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DARUNAVIR
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- DRUG INTERACTIONS
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- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- In a thorough QT/QTc study in 40 healthy subjects, PREZISTA/ritonavir doses of 1.33 times the maximum recommended dose did not affect the QT/QTc interval.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
31
42881
Other ADRs
3335
14113944
Odds Ratio = 3.06
Drug Property Information
ATC Code(s):
- J05AE10 - darunavir
- J05AE - Protease inhibitors
- J05A - DIRECT ACTING ANTIVIRALS
- J05 - ANTIVIRALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
- J05AR14 - darunavir
- J05AR - "Antivirals for treatment of HIV infections, combinations"
- J05A - DIRECT ACTING ANTIVIRALS
- J05 - ANTIVIRALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:darunavir ethanolate
Active Ingredient UNII:33O78XF0BW
Drugbank ID:DB01264
PubChem Compound:213039
CAS Number:206361-99-1
Dosage Form(s):suspension; tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
- 1200.0 mg/day J05AE10
Chemical Structure: 
SMILE Code:
CC(C)CN(C[C@H]([C@H](CC1=CC=CC=C1)NC(=O)O[C@H]2CO[C@@H]3[C@H]2CCO3)O)S(=O)(=O)C4=CC=C(C=C4)N
CC(C)CN(C[C@H]([C@H](CC1=CC=CC=C1)NC(=O)O[C@H]2CO[C@@H]3[C@H]2CCO3)O)S(=O)(=O)C4=CC=C(C=C4)N
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: No evident association between efavirenz use and suicidality was identified from a disproportionality analysis using the FAERS database.
[Napoli Andrew A,Wood Jennifer J,Coumbis John J,Soitkar Amit M,Seekins Daniel W,Tilson Hugh H]J Int AIDS Soc.2014 Sep 4;17:19214. doi: 10.7448/IAS.17.1.19214. eCollection 2014. PMID: 25192857
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