AMITIZA (lubiprostone) 24 mcg twice daily is approved to treat Chronic Idiopathic Constipation in adults. "Idiopathic" means the cause of the constipation is unknown and not due to an underlying illness or medication. AMITIZA 8 mcg twice daily is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years of age and older.
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 (24 mcg) twice daily, orange capsules for Chronic Idiopathic Constipation are nausea, diarrhea, and headache. 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.
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.
§You must meet Eligibility Requirements.
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