Jentadueto Generic Name & Formulations
Linagliptin, metformin HCl; 2.5mg/500mg, 2.5mg/850mg, 2.5mg/1000mg; tabs.
Dipeptidyl peptidase-4 (DPP-4) inhibitor + biguanide.
Tabs—60, 180; XR tabs 2.5mg/1000mg—60, 180; 5mg/1000mg—30, 90
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
Not for use in patients with type 1 diabetes. Not studied in patients with a history of pancreatitis.
Jentadueto Dosage and Administration
Individualize. Take twice daily with meals. Previously not on metformin: initially 2.5mg/500mg twice daily. Previously on metformin: start with 2.5mg linagliptin and current metformin dose twice daily. Previously on linagliptin and metformin: switch on mg/mg basis. Max 2.5mg/1000mg twice daily. Renal impairment (eGFR 30–45mL/min/1.73m2): not recommended. If eGFR falls <45mL/min/1.73m2, assess risk/benefit; discontinue if eGFR falls <30mL/min/1.73m2.
<18yrs: not established.
Severe renal impairment (eGFR <30mL/min/1.73m2). Metabolic acidosis, diabetic ketoacidosis.
Jentadueto Boxed Warnings
Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, cationic drugs), ≥65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis occurs. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with eGFR 30–60mL/min/1.73m2, history of hepatic impairment, alcoholism, hypoxemia, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Suspend therapy if dehydration occurs or before surgery. Avoid if clinical or lab evidence of hepatic disease. Known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Assess renal function prior to initiation and periodically thereafter; more frequently in elderly. Discontinue if pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid is suspected or occurs. History of angioedema to other DPP-4 inhibitors. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Measure hematologic parameters annually and serum Vit. B12 at 2–3 year intervals. Premenopausal women with anovulatory: ovulation may occur. Pregnancy. Nursing mothers.
Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Concomitant cationic drugs that interfere with renal tubular transport systems (eg, ranolazine, vandetanib, dolutegravir, cimetidine) may increase metformin levels; monitor. Avoid excessive alcohol intake (potentiates effects of metformin on lactate). Antagonized by strong P-gp or CYP3A4 inducers (eg, rifampin); consider alternatives to linagliptin if used in combination. Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, calcium channel blockers, isoniazid, nicotinic acid, others may cause hyperglycemia. May need a lower dose of concomitant insulin and/or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia.
Jentadueto Adverse Reactions
Nasopharyngitis, diarrhea, cough, decreased appetite, nausea, vomiting, pruritus, pancreatitis, hypersensitivity reactions; hypoglycemia, severe and disabling arthralgia, bullous pemphigoid; rare: lactic acidosis (may be fatal).
Jentadueto Clinical Trials
Jentadueto Patient Counseling