Cysteamine delayed-release capsules
Generic Name: cysteamine (sis-TEE-a-meen)
Brand Name: Procysbi
Cysteamine delayed-release capsules are used for:
Managing nephropathic cystinosis (a rare, serious kidney disease).
Cysteamine delayed-release capsules are a cystine-depleting agent. It works by reducing the amount of cystine in the body.
Do NOT use cysteamine delayed-release capsules if:
- you are allergic to any ingredient in cysteamine delayed-release capsules or to penicillamine
Contact your doctor or health care provider right away if any of these apply to you.
Before using cysteamine delayed-release capsules:
Some medical conditions may interact with cysteamine delayed-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of stomach or bowel problems (eg, ulcers, bleeding), nervous system problems, seizures, sleepiness, mental or mood problems (eg, depression), or exhaustion
- if you have a skin rash, bone problems, liver problems, or blood problems
Some MEDICINES MAY INTERACT with cysteamine delayed-release capsules. However, no specific interactions with cysteamine delayed-release capsules are known at this time.
Ask your health care provider if cysteamine delayed-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use cysteamine delayed-release capsules:
Use cysteamine delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with cysteamine delayed-release capsules. Talk to your pharmacist if you have questions about this information.
- Take cysteamine delayed-release capsules the same way each time, either without food or with a small amount of food. If you take cysteamine delayed-release capsules without food, take it at least 30 minutes before you eat or at least 2 hours after you eat. If you are not able to take cysteamine delayed-release capsules without food, you may eat a small amount of food (half cup) between 1 hour before you take cysteamine delayed-release capsules and 1 hour after you take it. Check with your doctor if you have any questions about how to take cysteamine delayed-release capsules.
- Do not eat foods high in fat close to the time you take cysteamine delayed-release capsules.
- Swallow cysteamine delayed-release capsules whole. Do not crush or chew before swallowing. If you cannot swallow the capsule whole, you can open it and sprinkle the contents over 4 oz of applesauce or berry jelly. Swallow the mixture within 30 minutes.
- You may also open the capsule and sprinkle the contents into 4 oz of apple juice or orange juice. Shake gently for 5 minutes. Drink the mixture within 30 minutes.
- If the patient is taking cysteamine delayed-release capsules through a nasogastric (NG) tube or gastric tube, follow the instructions for use in the extra patient leaflet.
- Continue to take cysteamine delayed-release capsules even if you feel well. Do not miss any doses.
- If you miss a dose of cysteamine delayed-release capsules, take it as soon as possible. If it is within 4 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use cysteamine delayed-release capsules.
Important safety information:
- Cysteamine delayed-release capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use cysteamine delayed-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose or change your dose of cysteamine delayed-release capsules without first checking with your doctor.
- Cysteamine delayed-release capsules may cause abnormal change of the skin and bones (eg, stretch marks; bone injuries, such as broken bones; deformed bones; joint problems). Tell your doctor right away if you have any skin changes, or unusual bone or joint pain.
- Lab tests, including blood cell counts, eye exams, and liver function, may be performed while you use cysteamine delayed-release capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Cysteamine delayed-release capsules should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using cysteamine delayed-release capsules while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking cysteamine delayed-release capsules.
Possible side effects of cysteamine delayed-release capsules:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Decreased appetite; diarrhea; drowsiness; lack of energy; nausea; stomach pain or discomfort; tiredness; unpleasant breath, urine, or skin odor; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; buzzing or "whooshing" sound in the ear; confusion; dizziness; eye pain; fever, chills, or sore throat; headache; mental or mood changes (eg, depression); persistent or severe nausea, vomiting, loss of appetite, or stomach pain; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent drowsiness or lack of energy; unusual tiredness or weakness; vision changes (eg, blurred vision, double vision, loss of vision); vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry, or bloody stools; decreased motor activity; severe or persistent vomiting; severe stomach or lower back pain.Proper storage of cysteamine delayed-release capsules:
Store cysteamine delayed-release capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep cysteamine delayed-release capsules tightly closed in the original bottle. Do not store in the bathroom. Keep cysteamine delayed-release capsules out of the reach of children and away from pets.
- If you have any questions about cysteamine delayed-release capsules, please talk with your doctor, pharmacist, or other health care provider.
- Cysteamine delayed-release capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take cysteamine delayed-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about cysteamine delayed-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to cysteamine delayed-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using cysteamine delayed-release capsules.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.