Talk to your doctor. Ask about AMITIZA.
Full Prescribing Information Important Safety Information For Healthcare Providers Espanol

Directions for Use

AMITIZA needs to be taken twice a day or as prescribed by your healthcare provider, and for as long as they recommend. You and your doctor should regularly assess the need for continued therapy.

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 or if you are taking a diphenylheptane opioid (e.g., methadone). Also, remember to check in regularly with your healthcare provider, so they can monitor your progress, and make adjustments as needed.

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.

Here are some 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 or daily as prescribed by your healthcare professional. The capsule should be swallowed whole and should not be broken apart or chewed. Patients on treatment who experience severe nausea, dyspnea or diarrhea should inform their healthcare provider. If your diarrhea becomes severe, stop taking AMITIZA and tell your healthcare provider.
  • If you miss a dose of AMITIZA, just skip that dose. Do not take two 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.
  • Store AMITIZA at room temperature between 59° to 86°F (15° to 30°C) and protect from light and extreme temperatures. AMITIZA should be stored in a tightly closed, child-proof container and kept out of the reach of children.
  • Do not use AMITIZA past the expiration date shown on the package.
  • As you continue to take AMITIZA, keep track of your progress. Use the Progress Checker to keep track of your symptoms and follow your progress.

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 (HCP) 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 and water, if it becomes severe, tell your HCP. If your diarrhea becomes severe, stop taking AMITIZA and tell your HCP.

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 HCP if you experience these symptoms.

The most common side effects of taking AMITIZA (24 mcg) twice daily are nausea, diarrhea, headache, abdominal pain, abdominal distension, and gas for patients treated for CIC; nausea and diarrhea for patients treated for Opioid-Induced Constipation. The most common side effects of taking AMITIZA (8 mcg) twice daily for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA.

Tell your HCP if you are taking a diphenylheptane opioid (e.g., methadone).

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 HCP to evaluate the risks to the fetus. Tell your HCP if you are nursing and monitor infants for diarrhea.

Tell your HCP if you have liver problems.

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.

Indication

AMITIZA (lubiprostone) 24 mcg capsules twice daily is approved to treat Chronic Idiopathic Constipation (CIC) in adults. "Idiopathic" means the cause of the constipation is unknown and not due to an underlying illness or medication. AMITIZA 24 mcg twice daily is also approved to treat constipation caused by opioids, a type of prescription pain medicine, in adults with chronic, non-cancer pain. The effectiveness of AMITIZA has not been established if you are taking a diphenylheptane opioid (e.g., methadone). AMITIZA 8 mcg capsules twice daily is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years of age and older.

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