Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.ĪMITIZA should not be administered to patients that have severe diarrhea. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. The safety of AMITIZA in pregnancy has not been evaluated in humans. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated prior to initiating AMITIZA treatment. AMITIZA should not be used in patients with a known hypersensitivity to any components of the formulation and in patients with a history of mechanical gastrointestinal obstruction.
Food and Drug Administration (FDA) in January 2006 for the treatment of chronic idiopathic constipation in adults, is an oral treatment that works by increasing fluid secretion in the small intestine by activating ClC-2 chloride channels, and thereby increasing the passage of the stool and improving symptoms associated with chronic idiopathic constipation.ĪMITIZA is indicated for the treatment of chronic idiopathic constipation in the adult population. The condition is approximately 2 to 2.5 times more prevalent in women than men, and women are more likely to report a history of constipation, whereas men are more likely to report diarrhea.ĪMITIZA, approved by the U.S. Although people with IBS-C report suffering from many of the same symptoms associated with constipation, the presence of pain and discomfort is what differentiates IBS-C from chronic constipation. In IBS-C, symptoms are present for at least 12 weeks (these do not need to be consecutive) over a 12-month period. Three main types of IBS exist: constipation-predominant (IBS-C), diarrhea-predominant (IBS-D) and alternating constipation and diarrhea (IBS-A). The condition can significantly interfere with daily activities and reduce patients' quality of life, resulting in absences from school, missed work and reduced productivity. Irritable bowel syndrome (IBS) is a chronic disorder characterized by multiple symptoms of abdominal pain and discomfort, bloating, and changes of bowel habits such as constipation and/or diarrhea. Dose-dependent trends were also seen for adverse events, with incidence and drop-out rates rising with the dose of AMITIZA. Overall, the improvements were typically highest in the highest AMITIZA dose group (48 micrograms/day). Comparisons between the groups revealed that during the first and second months, the improvements in abdominal discomfort/pain and SBM frequency rates were more than doubled in all AMITIZA groups. Significant improvements versus placebo were observed for at least two of the three months for abdominal pain/discomfort, abdominal bloating, frequency of spontaneous bowel movements (SBM), stool consistency, bowel straining and assessments of constipation severity. In an electronic diary, patients recorded data related to dosing, side effects and IBS-C symptoms including bloating, abdominal pain/discomfort, frequency of and straining during bowel movements, stool consistency and rescue medication use. In a double-blind, placebo-controlled, dose-ranging study, approximately 200 patients with diagnosed IBS-C (per the Rome II criteria) were randomized to receive placebo or AMITIZA (8, 16 or 24 micrograms) twice-daily for 12 weeks. This is the first time AMITIZA has been tested exclusively in the IBS-C population. AMITIZA was approved for use for chronic idiopathic constipation in adults on January 31, 2006.
#Amitiza for ibs constipation Activator#
"There are several additional studies underway that further explore the uses of AMITIZA in this patient population and we look forward to learning the findings."ĪMITIZA is a novel selective chloride channel activator that has been shown to be effective and well-tolerated in a number of well-controlled clinical trials in patients with chronic idiopathic constipation. "The results of this study suggest that AMITIZA may help improve several of the most frequently reported symptoms of IBS-C, including abdominal pain, bloating and discomfort," said John Johanson, M.D., primary investigator and clinical associate professor, University of Illinois College of Medicine. The study was presented today at Digestive Disease Week, the largest annual meeting of digestive disease specialists. IBS is a condition that affects nearly 30 million people in North America and accounts for 25-50 percent of referrals to gastroenterologists. A new study found that AMITIZA(TM) (lubiprostone) may help relieve the symptoms associated with constipation-predominant irritable bowel syndrome (IBS-C).
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