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.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Betaine is a powder medicine that must be mixed with a liquid before using it.

Gently shake the powder medicine bottle before measuring your dose. To get the correct dose, use the measuring scoop provided with betaine.

Mix betaine powder with 4 to 6 ounces of water, juice, milk, infant formula, or soft food. Swallow the mixture right away without chewing. Do not save for later use.

Betaine doses are based on weight in young children. Your child's dose needs may change if the child gains or loses weight.

You may need frequent blood tests.

Betaine is only part of a complete program of treatment that may also include other vitamin and mineral supplements and a special diet. Follow your diet and medication routines very closely.

Store betaine powder at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

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 amounts
Maximum dose: Some patients have required 20 grams/day

Comments:
-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) deficiency
or
-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 amounts

Under 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 amounts


Comments:
-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) deficiency
or
-Cobalamin cofactor metabolism (cbl) defect

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.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Be sure to follow all dietary recommendations made by your doctor or dietitian.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to betaine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.