"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
(cysteamine bitartrate capsules)
50 mg and 150 mg
- Patient Information:
Details with Side Effects
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:
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;
- unusual bruising or streaks on the skin;
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...
Last reviewed on RxList: 6/26/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Cystagon Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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