When the effects of age on renal function are taken into account, age alone did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis. The recommended dose of JANUVIA is 100 mg once daily. Patients on any oral antihyperglycemic agent in monotherapy (N=212) or on a PPARγ agent in combination therapy (N=106) or not on an antihyperglycemic agent (off therapy for at least 8 weeks, N=34) were switched to monotherapy with pioglitazone (at a dose of 30-45 mg per day), and completed a run-in period of approximately 12 weeks in duration. JANUVIA (jah-NEW-vee-ah) is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type 2 diabetes. 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. After the run-in period, patients with inadequate glycemic control (A1C 7.5% to 11%) were randomized to the addition of either 100 mg of JANUVIA or placebo, administered once daily. They are supplied as follows:NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). At Week 54, mean reduction in A1C was -1.0% for patients treated with JANUVIA and -0.3% for patients treated with placebo in an analysis based on the intent-to-treat population. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. JANUVIA should not be used in patients with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine). 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. For treatment of depression, doses of up to 200 mg daily and, occasionally, up to 300 mg daily have been used in severely depressed patients in hospital only. Many people using Januvia do not have serious side effects. This dose results in exposures approximately 60 times the human exposure at the maximum recommended daily adult human dose (MRHD) of 100 mg/day based on AUC comparisons. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Disease-Associated Maternal and/or Embryo/Fetal RiskSitagliptin and Metformin hydrochloride CoadministrationEffects of Age, Body Mass Index (BMI), Gender, and RaceActive-Controlled Study vs Glipizide in Combination with MetforminAdd-on Combination Therapy with Metformin and RosiglitazoneAdd-on Combination Therapy with Glimepiride, with or without MetforminAdd-on Combination Therapy with Insulin (with or without Metformin)Maintenance of Januvia During Initiation and Titration of Insulin GlargineWhat is the most important information I should know about Januvia?Serious side effects can happen in people taking Januvia,Inflammation of the pancreas (pancreatitis) which may be severe and lead to deathWhat should I tell my doctor before taking Januvia?Keep Januvia and all medicines out of the reach of children.We comply with the HONcode standard for trustworthy health information - It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate.Each film-coated tablet of Januvia contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. Because sitagliptin is substantially excreted by the kidney, and because aging can be associated with reduced renal function, renal function should be assessed more frequently in elderly patients Sitagliptin is excreted by the kidney, and sitagliptin exposure is increased in patients with renal impairment. In addition, an active (glipizide)-controlled study of 52-weeks duration was conducted in 1172 patients with type 2 diabetes who had inadequate glycemic control on metformin.In patients with type 2 diabetes, treatment with JANUVIA produced clinically significant improvements in hemoglobin A1C, fasting plasma glucose (FPG) and 2-hour post-prandial glucose (PPG) compared to placebo.A total of 1262 patients with type 2 diabetes participated in two double-blind, placebo-controlled studies, one of 18-week and another of 24-week duration, to evaluate the efficacy and safety of JANUVIA monotherapy.