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Title: |
| Amitiza (Lubiprostone) |
Number: |
| OKRX 0711402 |
Effective Date: |
| 04/11/07 for Oklahoma |
Policy based upon: |
| Prescribing information, peer reviewed literature |
Contract: |
| Check all contract provisions. |
Coverage: |
Lubiprostone (Amitiza) is considered medically necessary for the treatment of constipation when all of the following criteria are met-
1. Documentation of symptoms > 6 months in duration
2. Documentation of previous treatment failure
3. No previous history of bowel obstruction
4. No recent history of severe diarrhea
Lubiprostone (Amitiza) is considered experimental and investigational for the treatment of constipation-predominant irritable bowel syndrome (IBS), postoperative bowel dysfunction, and opioid-induced bowel dysfunction. |
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Description: |
| Lubiprostone (Amitiza) is a bicyclic fatty acid, prostaglandin E1 (PGE 1) derivative. Lubiprostone increases intestinal fluid secretion by activating specific ClC-2 chloride channels in the luminal cells of the intestinal epithelium. Clinically, lubiprostone alters stool consistency and promotes regular bowel movements, without altering serum electrolyte concentrations or producing tolerance, using this unique mechanism. This action softens the stool, increases motility in the intestine, promotes spontaneous bowel movements, and thereby alleviates signs and symptoms (e.g., bloating, discomfort, straining, hard stools) associated with chronic idiopathic constipation.
Lubiprostone (Amitiza) dosage:
For the treatment of chronic idiopathic constipation (e.g., >= 6 month history of < 3 spontaneous bowel movements per week, with at least 25% of bowel movements with hard stools, sensation of incomplete evacuation, or straining):
Oral dosage:
Adults and the elderly: 24 mcg PO twice daily with food. Periodically assess the need for continued therapy. In clinical trials, some patients received a reduction in dosage to 24 mcg once daily if significant side effects (e.g., nausea) occurred.
Children and adolescents: Safe and effective use has not been established. The most common adverse reaction is nausea. Other common adverse reactions include headache, flatulence, abdominal distention and diarrhea.
Lubiprostone (Amitiza) is pregnancy category C. |
References: |
| AmitizaTM (lubiprostone) package insert. Bethesda, MD: Sucampo Pharmaceuticals, Inc.; 2006 Jan.
Lacy BE, Campbell Levy L., Lubiprostone: a chloride channel activator.
J Clin Gastroenterol. 2007 Apr;41(4):345-51.
Rivkin A, Chagan L., Lubiprostone: chloride channel activator for chronic constipation.
Clin Ther. 2006 Dec;28(12):2008-21. Review.
Camilleri M, Bharucha AE, Ueno R, Burton D, Thomforde GM, Baxter K, McKinzie S, Zinsmeister AR., Effect of a selective chloride channel activator, lubiprostone, on gastrointestinal transit, gastric sensory, and motor functions in healthy volunteers.
Am J Physiol Gastrointest Liver Physiol. 2006 May;290(5):G942-7. | |
| CPT® only copyright 2003 American Medical Association. All Rights Reserved. | |
