Eluxadoline

Eluxadoline is used to treat irritable bowel syndrome when the main symptom is diarrhea.

Eluxadoline may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Eluxadoline may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away eluxadoline is against the law.

Take with food.

Eluxadoline may cause pancreatitis or constipation, which could be severe or lead to hospitalization. Call your doctor at once if you have severe or ongoing constipation, severe pain in your upper stomach spreading to your back (with or without nausea and vomiting).

Store at room temperature away from moisture and heat.

You should not use eluxadoline if you have a pancreas disorder, severe liver disease, alcoholism, a blockage in your intestines, a gallbladder disorder, or if your gallbladder has been removed.

Eluxadoline may cause pancreatitis or constipation, which could be severe or lead to hospitalization. Call your doctor at once if you have severe or ongoing constipation, severe pain in your upper stomach spreading to your back (with or without nausea and vomiting).

You should not use eluxadoline if you are allergic to it, or if you have:

• severe constipation or a blockage in your intestines;
• a history of gallbladder obstruction, or if your gallbladder has been removed;
• digestive problems caused by a muscle valve called the sphincter of Oddi (SFINK-ter of OD-dee);
• severe liver disease;
• a pancreas disorder; or
• a habit of drinking more than 3 alcoholic beverages per day.

Tell your doctor if you have ever had:

• liver disease; or
• kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

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

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

Stop taking eluxadoline and call your doctor right away if you have:

• new or worsening stomach pain (which may be severe);
• nausea and vomiting;
• severe constipation;
• constipation lasting longer than 4 days; or
• severe pain in your upper stomach that spreads to your back.

Side effects may be more likely in older adults.

Common side effects of eluxadoline may include:

• constipation;
• nausea; or
• stomach pain.

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.

Usual Adult Dose for Irritable Bowel Syndrome:

Usual dose: 100 mg orally twice a dayComments: -Dose should be reduced to 75 mg orally twice a day for patients unable to tolerate usual dose.-If severe constipation develops, this drug should be discontinued. Use: For the treatment of irritable bowel syndrome with diarrhea.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid drinking alcohol. It may increase your risk of pancreas problems.

• Avoid taking anti-diarrhea medicine such as loperamide (Imodium) without your doctor's advice. Taking loperamide long-term while you are taking eluxadoline may cause severe constipation.

Tell your doctor about all your other medicines, especially:

• alosetron or other medications to treat irritable bowel syndrome;
• opioid pain medicine;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• bronchodilator asthma medication.

This list is not complete. Other drugs may affect eluxadoline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.