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DAPAGLIFLOZIN
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- Dapagliflozin was not associated with clinically meaningful prolongation of QTc interval at daily doses up to 150 mg (15-times the recommended maximum dose) in a study of healthy subjects. In addition, no clinically meaningful effect on QTc interval was observed following single doses of up to 500 mg (50-times the recommended maximum dose) of dapagliflozin in healthy subjects.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
1
24091
Other ADRs
25268
38356319
Odds Ratio = 0.064
Drug Property Information
ATC Code(s):
- A10BK01 - dapagliflozin
- A10BK0 -
- A10BK -
- A10B - "BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS"
- A10 - DRUGS USED IN DIABETES
- A - ALIMENTARY TRACT AND METABOLISM
- A10BD15 - dapagliflozin
- A10BD - Combinations of oral blood glucose lowering drugs
- A10B - "BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS"
- A10 - DRUGS USED IN DIABETES
- A - ALIMENTARY TRACT AND METABOLISM
- A10BD25 - dapagliflozin
- A10BD - Combinations of oral blood glucose lowering drugs
- A10B - "BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS"
- A10 - DRUGS USED IN DIABETES
- A - ALIMENTARY TRACT AND METABOLISM
- A10BD21 - dapagliflozin
- A10BD - Combinations of oral blood glucose lowering drugs
- A10B - "BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS"
- A10 - DRUGS USED IN DIABETES
- A - ALIMENTARY TRACT AND METABOLISM
Active Ingredient:DAPAGLIFLOZIN PROPANEDIOL
Active Ingredient UNII:887K2391VH
Drugbank ID:DB06292
PubChem Compound:9887712
CTD ID: C529054
CAS Number:461432-26-8
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
- 10.0 mg/day A10BK01
Chemical Structure: 
SMILE Code:
CCOC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)C=C1
CCOC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)C=C1
Reference
N/A
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