![]() In young juvenile rats (less than 1 week old approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. IBSRELA is contraindicated in patients below 6 years of age.WARNINGS AND PRECAUTIONS Risk of Serious Dehydration in Pediatric Patients ![]() IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. IBSRELA is contraindicated in patients less than 6 years of age in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS The role of visceral hypersensitivity in irritable bowel syndrome: pharmacological targets and novel treatments. Farzaei MH, Bahramsoltani R, Abdollahi M, Rahimi R.Inflammatory and microbiota-related regulation of the intestinal epithelial barrier. Barbara G, Barbaro MR, Fuschi D, et al.The confluence of increased permeability, inflammation, and pain in irritable bowel syndrome. Irritable bowel syndrome: methods, mechanisms, and pathophysiology. Bethesda, MD: National Institutes of Health 2013. National Digestive Diseases Information Clearinghouse. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases.Management of the irritable bowel syndrome. Peripheral mechanisms in irritable bowel syndrome. Effects of irritable bowel syndrome on daily activities vary among subtypes based on results from the IBS in America Survey. Ballou S, McMahon C, Lee H-N, Katon J, Shin A, Rangan V et al.Better understanding and recognition of the disconnects, experiences, and needs of patients with irritable bowel syndrome with constipation (BURDEN IBS-C) study: results of an online questionnaire. Quigley EMM, Horn J, Kissous-Hunt M, Crozier RA, Harris LA.Irritable bowel syndrome: pathogenesis, diagnosis, treatment, and evidence-based medicine.
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