.

No enhanced Lactation information available for this drug.

No enhanced Geriatric Use information available for this drug.