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LORCASERIN HYDROCHLORIDE HEMIHYDRATE
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 multiple oral doses of lorcaserin 15 mg and 40 mg once daily on QTc interval was evaluated in a randomized, placebo- and active- (moxifloxacin 400 mg) controlled four-treatment arm parallel thorough QT study in 244 healthy subjects. In a study with demonstrated ability to detect small effects, the upper bound of the one-sided 95% confidence interval for the largest placebo adjusted, baseline-corrected QTc based on individual correction method (QTcI) was below 10 ms, the threshold for regulatory concern.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
1
24091
Other ADRs
6258
38375329
Odds Ratio = 0.255
Drug Property Information
ATC Code(s):
- A08AA11 - lorcaserin hydrochloride hemihydrate
- A08AA - Centrally acting antiobesity products
- A08A - "ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS"
- A08 - "ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS"
- A - ALIMENTARY TRACT AND METABOLISM
Active Ingredient:LORCASERIN HYDROCHLORIDE HEMIHYDRATE
Active Ingredient UNII:REV26SR2B4
Drugbank ID:DB04871
PubChem Compound:11658860
CAS Number:616202-92-7
Dosage Form(s):tablet; tablet, film coated, extended release
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
C[C@H]1CNCCC2=CC=C(Cl)C=C12
C[C@H]1CNCCC2=CC=C(Cl)C=C12
Reference
N/A
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