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Dosing and uses of Cystadane (betaine)

 

Adult dosage forms and 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 & take immediately

Do not take if not fully dissolved or colored

 

Pediatric dosage forms and strengths

anhydrous powder for oral solution

  • 180g/bottle

 

Homocystinuria

<3 years old: 100 mg/kg/day PO increase weekly by 100 mg/kg until plasma homocysteine is undetectable or present only in small amounts

>3 years old: 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 & take immediately

Do not take if not fully dissolved or colored

 

Cystadane (betaine) adverse (side) 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 and 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 of Cystadane (betaine)

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