CYSTEAMINE DELAYED-RELEASE - ORAL

CYSTEAMINE DELAYED-RELEASE - ORAL

PHONETIC PRONUNCIATION: (sis-TEE-a-meen)

COMMON BRAND NAME(S): Procysbi

GENERIC NAME(S): cysteamine bitartrate

Uses

USES: This medication is used to help preserve kidney function and manage kidney damage and other problems in people with an inherited disorder that causes build-up of a certain natural substance (cystine) in the body (nephropathic cystinosis). Cystine build-up can cause problems such as kidney problems, slow growth, weak bones, and eye problems. Cysteamine helps the body get rid of cystine.


How to use CYSTEAMINE DELAYED-RELEASE - ORAL

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using cysteamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually twice a day (every 12 hours). Taking this medication with food can affect its absorption. Take this medication on an empty stomach, at least 2 hours after and at least 30 minutes before eating food. If you cannot take it without eating, you can eat a small amount of food (4 ounces or 1/2 cup) between 1 hour before and 1 hour after taking this medication. Choose one way to take this medication (either without eating or with a small amount of food) and take it the same way with every dose. Avoid high-fat food close to the time you take your cysteamine dose. Swallow the capsules whole with fruit juice (except for grapefruit juice) or water. Do not crush or chew this medication or the contents of the capsules. Do not drink alcohol while you are on treatment with this drug. Drinking alcohol may increase the amount of this medication in your body which may cause serious side effects. If you cannot swallow the capsule whole, you can open the capsule and sprinkle the contents on 4 ounces (1/2 cup) of applesauce or berry jelly and eat the mixture within 30 minutes of preparing it. Or you can sprinkle the contents into 4 ounces (1/2 cup) of fruit juice (except for grapefruit juice), stir the mixture gently until mixed, and drink it within 30 minutes. Do not crush or chew the mixture or save it for later use. The dosage is based on your weight, medical condition, and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Side Effects

SIDE EFFECTS: Nausea, vomiting, stomach/abdominal pain, fever, loss of appetite, breath/skin odor, tiredness, drowsiness, dizziness, 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 right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression, lack of concentration), deep sleep, seizures, unusual tiredness, headache, hearing problems (such as buzzing/ringing in the ears), severe dizziness, eye/vision problems (such as blurred vision, loss of vision, eye pain), skin problems (such as thinning of the skin, fragile skin, stretch marks, easy bruising), bone problems (such as bone/joint/back pain, leg pain, broken bones, overly flexible joints). Get medical help right away if you have any very serious side effects, including: signs of bleeding or ulcers in the stomach/intestines (such as black/bloody stools, severe stomach/abdominal pain, vomit that looks like coffee grounds). Cysteamine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop any rash. A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch. 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

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/intestine problems (such as bleeding, ulcers), low white blood cell count. This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Products that contain bicarbonate or carbonate may decrease the effect of this medication if taken at the same time. Therefore, if you are also taking a product that contains bicarbonate or carbonate, separate the time that you take a dose by at least one hour before or after the time that you take cysteamine delayed-release.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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PRO, 25 mg

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PRO, 75 mg

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Faq for CYSTEAMINE DELAYED-RELEASE - ORAL

Cysteamine delayed-release oral is used to treat cystinosis, a genetic disorder that causes the buildup of a certain amino acid (cystine) in the body's cells.

Cysteamine works by reducing the level of cystine in the cells, thereby preventing the damage caused by cystine buildup in various organs.

Common side effects include nausea, stomach pain, diarrhea, bad breath, vomiting, skin odor, weight loss, and headache.

It should be taken exactly as prescribed by your doctor, usually four times a day. It is recommended to take it with food or milk to minimize stomach upset.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule.

Alcohol may increase the risk of certain side effects, so it is best to avoid or limit alcohol consumption while taking this medication. Consult your doctor for personalized advice.

Cysteamine may interact with certain medications, including antacids, omeprazole, iron supplements, and other drugs that raise stomach pH. Inform your doctor about all the medications you are taking.

It is recommended to avoid using Cysteamine during pregnancy unless necessary. It is also not recommended while breastfeeding, as it may pass into breast milk. Consult your doctor for individualized guidance.

The response to Cysteamine may vary from person to person. It may take several months to see the full benefits of the medication. Follow your doctor's instructions and attend regular check-ups.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.