Betaine

Betaine is used to treat homocystinuria (an inherited condition in which the body cannot break down a certain protein, causing build-up of homocysteine in the blood). Increased amounts of homocysteine in the body can cause symptoms such as extreme tiredness, seizures, dislocation of the lens of the eye, abnormal bone structure, osteoporosis (weak bones), blood clots, or decreased weight or rate of weight gain and slowed development in children. Betaine is in a class of medications called nutrients. It works by decreasing the amount of homocysteine in the blood.

Betaine comes as a powder to be mixed with food or drink and taken by mouth. It is usually taken twice a day. Take betaine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take betaine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of betaine and gradually increase your dose based on your body's response to the medication.

Your doctor may tell you to take other medications such as vitamin B₆ (pyridoxine), vitamin B₁₂ (cobalamin), and folic acid together with betaine.

Betaine controls homocystinuria but does not cure it. Continue to take betaine even if you feel well. Do not stop taking betaine without talking to your doctor.

To use betaine powder, follow these steps:

1. Shake the bottle gently before removing the cap.
2. Using the measuring scoop provided, measure the number of scoops your doctor has prescribed. One level scoop of powder is equal to 1 gram of betaine.
3. Mix the measured amount of powder with 4 to 6 ounces (120 to 180 milliliters) of water, juice, milk, or formula until the powder is completely dissolved. Betaine powder may also be mixed with food.
4. Drink or eat the mixture immediately.
5. Replace the cap tightly on the bottle after using.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking betaine,

• tell your doctor and pharmacist if you are allergic to betaine or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any medical condition.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking betaine, call your doctor.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Betaine may cause side effects. Tell your doctor if this symptom is severe or does not go away:

• nausea

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• confusion
• drowsiness
• behavior changes
• headache
• vomiting
• seizures
• loss of consciousness

Betaine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 (https://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. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

• Cystadane^®

• Trimethylglycine