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PRUCALOPRIDE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • At a dose 5 times the maximum approved recommended dose, MOTEGRITY does not prolong the QT interval to any clinically relevant extent.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
1144
38380443

Odds Ratio = 0.0

Drug Property Information



ATC Code(s):
  • A06AX05 - prucalopride
    • A06AX0 -
    • A06AX - Other laxatives
    • A06A - LAXATIVES
    • A06 - LAXATIVES
    • A - ALIMENTARY TRACT AND METABOLISM
Active Ingredient:PRUCALOPRIDE SUCCINATE
Active Ingredient UNII:4V2G75E1CK
Drugbank ID:DB06480
PubChem Compound:3052762
CTD ID: C406662
PharmGKB:
CAS Number:179474-81-8
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 2.0 mg/day A06AX05
Chemical Structure:
SMILE Code:
COCCCN1CCC(CC1)NC(=O)C1=C2OCCC2=C(N)C(Cl)=C1

Reference

1: Patient considerations in the management of chronic constipation: focus on prucalopride.

[Shin Andrea]
Patient Prefer Adherence,2016 Jul 28;10:1373-84. PMID: 27528801

2: Systematic review: cardiovascular safety profile of 5-HT(4) agonists developed for gastrointestinal disorders.

[Tack J,Camilleri M,Chang L,Chey W D,Galligan J J,Lacy B E,Müller-Lissner S,Quigley E M M,Schuurkes J,De Maeyer J H,Stanghellini V]
Aliment Pharmacol Ther,2012 Apr;35(7):745-67. PMID: 22356640

3: The action of the novel gastrointestinal prokinetic prucalopride on the HERG K+ channel and the common T897 polymorph.

[Chapman Hugh,Pasternack Michael]
Eur J Pharmacol,2007 Jan 12;554(2-3):98-105. PMID: 17109852

4: Pharmacological treatment of irritable bowel syndrome--from concept to sales.

[Kamm Michael A]
Eur J Surg Suppl,2002;(587):10-5. PMID: 16144196

5: Review article: the complexity of drug development for irritable bowel syndrome.

[Kamm M A]
Aliment Pharmacol Ther,2002 Mar;16(3):343-51. PMID: 11876686

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