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SAXAGLIPTIN
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- OVERDOSAGE
- In a controlled clinical trial, once-daily, orally-administered ONGLYZA in healthy subjects at doses up to 400 mg daily for 2 weeks (80-times the MRHD) had no dose-related clinical adverse reactions and no clinically meaningful effect on QTc interval or heart rate.
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- In a randomized, double-blind, placebo-controlled, 4-way crossover, active comparator study using moxifloxacin in 40 healthy subjects, ONGLYZA was not associated with clinically meaningful prolongation of the QTc interval or heart rate at daily doses up to 40 mg (8-times the MRHD).
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
7236
38374351
Odds Ratio = 0.0
Drug Property Information
ATC Code(s):
- A10BH03 - saxagliptin
- A10BH0 -
- A10BH - Dipeptidyl peptidase 4 (DPP-4) inhibitors
- A10B - "BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS"
- A10 - DRUGS USED IN DIABETES
- A - ALIMENTARY TRACT AND METABOLISM
- A10BD10 - saxagliptin
- 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 - saxagliptin
- 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 - saxagliptin
- 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:saxagliptin hydrochloride
Active Ingredient UNII:Z8J84YIX6L
Drugbank ID:DB06335
PubChem Compound:11243969
PharmGKB:PA165958362
CAS Number:361442-04-8
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
- 5.0 mg/day A10BH03
Chemical Structure: 
SMILE Code:
[H][C@@]12C[C@]1([H])N([C@@H](C2)C#N)C(=O)[C@@H](N)C12CC3CC(CC(O)(C3)C1)C2
[H][C@@]12C[C@]1([H])N([C@@H](C2)C#N)C(=O)[C@@H](N)C12CC3CC(CC(O)(C3)C1)C2
Reference
N/A
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