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Januvia Generic Name & Formulations
Legal Class
Rx
General Description
Sitagliptin (as phosphate) 25mg, 50mg, 100mg; tabs.
Pharmacological Class
Dipeptidyl peptidase-4 (DPP-4) inhibitor.
How Supplied
Tabs 25mg, 50mg—30, 90, 100; 100mg—30, 90, 100, 1000
Manufacturer
Generic Availability
NO
Mechanism of Action
Sitagliptin is believed to exert its actions in patients with type 2 diabetes mellitus by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by sitagliptin, thereby increasing and prolonging the action of these hormones.
Januvia 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. Not studied in patients with history of pancreatitis.
Januvia Dosage and Administration
Adult
100mg once daily. Renal impairment (eGFR ≥30–<45mL/min/1.73m2): 50mg once daily; (eGFR <30mL/min/1.73m2 or ESRD on dialysis): 25mg once daily.
Children
<18yrs: not established.
Januvia Contraindications
Not Applicable
Januvia Boxed Warnings
Not Applicable
Januvia Warnings/Precautions
Warnings/Precautions
Assess renal function before starting therapy and periodically thereafter. 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. History of angioedema to other DPP-4 inhibitors. Severe hepatic impairment. Elderly. Pregnancy. Nursing mothers.
Januvia Pharmacokinetics
Elimination
Renal (87%), fecal (13%). Half-life: ~12.4 hours.
Januvia Interactions
Interactions
May need lower dose of concomitant sulfonylurea or insulin to reduce risk of hypoglycemia.
Januvia Adverse Reactions
Adverse Reactions
Upper respiratory tract infection, nasopharyngitis, headache; pancreatitis, heart failure, hypersensitivity reactions (eg, anaphylaxis, angioedema, Stevens-Johnson syndrome), severe and disabling arthralgia, bullous pemphigoid.
Januvia Clinical Trials
See Literature
Januvia Note
Not Applicable
Januvia Patient Counseling
See Literature
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