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Onglyza Generic Name & Formulations
Legal Class
Rx
General Description
Saxagliptin 2.5mg, 5mg; tabs.
Pharmacological Class
Dipeptidyl peptidase-4 (DPP-4) inhibitor.
How Supplied
Tabs—30, 90
Manufacturer
Generic Availability
NO
Onglyza Indications
Indications
Adjunct to diet and exercise in type 2 diabetes, as monotherapy or combination therapy.
Limitations of Use
Not for treatment of type 1 diabetes or diabetic ketoacidosis.
Onglyza Dosage and Administration
Adult
Swallow whole. 2.5mg or 5mg once daily. Moderate or severe renal impairment or ESRD requiring hemodialysis (CrCl ≤50mL/min), or concomitant strong CYP3A4/5 inhibitors: 2.5mg once daily. Give dose after hemodialysis.
Children
<18yrs: not established.
Onglyza Contraindications
Not Applicable
Onglyza Boxed Warnings
Not Applicable
Onglyza Warnings/Precautions
Warnings/Precautions
Assess renal function before starting therapy and periodically thereafter. Monitor for signs/symptoms of pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. Consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. History of angioedema to other DPP4 inhibitors. Pregnancy. Nursing mothers.
Onglyza Pharmacokinetics
See Literature
Onglyza Interactions
Interactions
Potentiated by strong CYP3A4/5 inhibitors (eg, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin). May need lower dose of concomitant sulfonylurea or insulin to reduce risk of hypoglycemia.
Onglyza Adverse Reactions
Adverse Reactions
Upper respiratory tract infection, UTI, headache, peripheral edema (with thiazolidinediones); hypoglycemia (with sulfonylureas or insulin), hypersensitivity reactions (eg, anaphylaxis, angioedema, exfoliative skin conditions), pancreatitis, heart failure, severe and disabling arthralgia, bullous pemphigoid.
Onglyza Clinical Trials
See Literature
Onglyza Note
Not Applicable
Onglyza Patient Counseling
See Literature
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