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Full Prescribing Information Important Safety Information For Healthcare Providers Espanol

AMITIZA Is Different

AMITIZA Is Not a Laxative or Fiber

Chloride Channels and Fluid Secretion

  • In the intestines, ClC-2 chloride channels exist to make sure the right amount of fluid is in the intestine as your body works to expel waste in the form of stool.
  • ClC-2 chloride channels help maintain fluid balance in the bowels.
  • Activation of ClC-2 chloride channels increases fluid in the bowel which can help with the passage of stool.

AMITIZA Activates Chloride Channels

  • AMITIZA goes to work in the intestine.
  • AMITIZA is the first ClC-2 chloride channel activator indicated for the treatment of Chronic Constipation in adults.
  • AMITIZA increases fluid in the bowels by specifically activating ClC-2 chloride channels in the intestines, helping stool to pass.

How AMITIZA Works

Step 1

Fluid is used by the intestines to pass waste through the bowels. When there is not enough fluid, constipation can occur.


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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