Betaine

Generic name: Betaine
Brand names: Cystadane
Dosage form: oral powder for reconstitution (100%)
Drug class: Nutraceutical products

Usage of Betaine

Betaine works by preventing the build-up of an amino acid called homocysteine. This amino acid can harm blood vessels and contribute to heart disease, stroke, or circulation problems.

Betaine is used to reduce homocysteine levels in people with a genetic condition called homocystinuria, in which the amino acid builds up in the body. Betaine is not a cure for homocysteinuria.

Betaine may also be used for purposes not listed in this medication guide.

Betaine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Betaine may cause serious side effects. Call your doctor at once if you have:

  • muscle weakness;
  • memory problems;
  • changes in your mental state;
  • problems with speech, balance, or walking;
  • vision changes; or
  • unusual or unpleasant body or breath odor.
  • Common side effects of betaine may include:

  • nausea; or
  • upset stomach.
  • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Betaine

    To make sure you can safely take betaine, tell your doctor about all of your medical conditions.

    Tell your doctor if you are pregnant or breast-feeding.

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    How to use Betaine

    Usual Adult Dose for Hyperhomocysteinemia:

    Initial dose: 3 grams orally twice a day -Increase the dose gradually until plasma total homocysteine is undetectable or only present in small amountsMaximum dose: Some patients have required 20 grams/dayComments:-One in vitro pharmacokinetic/pharmacodynamic study showed minimal benefit from more than twice daily dosing and 150 mg/kg/day betaine.-An initial plasma homocysteine response takes several days; steady state is reached within a month.Uses: To decreases elevated blood homocysteine levels in the treatment of homocystinuria from:-Cystathionine beta-synthase (CBS) deficiency -5,10-methylenetetrahydrofolate reductase (MTHFR) deficiencyor-Cobalamin cofactor metabolism (cbl) defect

    Usual Pediatric Dose for Hyperhomocysteinemia:

    3 years and older:Initial dose: 3 grams orally twice a day -Increase the dose gradually until plasma total homocysteine is undetectable or only present in small amountsUnder 3 years:Initial dose: 100 mg/kg/day divided into 2 daily doses -Increase weekly by 50 mg/kg increments until plasma total homocysteine is undetectable or only present in small amountsComments:-Some patients have required 20 grams/day.-One in vitro pharmacokinetic/pharmacodynamic study showed minimal benefit from more than twice daily dosing and 150 mg/kg/day betaine.-An initial plasma homocysteine response takes several days; steady state is reached within a month.Uses: To decreases elevated blood homocysteine levels in the treatment of homocystinuria from:-Cystathionine beta-synthase (CBS) deficiency -5,10-methylenetetrahydrofolate reductase (MTHFR) deficiencyor-Cobalamin cofactor metabolism (cbl) defect

    Warnings

    Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

    What other drugs will affect Betaine

    Other drugs may affect betaine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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