Frequently Asked Questions

A: AMITIZA (8 mcg) twice daily is a prescription medicine for women 18 years and older used to treat Irritable Bowel Syndrome with Constipation (see definition below). It is a soft, pink, oval gelatin capsule.

A: Irritable Bowel Syndrome with Constipation (IBS-C) is just one form of Irritable Bowel Syndrome (IBS) in which the predominant symptom is abdominal pain, associated with constipation. Irritable Bowel Syndrome is a malfunction of your colon or intestine, the part of the digestive system that stores your solid waste materials, also called stools. Irritable Bowel Syndrome means that for at least 6 months, you have experienced abdominal pain or discomfort plus 2 or more of the following: relief with a bowel movement, fewer bowel movements a week, and/or changes in stool appearance. Additionally, in order to be classified as having IBS with Constipation, your symptoms would also include at least 2 of the following: fewer than 3 bowel movements a week, hard stools at least 25% of the time, and/or 25% or more of your bowel movements involving straining.

A: AMITIZA is not for everyone. You should talk to your healthcare provider if you:

• Know or suspect you have a bowel blockage. If you are unsure, your healthcare provider should evaluate your condition before starting AMITIZA
• Have severe diarrhea
• Have kidney or liver disease
• Are pregnant or plan to become pregnant. AMITIZA has not been studied in pregnant women and should only be used during a pregnancy if the potential benefits justify the potential risk to the fetus. Women should have a negative pregnancy test before beginning treatment with AMITIZA and need to practice effective birth control measures. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus
• Are breastfeeding. It is not known if AMITIZA passes into your milk or, if it does, what effects it has on your child
• Cannot swallow a capsule

Tell your healthcare provider about all the medicines you take or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

A: Do not take AMITIZA if:

• You know or suspect you have a bowel blockage
• You have severe diarrhea
• You are pregnant, unless, after discussion with your healthcare provider, the potential benefit justifies the potential risk to the fetus
• You are allergic to AMITIZA or any of its ingredients. See the last question for a complete list of ingredients

A: AMITIZA has not been studied in pregnant women and should only be used during a pregnancy if the potential benefits justify the potential risk to the fetus. So, if you are pregnant or plan to become pregnant, tell your healthcare provider. Women should have a negative pregnancy test before beginning treatment with AMITIZA and need to practice effective birth control measures. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus.

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.

A: 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.

A: AMITIZA needs to be taken twice a day, or as prescribed by your healthcare provider.

AMITIZA should be taken with food and water. Swallow the gelatin capsule whole and do not break it apart or chew it. Tell your doctor if you have liver problems.

A: If you miss a dose of AMITIZA, just skip that dose. 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 then take your normal dose. Tell your doctor if you have liver problems.

A: Although studies have suggested a low risk of interactions with other drugs and products, only your healthcare provider can decide whether AMITIZA is right for you.

A: 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.

Medicines are sometimes prescribed for conditions that are not in the patient information leaflet. Use AMITIZA only the way your healthcare provider tells you. Do not share AMITIZA with other people, even if they have the same symptoms you have. It may harm them.

A: This is a summary of the most important information about AMITIZA. If you would like more information, talk with your healthcare professional. If you would like more information about AMITIZA, you may access the complete Prescribing Information by clicking here.

A: Active ingredient: lubiprostone. Inactive ingredients: medium-chain triglycerides, gelatin, sorbitol, ferric oxide, titanium dioxide, and purified water.