Mytesi (Crofelemer) – Side Effects, Interactions, Uses, Dosage, Warnings

Crofelemer is used in adults to treat diarrhea that may be caused by taking antiviral medicine to treat HIV (human immunodeficiency virus). Crofelemer is not for use in treating diarrhea that is caused by an infection.

Crofelemer is not a treatment for HIV.

Crofelemer may also be used for purposes not listed in this medication guide.

uses

What is Mytesi (Crofelemer) used for?

  • Pseudomembranous Colitis
  • Salmonella Enteric Fever
  • Strongyloidiasis
  • Infectious Diarrhea/Enterocolitis/Gastroenteritis
  • Diarrhea

warnings

What is the most important information I should know about Mytesi (Crofelemer)?

Tell your doctor if you are sick with diarrhea and vomiting or other symptoms of infection.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Crofelemer is not approved for use by anyone younger than 18 years old.

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Side Effects

What are the side effects of Mytesi (Crofelemer)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • dark urine, jaundice (yellowing of the skin or eyes);
  • wheezing, chest tightness, trouble breathing; or
  • worsening diarrhea.

Common side effects may include:

  • abnormal blood tests;
  • gas; or
  • cold symptoms such as stuffy nose, sneezing, cough.

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.

Pregnancy & Breastfeeding

Can I take Mytesi (Crofelemer) if I’m pregnant or breastfeeding?

C
Risk cannot be ruled out
Based on FDA pregnancy categories

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Interactions

What drugs and food should I avoid while taking Mytesi (Crofelemer)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Dosage Guidelines & Tips

How to take Mytesi (Crofelemer)?

Use Mytesi (Crofelemer) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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 and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Swallow the tablet whole and do not crush, chew, or break it.

You may take crofelemer with or without food.

Store at room temperature away from moisture and heat.

What should I do if I missed a dose of Mytesi (Crofelemer)?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Overdose Signs

What happens if I overdose on Mytesi (Crofelemer)?

If you think you or someone else may have overdosed on: Mytesi (Crofelemer),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn't breathing after taking Mytesi (Crofelemer), call 911

911

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125SLXP

Color: white

Shape: oval

Form: film coated

Imprint: 125SLXP

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