Cystagon

DRUG DESCRIPTION

CYSTAGON® (cysteamine bitartrate) Capsules for oral administration, contain cysteamine bitartrate, a cystine depleting agent which lowers the cystine content of cells in patients with cystinosis, an inherited defect of lysosomal transport. CYSTAGON® (cysteamine bitartrate) is the bitartrate salt of cysteamine, an aminothiol, beta-mercaptoethylamine. Cysteamine bitartrate is a highly water soluble white powder with a molecular weight of 227 and the molecular formula C2H7NS • C4H6O6. It has the following chemical structure:

CYSTAGON® (cysteamine bitartrate) structural formula illustration

Each CYSTAGON® (cysteamine bitartrate) Capsule contains 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate. CYSTAGON® (cysteamine bitartrate) Capsules contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide and titanium dioxide.

What are the possible side effects of cysteamine (Cystagon)?

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

Stop using cysteamine and call your child's doctor at once if your child has any of these serious side effects (some of these may be caused by the cystinosis disorder and not by this medication):

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • ...

Read All Potential Side Effects and See Pictures of Cystagon »

What are the precautions when taking cysteamine bitartrate (Cystagon)?

Before taking cysteamine, tell your doctor or pharmacist if you are allergic to it; or to penicillamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your or your child's medical history, especially of: liver disease, stomach/gut problems (e.g., bleeding, ulcers).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your...

Read All Potential Precautions of Cystagon »


Cystagon Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, fever, loss of appetite, tiredness, drowsiness, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression), deep sleep, seizures, unusual tiredness, headache, hearing problems (e.g., buzzing/ringing in the ears), dizziness, eye/vision problems (e.g., blurred vision, loss of vision, eye pain), skin problems (e.g., thinning of the skin, stretch marks, purple bleeding patches on the elbows), bone problems (e.g., bone/joint/back pain, leg pain, broken bones).

Seek immediate medical attention if any of these rare but very serious side effects occur: black/bloody stools, stomach/abdominal pain, vomit that looks like coffee grounds.

Cysteamine can commonly cause a rash that may not be serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Seek immediate medical attention if you or your child develops any rash.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking cysteamine, tell your doctor or pharmacist if you are allergic to it; or to penicillamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your or your child's medical history, especially of: liver disease, stomach/gut problems (e.g., bleeding, ulcers).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. It could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Cystagon Patient Information Including Side Effects

Brand Names: Cystagon

Generic Name: cysteamine (Pronunciation: sis TEE a meen)

  • What is cysteamine (Cystagon)?
  • What are the possible side effects of cysteamine (Cystagon)?
  • What is the most important information I should know about cysteamine (Cystagon)?
  • What should I discuss with my health care provider before using cysteamine (Cystagon)?
  • How should I use cysteamine (Cystagon)?
  • What happens if I miss a dose (Cystagon)?
  • What happens if I overdose (Cystagon)?
  • What should I avoid while taking cysteamine (Cystagon)?
  • What other drugs will affect cysteamine (Cystagon)?
  • Where can I get more information?

What is cysteamine (Cystagon)?

Cysteamine is used to treat a condition called nephropathic cystinosis (NEF-roe-PATH-ik SIS-tin-OH-sis). It works by reducing the amount of cystine in the kidneys.

Nephropathic cystinosis is a rare genetic condition. Children with this condition develop a build-up of cystine in the kidneys, which can lead to kidney failure and other medical problems.

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

What are the possible side effects of cysteamine (Cystagon)?

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

Stop using cysteamine and call your child's doctor at once if your child has any of these serious side effects (some of these may be caused by the cystinosis disorder and not by this medication):

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • unusual bruising or streaks on the skin;
  • bone or joint problems;
  • weakness or fainting, black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • extreme drowsiness, loss of balance or coordination, seizure (convulsions);
  • confusion, hallucinations, bad dreams, or changes in mood or behavior;
  • urinating less than usual or not at all; or
  • headache, ringing in the ears, dizziness, nausea, vision problems, pain behind the eyes.

Less serious side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • loss of appetite;
  • fever, chills, body aches, flu symptoms; or
  • mild dizziness, nervous feeling.

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.

What is the most important information I should know about cysteamine (Cystagon)?

Your child should not use this medication if he or she is allergic to cysteamine or penicillamine (Cuprimine, Depen).

Before using cysteamine, tell the doctor if your child is allergic to any drugs, or if the child has skin or bone problems (including fractures), liver disease, epilepsy or other seizure disorder, a history of depression or nervous system disorder, or a history or stomach ulcer or bleeding.

There may be other medicines that can interact with cysteamine. Tell your child's doctor about all the prescription and over-the-counter medications the child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your child's doctor. Keep a list with you of all the medicines your child uses and show this list to any doctor or other healthcare provider who treats your child.

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