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Rx Item-IBSRELA - tenapanor hydrochloride tablet 50MG 60 TAB BY Ardelyx, Inc.

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Rx Item-IBSRELA - tenapanor hydrochloride tablet 50MG 60 TAB BY Ardelyx, Inc.

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NDC No. 73154-050-06 73154-0050-06 73154005006 7315405006 UPC/GTIN No. 3-73154-05006-2 373154050062 373154050062 MPN No. 5006 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.For:Irritable Bowel Syndrome
Ibsrela (tenapanor) is a first-in-class, sodium/hydrogen exchanger 3 (NHE3) inhib

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hese highlights do not include all the information needed to use IBSRELA� safely and effectively. See full prescribing information for IBSRELA.

IBSRELA (tenapanor) tablets, for oral use
Initial U.S. Approval: 2019
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
See full prescribing information for complete boxed warning.

IBSRELA is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death presumed to be due to dehydration. (4, 8.4)
Avoid use of IBSRELA in patients 6 years to less than 12 years of age. (5.1, 8.4)
The safety and effectiveness of IBSRELA have not been established in pediatric patients less than 18 years of age. (8.4)

INDICATIONS AND USAGE

IBSRELA is a sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults. (1)
DOSAGE AND ADMINISTRATION

The recommended dosage in adults is 50 mg, orally twice daily. (2)
Take immediately prior to breakfast or the first meal of the day and immediately prior to dinner. (2)

DOSAGE FORMS AND STRENGTHS

Tablets: 50 mg tenapanor. (3)
CONTRAINDICATIONS

Pediatric patients less than 6 years of age. (4, 5.1, 8.4)
Patients with known or suspected mechanical gastrointestinal obstruction. (4)

WARNINGS AND PRECAUTIONS

Diarrhea: Patients may experience severe diarrhea. If severe diarrhea occurs, suspend dosing and rehydrate patient. (5.2)
ADVERSE REACTIONS

Most common adverse reactions (?2%) are diarrhea, abdominal distension, flatulence and dizziness. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Ardelyx at 1-844-427-7352 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 9/2019

Rx Item-IBSRELA - tenapanor hydrochlorid
RX73154-050-06

Rx Item-IBSRELA - tenapanor hydrochlorid
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