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Cystadane

Generic name: betaine
Drug class: Nutraceutical products

Medically reviewed by  A Ras MD.

What is Cystadane?

Cystadane is a prescription medicine that is used to treat homocystinuria.

Description

Cystadane® (betaine anhydrous for oral solution) is an agent for the treatment of homocystinuria. Cystadane is a white, granular, hygroscopic powder. It contains no ingredients other than anhydrous betaine. Betaine anhydrous powder is very soluble in water, soluble in methanol and ethanol, and sparingly soluble in ether.

The chemical name of betaine anhydrous powder is trimethylglycine. It has a molecular weight of 117.15. The structural formula is:

Image from Drug Label Content

 

Before taking Cystadane, tell your doctor:

  • If you are allergic to Cystadane; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cystadane with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Cystadane?

  • Tell all of your health care providers that you take Cystadane. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Follow the diet plan that your doctor told you about.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Cystadane best taken?

Use Cystadane as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Shake the bottle lightly before you take the cap off.
  • Use only the scoop that comes with the powder to measure powder.
  • Mix with 4 to 6 ounces (120 to 180 mL) of fluid such as water, milk, fruit juice, or formula.
  • Drink it right away.
  • You may also mix it with food.
  • Put the cap back on after you are done using your dose.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of Cystadane that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Cystadane?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Cystadane?

  • Store at room temperature in a dry place. Do not store in a bathroom.
  • Keep lid tightly closed.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL DISPLAY PANEL

  • CYSTADANE®
  • 1 g
  • Orphan Europe SARL
  • Immeuble “Le Wilson”
  • 70 avenue du Général de Gaulle
  • F-92800 Puteaux
  • Cystadane 1 g oral powder.
  • Betaine anhydrous
  • 1 g of powder contains 1 g of betaine anhydrous. 180 g of oral powder and three measuring spoons. Three measuring spoons (green, blue, pink) dispense 100mg, 150mg or 1g of betaine anhydrous. Lightly shake the bottle before opening. Read the package leaflet before use. ORAL USE. Keep out of the sight and reach of children. Do not store above 25°C. Keep the bottle tightly closed in order to protect from moisture. Medicinal product subject to medical prescription.
  • Shelf life after the first opening: 3 months
  • Lot:
  • EXP:

Carton

SRC: NLM .

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