Directions for Use
It's important to take AMITIZA as prescribed, and for as long as your healthcare provider recommends—NOT just when you have symptoms. You and your doctor should regularly assess the need for continued therapy.
Here are some other important things to keep in mind when taking AMITIZA.
- AMITIZA should be taken twice daily with food and water to reduce potential symptoms of nausea. The capsule should be taken once in the morning and once in the evening daily as prescribed. The capsule should be swallowed whole and should not be broken apart or chewed. Patients on treatment who experience severe nausea, diarrhea, or dyspnea should inform their physician. Tell your doctor if you have liver problems.
- If you miss a dose of AMITIZA , do not take 2 capsules to make up for the missed dose. Instead, just wait until the next time you are supposed to take it, and take your normal dose.
- Store AMITIZA at room temperature in a childproof container that is tightly closed and out of the reach of children.
- Do not use AMITIZA past the expiration date shown on the package.
- As you continue to take AMITIZA, use the AMITIZA Progress Checker to keep track of your symptoms and follow your progress. Share this information with your healthcare provider in a follow-up visit.
When you fill your prescription, you'll see it comes with accompanying information. Be sure to read this information carefully before you start taking AMITIZA. Then, each time you get more AMITIZA, read the accompanying information because there may be important new information on safety or other factors.
Of course, this information does not take the place of talking to your healthcare provider.
AMITIZA (lubiprostone) 8 mcg twice daily is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years of age and older.
Important Safety Information
AMITIZA (lubiprostone) is not for everyone. If you know or suspect you have a bowel blockage, do not take AMITIZA. If you are unsure, your healthcare provider should evaluate your condition before starting AMITIZA. You should not take AMITIZA if you have severe diarrhea.
Some patients taking AMITIZA may experience nausea or diarrhea. If nausea occurs, take AMITIZA with food. If your nausea or diarrhea becomes severe, tell your healthcare provider.
Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your healthcare provider if you experience these symptoms.
The most common side effects of taking AMITIZA (8 mcg) twice daily, pink capsules for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA.
AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus. Tell your doctor if you are nursing and monitor infants for diarrhea.
Tell your doctor if you have liver problems.
Please click here for complete Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.