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FLIBANSERIN
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- The effect of ADDYI on the QT interval was evaluated in a randomized, double-blind, placebo- and active- (single dose moxifloxacin) controlled crossover study in 56 healthy men and women. Subjects in the ADDYI groups received either 50 mg twice a day (equivalent to the daily recommended dosage) or 100 mg three times a day (3 times the daily recommended dosage) administered for 5 days. The time frame for electrocardiogram (ECG) measurements covered maximum plasma concentrations of flibanserin and relevant metabolites. In this study, ADDYI did not prolong the QT interval to any clinically relevant extent. The mean increase in heart rate associated with the 100 mg three times a day dose of ADDYI compared to placebo ranged from 1.7 to 3.2 beats per minute.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
0
38381587
Odds Ratio = N/A
Drug Property Information
ATC Code(s):
- G02CX02 - flibanserin
- G02CX - Other gynecologicals
- G02C - OTHER GYNECOLOGICALS
- G02 - OTHER GYNECOLOGICALS
- G - GENITO URINARY SYSTEM AND SEX HORMONES
Active Ingredient:Flibanserin
Active Ingredient UNII:37JK4STR6Z
Drugbank ID:DB04908
PubChem Compound:6918248
CTD ID:C098107
PharmGKB:PA166153431
CAS Number:167933-07-5
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
FC(F)(F)C1=CC(=CC=C1)N1CCN(CCN2C(=O)NC3=CC=CC=C23)CC1
FC(F)(F)C1=CC(=CC=C1)N1CCN(CCN2C(=O)NC3=CC=CC=C23)CC1
Reference
N/A
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