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- TRADE NAME: Ibsrela (Ardelyx)
- INDICATIONS: Treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
- CLASS: Sodium-hydrogen exchanger 3 (NHE3) inhibitor
- HALF-LIFE: N/A (due to low absorption)
- FDA APPROVAL DATE: 09/12/2019
- CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
None known - PREGNANCY: Maternal use is not expected to result in fetal exposure to tenapanor.
Tenapanor is contraindicated in:
Patients less than 6 years of age due to the risk of serious dehydration.
Patients with known or suspected mechanical gastrointestinal obstruction.
RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
TENAPANOR IS CONTRAINDICATED IN PATIENTS LESS THAN 6 YEARS OF AGE; IN YOUNG JUVENILE RATS, TENAPANOR CAUSED DEATH PRESUMED TO BE DUE TO DEHYDRATION.
AVOID USE OF TENAPANOR IN PATIENTS 6 YEARS TO LESS THAN 12 YEARS OF AGE.
THE SAFETY AND EFFECTIVENESS OF TENAPANOR HAVE NOT BEEN ESTABLISHED IN PEDIATRIC PATIENTS LESS THAN 18 YEARS OF AGE.
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Page last updated 12/21/2024
