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RITONAVIR


DIR Classification


Classification:Moderate-DIQT concern
Severity Score:3.0

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

  • DRUG INTERACTIONS
  • Established and Other Potentially Significant Drug Interactions
  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • QTcF interval was evaluated in a randomized, placebo and active (moxifloxacin 400 mg once-daily) controlled crossover study in 45 healthy adults, with 10 measurements over 12 hours on Day 3. The maximum mean (95% upper confidence bound) time-matched difference in QTcF from placebo after baseline correction was 5.5 (7.6) milliseconds (msec) for 400 mg twice-daily ritonavir. Ritonavir 400 mg twice daily resulted in Day 3 ritonavir exposure that was approximately 1.5 fold higher than observed with ritonavir 600 mg twice-daily dose at steady state.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
19
24073
Other ADRs
17653
38363934

Odds Ratio = 1.716

Drug Property Information



ATC Code(s):
  • J05AE03 - ritonavir
    • J05AE - Protease inhibitors
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:RITONAVIR
Active Ingredient UNII:O3J8G9O825
Drugbank ID:DB00503
PubChem Compound:392622
CTD ID:D019438
PharmGKB:PA451260
CAS Number:155213-67-5
Dosage Form(s):powder; solution; tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 1200.0 mg/day J05AE03
Chemical Structure:
SMILE Code:
CC(C)[C@H](NC(=O)N(C)CC1=CSC(=N1)C(C)C)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)OCC1=CN=CS1)CC1=CC=CC=C1

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Disclaimer:

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.

Any mention of commercial products is for clarification and not intended as endorsement.