Drug Information

Cystagon

What is CYSTAGON?

(CYSTAGON) 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 should I use CYSTAGON?

Read the Patient Information Leaflet if available from your pharmacist before you start using cysteamine and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually 4 times a day. Take this medication with food or just after a meal to reduce stomach upset. Do not give the whole capsule to children younger than 6 years. Instead, open the capsule and sprinkle the contents onto soft food such as applesauce or mashed potatoes. Eat all of the mixture right away. Do not prepare a supply for future use. The dosage is based on weight, medical condition, and response to therapy. Your doctor may direct you to take a low dose at first, gradually increasing the dose to lower the chance of side effects such as upset stomach. Your doctor will adjust your dose based on your cystine levels to find the best dose for you. Follow your doctor's directions carefully. Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.

What should I tell my health care provider before I take 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 (such as bleeding, ulcers). This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). 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 breastfeeding.

What may interact with CYSTAGON?

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.

What if I miss a dose of CYSTAGON?

If you miss a dose, take it as soon as you remember. If it is less than 2 hours before the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

What side effects may I notice from receiving CYSTAGON?

Nausea, vomiting, fever, loss of appetite, tiredness, drowsiness, and diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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 depression), deep sleep, seizures, unusual tiredness, headache, hearing problems (such as buzzing/ringing in the ears), dizziness, eye/vision problems (such as blurred vision, loss of vision, eye pain), skin problems (such as thinning of the skin, stretch marks, purple bleeding patches on the elbows), bone problems (such as bone/joint/back pain, leg pain, broken bones). Get medical help right away if you have any very serious side effects, including: 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. Get medical help right away if you or your child develops 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.

Where should I keep CYSTAGON?

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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