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TAMOXIFEN CITRATE


DIR Classification


Classification:Moderate-DIQT concern
Severity Score:2.0

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

  • OVERDOSAGE
  • In the same study, prolongation of the QT interval on the electrocardiogram was noted when patients were given doses higher than 250 mg/m2 loading dose, followed by maintenance doses of 80 mg/m2 of tamoxifen citrate given twice a day. For a woman with a body surface area of 1.5 m2 the minimal loading dose and maintenance doses given at which neurological symptoms and QT changes occurred were at least 6 fold higher in respect to the maximum recommended dose.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
26
24066
Other ADRs
11200
38370387

Odds Ratio = 3.702

Drug Property Information



ATC Code(s):
  • L02BA01 - tamoxifen citrate
    • L02BA - Anti-estrogens
    • L02B - HORMONE ANTAGONISTS AND RELATED AGENTS
    • L02 - ENDOCRINE THERAPY
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:TAMOXIFEN CITRATE
Active Ingredient UNII:7FRV7310N6
Drugbank ID:DB00675
PubChem Compound:2733526
CTD ID:D013629
PharmGKB:PA451581
CAS Number:10540-29-1
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 20.0 mg/day L02BA01
Chemical Structure:
SMILE Code:
CC\C(=C(/C1=CC=CC=C1)C1=CC=C(OCCN(C)C)C=C1)C1=CC=CC=C1

Reference

N/A

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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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