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Important Points About Chronic Idiopathic Constipation

Published Online: Tuesday, October 4, 2011   [ Request Print ]

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About Chronic Idiopathic Constipation
Millions of adults in the United States have chronic constipation.1 When the cause of chronic constipation is not known, the condition is referred to as chronic idiopathic constipation (CIC). A diagnosis of CIC can be made by using the American College of Gastroenterology (ACG) criteria and ruling out potential secondary causes.2,3 According to the ACG, patients may have chronic constipation if they have 2 or more of the following symptoms, lasting at least 3 months3:

  • Bowel movements that involve hard or lumpy stools
  • Feeling like their bowels are never completely empty
  • Fewer than 3 bowel movements a week

Patients May Try Self-Treatment
Patients may self-treat symptoms. Health care providers can offer suggestions to help, such as adding more dietary fiber, increasing liquid consumption, and incorporating more physical activity.2 When these actions are not sufficient, health care providers may recommend over-the-counter products (such as fiber supplements, laxatives, and stool softeners) or prescription medication.2

AMITIZA (lubiprostone) (24 mcg twice daily) for Chronic Idiopathic Constipation in Adults
AMITIZA is a prescription drug approved to treat chronic idiopathic constipation in adults.4 AMITIZA is not a laxative or fiber. AMITIZA increases fluid secretion in the bowel, helping stool to pass.

In two 4-week clinical studies:
  • the average number of spontaneous bowel movements at week 1 increased to 5.7 (n = 120) in pivotal study 1, or 5.9 (n = 119) in pivotal study 2 with AMITIZA (24 mcg twice daily) versus 3.5 (n = 122) in pivotal study 1, or 4.0 (n = 118) in pivotal study 2 with placebo.4,5
  • the majority of patients taking AMITIZA had a bowel movement within the first 24 hours.4 Between 57% and 63% of patients had a spontaneous bowel movement within 24 hours after taking Amitiza (24 mcg twice daily) versus 32% to 37% of patients taking placebo.4
  • AMITIZA improved signs and symptoms associated with chronic constipation, including straining, stool consistency, abdominal discomfort, abdominal bloating, and constipation severity, compared with placebo.4


INDICATION
AMITIZA (lubiprostone) is indicated for the treatment of chronic idiopathic constipation (24 mcg twice daily) in adults.

IMPORTANT SAFETY INFORMATION

  • AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.
  • The safety of AMITIZA in pregnancy has not been evaluated in humans. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. 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.
  • Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider.
  • AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe.
  • Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea.
  • In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316) in patients with Chronic Idiopathic Constipation (CIC), the most common adverse reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs <1%), headache (11% vs 5%), abdominal pain (8% vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%).
  • Reduce the dosage in patients with moderate and severe hepatic impairment.


Please click here for complete prescribing information for AMITIZA.

Please click here or button above to download a printable patient version.




References

  1. Higgins PD, Johanson JF. Am J Gastroenterol. 2004;99(4):750-759.
  2. Brandt LJ, Prather CM, Quigley EM, Schiller LR, Schoenfeld P, Talley NJ. Am J Gastroenterol. 2005;100(suppl 1):S5-S22.
  3. American College of Gastroenterology Chronic Constipation Task Force. Am J Gastroenterol. 2005;100(suppl 1):S1-S4.
  4. AMITIZA [package insert]. Bethesda, MD: Sucampo Pharma Americas, Inc.; 2011.
  5. Data on file. Sucampo Pharma Americas, Inc.



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