There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis. Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.Januvia has not been studied in patients with a history of pancreatitis. Swelling of the hands or legs, when Januvia is used with rosiglitazone (Avandia), another type of diabetes medication, may occur. A return to baseline levels of renal impairment has been observed with supportive treatment and discontinuation of potentially causative agents. These drugs work in the pancreas and the liver to help you increase insulin and lower your blood sugar levels.Merck’s Januvia is often used with metformin and comes in combination tablets for this purpose called Janumet (sitagliptin and metformin) and Janumet XR, an extended-released form of Janumet, also from Merck.Januvia is usually well-tolerated. The time to onset of symptoms can range from one day to years. These are not all the possible side effects of JANUVIA. Health care providers are encouraged to report any prenatal exposure to Januvia by calling the Pregnancy Registry at 1-800-986-8999.The limited available data with Januvia in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Rosiglitazone is another type of diabetes medicine. Concentrations of the active intact hormones are increased by sitagliptin, thereby increasing and prolonging the action of these hormones. Januvia® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Both treatment groups had an adjusted mean increase in body weight of 0.1 kg from baseline to Week 24. There was no increase in the incidence of tumors in any organ up to 500 mg/kg, approximately 70 times human exposure at the MRHD. Patients who were on a stable dose of metformin (≥1500 mg/day) in combination with a DPP-4 inhibitor and/or sulfonylurea but with inadequate glycemic control (A1C 7.5% to 11%) were enrolled in the study. Approximately 14% of the patients in this study were Hispanic. The recommended dose of Januvia is 100 mg once daily. Januvia can be taken with or without food.For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 mFor patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 mFor patients with severe renal impairment (eGFR less than 30 mL/min/1.73 mBecause there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter. Instruct patients to seek medical advice if blisters or erosions occur Distributed by: Merck Sharp & Dohme Corp., a subsidiary ofFor patent information: www.merck.com/product/patent/home.htmlCopyright © 2006-2019 Merck Sharp & Dohme Corp., a subsidiary of The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Patients on dual therapy with metformin ≥1500 mg/day and rosiglitazone ≥4 mg/day or with metformin ≥1500 mg/day and pioglitazone ≥30 mg/day (switched to rosiglitazone ≥4 mg/day) entered a dose-stable run-in period of 6 weeks. Patients who failed to meet specific glycemic goals during the study were treated with glipizide (or other sulfonylurea) rescue. Some people might need a higher or lower A1C goal based on their age, medications they take, or other factors. Rescue glycemic therapy was used in 5% of patients treated with Januvia 100 mg and 14% of patients treated with placebo. Overall, the 200 mg daily dose did not provide greater glycemic efficacy than the 100 mg daily dose. The fraction of sitagliptin reversibly bound to plasma proteins is low (38%).Approximately 79% of sitagliptin is excreted unchanged in the urine with metabolism being a minor pathway of elimination. Available for Android and iOS devices. The apparent terminal tElimination of sitagliptin occurs primarily via renal excretion and involves active tubular secretion. It is unclear how these findings relate to changes in glycemic control in patients with type 2 diabetes mellitus.In a randomized, placebo-controlled crossover study, 79 healthy subjects were administered a single oral dose of sitagliptin 100 mg, sitagliptin 800 mg (8 times the recommended dose), and placebo. Tell patients to report development of blisters or erosions while receiving Januvia.