September 3, 2015
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"The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

Opioids are a class of drugs that are used to treat and manage pain. A comm"...




In a clinical study, a 10 year-old patient was administered lipase doses over the maximum lipase dose of 2500 lipase units/kg/meal (Dose Stabilization 2799 lipase units/kg/meal; Wash-out/Re-Stabilization 2783 lipase units/kg/meal; and PERTZYE 2720 lipase units/kg/meal). Despite the administration of this slightly (10%) higher than recommended dose, no gastrointestinal AEs were reported for this subject.

Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]. High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment [see WARNINGS AND PRECAUTIONS].



Last reviewed on RxList: 5/24/2012
This monograph has been modified to include the generic and brand name in many instances.


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