Indications for: JENTADUETO XR
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.
Individualize. Swallow whole. Take once daily with a meal. Currently not treated with metformin: initially 5mg/1000mg once daily. Already treated with metformin: start with 5mg linagliptin and current metformin dose once daily. Already treated with linagliptin and metformin or Jentadueto: switch to XR tabs containing 5mg linagliptin and current metformin dose once daily. Max 5mg/2000mg 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.
JENTADUETO XR Contraindications:
Severe renal impairment (eGFR <30mL/min/1.73m2). Metabolic acidosis, diabetic ketoacidosis.
JENTADUETO XR Warnings/Precautions:
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. Consider risks/benefits in patients with 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.
JENTADUETO XR Classification:
Dipeptidyl peptidase-4 (DPP-4) inhibitor + biguanide.
JENTADUETO XR Interactions:
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. Consider a lower dose of concomitant insulin and/or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia.
Nasopharyngitis, diarrhea, cough, decreased appetite, nausea, vomiting, pruritus, pancreatitis, hypersensitivity reactions; hypoglycemia, severe and disabling arthralgia, bullous pemphigoid; rare: lactic acidosis (may be fatal).
Generic Drug Availability:
Tabs—60, 180; XR tabs 2.5mg/1000mg—60, 180; 5mg/1000mg—30, 90