Tiglipza Plus

Adjunct to diet & exercise to improve glycemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated w/ combination of sitagliptin & metformin.

Individualized dosage while not exceeding max recommended daily dose of 100 mg sitagliptin.

Hypersensitivity. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma. Severe renal impairment (eGFR <30 mL/min/1.73 m²). Temporarily discontinue use in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.

Discontinue use if hypersensitivity reaction, pancreatitis or bullous pemphigoid is suspected; evidence of renal impairment is present in patients in whom development of renal dysfunction is anticipated; hypoxic states occur. Temporarily discontinue use at the time of or prior to radiologic studies, & w/hold for 48 hr subsequent to the procedure in patients w/ eGFR ≥30-<60 mL/min/1.73 m², in patients w/ history of hepatic impairment, alcoholism, or heart failure, or in patients who will be administered intra-arterial iodinated contrast. Temporarily suspend use for any surgical procedure (except minor procedures not associated w/ restricted intake of food & fluids). Promptly w/hold treatment in presence of any condition associated w/ hypoxemia, dehydration, or sepsis. W/holding treatment may be necessary at times when temporary loss of glycemic control occurs when a patient stabilized on any diabetic regimen is exposed to stress eg, fever, trauma, infection, or surgery. Avoid use in patients w/ clinical or lab evidence of hepatic disease. Not to be used in patients w/ type 1 diabetes or for diabetic ketoacidosis. Lactic acidosis. Assess renal function & verify as normal prior to initiation of therapy & at least annually thereafter. Consider lowering dose of sulfonylurea or insulin when used in combination to reduce risk of sulfonylurea- or insulin-induced hypoglycemia. Annually measure hematologic parameters. Promptly evaluate for evidence of ketoacidosis or lactic acidosis in patient w/ type 2 diabetes previously well controlled on Tiglipza Plus who develops lab abnormalities or clinical illness (especially vague & poorly defined illness); stop immediately & initiate other appropriate corrective measures if acidosis occurs. Caution against excessive alcohol intake, either acute or chronic, during treatment. Not recommended for use in pregnancy. Not to be used during lactation. Childn <18 yr. Elderly ≥65 yr. Metformin: Hypoglycemia could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use w/ other glucose-lowering agents (eg, sulfonylureas & insulin) or ethanol. Elderly, debilitated, or malnourished patients, & those w/ adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemia effects. Concomitant use w/ medication(s) that may affect renal function or result in significant hemodynamic change or may interfere w/ disposition of metformin eg, cationic drugs eliminated by renal tubular secretion.

Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycemia, abdominal pain.

Metformin: Decreased AUC & C_max of glyburide & furosemide. Increased plasma & blood C_max & AUC w/ furosemide. Increased plasma C_max & AUC & amount excreted in urine w/ nifedipine. Systemic exposure & risk for lactic acidosis may be increased w/ drugs that interfere w/ common renal tubular transport systems involved in the renal elimination of metformin eg, organic cationic transporter-2 [OCT2]/multidrug & toxin extrusion [MATE] inhibitors eg, ranolazine, vandetanib, dolutegravir, & cimetidine. May lead to loss of glycemic control w/ certain drugs that tend to produce hyperglycemia eg, thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OC, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers, & INH.

Antidiabetic Agents

A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Rx