Generic Name: crofelemer (kroe FEL e mer)
Brand Name: Fulyzaq, Mytesi
What is crofelemer?
Crofelemer is used to treat diarrhea that is not caused by viral or bacterial infection (non-infectious). Crofelemer is given to people who are taking antiviral medications to treat HIV or AIDS.
Crofelemer is not a treatment for HIV or AIDS.
Crofelemer may also be used for purposes not listed in this medication guide.
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
You should not use crofelemer if you are allergic to it.
To make sure crofelemer is safe for you, tell your doctor if you are sick with diarrhea and vomiting or other symptoms of infection.
FDA pregnancy category C. It is not known whether crofelemer will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether crofelemer passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using crofelemer.
Do not give this medication to anyone under 18 years old without medical advice.
How should I take crofelemer?
Before you start treatment with crofelemer, your doctor may perform medical tests to make sure you do not have infectious diarrhea.
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take crofelemer with or without food.
Do not crush, chew, or break a delayed-release tablet. Swallow it whole.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking crofelemer?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Crofelemer side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using crofelemer and call your doctor at once if you have:
dark urine, jaundice (yellowing of the skin or eyes);
wheezing, chest tightness, trouble breathing; or
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Crofelemer dosing information
Usual Adult Dose for Diarrhea:
125 mg orally twice daily
Use: For symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy:
What other drugs will affect crofelemer?
Other drugs may interact with crofelemer, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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