Qtern Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Qtern Indications
Indications
Limitations of Use
Not for improving glycemic control in patients with type 1 diabetes.
Qtern Dosage and Administration
Adult
Children
Qtern Contraindications
Contraindications
Qtern Boxed Warnings
Not Applicable
Qtern Warnings/Precautions
Warnings/Precautions
Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, or on loop diuretics. Assess volume status, renal function before and after initiating therapy. Correct volume depletion before initiating. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat if confirmed. Monitor for resolution of ketoacidosis before restarting. Withhold (at least 3 days), if possible, prior to major surgery or procedures associated with prolonged fasting. Consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Monitor for pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections or UTIs; treat as appropriate. History of angioedema to other DPP-4 inhibitors. Severe hepatic impairment. Elderly. Pregnancy (avoid during 2nd & 3rd trimesters). Nursing mothers: not recommended.
Qtern Pharmacokinetics
Absorption
Time to maximum plasma concentration: within 2 hours (dapagliflozin); 2 hours (saxagliptin). Absolute oral bioavailability: 78% (dapagliflozin).
Distribution
Plasma protein bound: ~91% (dapagliflozin); negligible (saxagliptin).
Elimination
Dapagliflozin: renal (75%), fecal (21%). Saxagliptin: renal (75%), fecal (22%). Half-life: ~12.9 hours (dapagliflozin); 2.5 hours (saxagliptin).
Qtern Interactions
Interactions
Qtern Adverse Reactions
Adverse Reactions
Qtern Clinical Trials
See Literature
Qtern Note
Not Applicable
Qtern Patient Counseling
See Literature