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GUANFACINE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

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

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • In a thorough QT study, the administration of two dose levels of immediate-release guanfacine (4 mg and 8 mg) produced concentrations approximately 2 to 4 times the concentrations observed with the maximum recommended dose of guanfacine of 0.12 mg/kg. Guanfacine was not shown to prolong the QTc interval to any clinically relevant extent.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
77
24015
Other ADRs
5915
38375672

Odds Ratio = 20.803

Drug Property Information



ATC Code(s):
  • C02AC02 - guanfacine
    • C02AC - Imidazoline receptor agonists
    • C02A - "ANTIADRENERGIC AGENTS, CENTRALLY ACTING"
    • C02 - ANTIHYPERTENSIVES
    • C - CARDIOVASCULAR SYSTEM
Active Ingredient:GUANFACINE HYDROCHLORIDE
Active Ingredient UNII:PML56A160O
Drugbank ID:DB01018
PubChem Compound:3519
CTD ID:D016316
PharmGKB:PA449825
CAS Number:29110-47-2
Dosage Form(s):tablet, extended release
Route(s) Of Administrator:oral
Daily Dose:
  • 3.0 mg/day C02AC02
Chemical Structure:
SMILE Code:
NC(=N)NC(=O)CC1=C(Cl)C=CC=C1Cl

Reference

1: Use of ECG restitution (beat-to-beat QT-TQ interval analysis) to assess arrhythmogenic risk of QTc prolongation with guanfacine.

[Fossa Anthony A,Zhou Meijian,Robinson Antoine,Purkayastha Jaideep,Martin Patrick]
Ann Noninvasive Electrocardiol,2014 Nov;19(6):582-94. PMID: 25200912

2: Alpha-2 agonists for attention-deficit/hyperactivity disorder in youth: a systematic review and meta-analysis of monotherapy and add-on trials to stimulant therapy.

[Hirota Tomoya,Schwartz Shimon,Correll Christoph U]
J Am Acad Child Adolesc Psychiatry,2014 Feb;53(2):153-73. PMID: 24472251

3: Risk of serious cardiovascular problems with medications for attention-deficit hyperactivity disorder.

[Martinez-Raga Jose,Knecht Carlos,Szerman Nestor,Martinez María I]
CNS Drugs,2013 Jan;27(1):15-30. PMID: 23160939

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The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.

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