Crofelemer

Generic Name: crofelemer (kroe-FEL-e-mer)
Brand Name: Fulyzaq

Crofelemer is used for:

Treating certain types of diarrhea in patients who are being treated for HIV infection. It may also be used for other conditions as determined by your doctor.

Crofelemer is an antidiarrhea medicine. It works by decreasing the amount of fluid in the bowel to decrease water loss by diarrhea.

Do NOT use crofelemer if:

  • you are allergic to any ingredient in crofelemer

Contact your doctor or health care provider right away if any of these apply to you.

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Before using crofelemer:

Some medical conditions may interact with crofelemer. 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 celiac disease, pancreas inflammation (pancreatitis), Crohn disease, ulcerative colitis, problems absorbing nutrients from food, or any other stomach or bowel problem that may cause diarrhea
  • if you have liver problems
  • if you have diarrhea caused by an infection

Some MEDICINES MAY INTERACT with crofelemer. However, no specific interactions with crofelemer are known at this time.

Ask your health care provider if crofelemer 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 crofelemer:

Use crofelemer as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take crofelemer by mouth with or without food.
  • Swallow crofelemer whole. Do not break, crush, or chew before swallowing.
  • If you miss a dose of crofelemer, take it as soon as possible. If it is almost time for 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 crofelemer.

Important safety information:

  • Crofelemer should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if crofelemer can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using crofelemer while you are pregnant. Crofelemer is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or crofelemer to the baby.

Possible side effects of crofelemer:

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:

Back pain; cough; gas; joint pain; nausea; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); increased or painful urination; yellowing of the skin or eyes.

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.

Proper storage of crofelemer:

Store crofelemer at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) are permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep crofelemer out of the reach of children and away from pets.

General information:

  • If you have any questions about crofelemer, please talk with your doctor, pharmacist, or other health care provider.
  • Crofelemer is 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 crofelemer 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 crofelemer. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to crofelemer. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using crofelemer.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

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.

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