cysteamine bitartrate 25 mg capsule,delayed release sprinkle

Generic name:
Cysteamine delayed-release capsule - oral

Pronunciation
(sis-TEE-a-meen)

Brand name(s)
Procysbi

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.

Read the Patient Information Leaflet and Instructions for Use if available from 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.

Nausea, vomiting, stomach/abdominal pain, fever, loss of appetite, breath/skin odor, tiredness, drowsiness, dizziness, 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 confusion, depression, lack of concentration)
• deep sleep
• unusual tiredness
• headache
• hearing problems (such as buzzing/ringing in the ears)
• 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:

• seizures
• severe/bloody diarrhea
• 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. 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.

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 (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. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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 breastfeeding.

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. 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.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as cystine or cysteamine levels, complete blood count, kidney/liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is less than 4 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.

Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep the drying agent (desiccant) in the container. Tightly close the container when not in use. 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.

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.