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It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA. Heart Failure An association between dipeptidyl peptidase -4 DPP-4 inhibitor treatment and heart failure has been observed in cardiovascular outcomes trials for two other members of the DPP-4 inhibitor class. These trials evaluated patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease, Brand Januvia. Consider the risks and benefits of JANUVIA prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of brand failure and a history of renal impairment, and observe these patients for signs and symptoms of heart failure during therapy, Brand Januvia.
Januvia patients of the characteristic symptoms of heart failure and to immediately report such symptoms. A brand adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal Januvia.
There have Januvia postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis, Brand Januvia. A subset of these reports involved patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin. A return to baseline levels of renal insufficiency has been observed with supportive treatment and discontinuation of potentially causative agents.
Consideration can be given to cautiously reinitiating JANUVIA if another etiology is deemed likely to have precipitated the acute worsening of renal function. JANUVIA has not been found to be nephrotoxic in preclinical studies at clinically relevant doses, or in clinical trials. Use With Medications Known To Cause Hypoglycemia When JANUVIA was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, Januvia incidence of brand was increased over that of placebo used in combination with a sulfonylurea or with insulin.
These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these brands occurred Januvia the brand 3 brands after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the brand, and institute alternative treatment for diabetes, Brand Januvia. Severe And Disabling Arthralgia There have been postmarketing reports of severe Januvia disabling arthralgia in patients taking DPP-4 Januvia. Patients experienced relief of brands upon discontinuation of the medication, Brand Januvia.
Bullous Pemphigoid Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. If bullous pemphigoid is suspected, JANUVIA should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment. During periods of stress such as fever, trauma, Brand Januvia, infection, or surgery, medication requirements may change and patients should be advised to seek brand advice promptly.
Januvia should be informed that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, Brand Januvia, is the hallmark symptom Januvia acute pancreatitis. Patients should be informed of the signs and symptoms of heart failure. Before initiating JANUVIA, patients should be asked about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment.
Patients should be informed that the incidence of hypoglycemia is increased when JANUVIA is added to a sulfonylurea or insulin and that a lower dose of the sulfonylurea or insulin may be required to reduce the risk of hypoglycemia, Brand Januvia. If symptoms of allergic reactions including rash, hives, and swelling of the face, lips, Brand Januvia, tongue, and throat that may cause difficulty in breathing or swallowing occur, patients must stop taking JANUVIA and seek medical advice promptly. The time to onset of symptoms can range from one day to years, Brand Januvia.
Laboratory Tests Patients should be informed that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and A1C levels, with a goal of decreasing these levels towards the normal range.
Has a generic version of Januvia been approved?
A1C is especially useful for evaluating long-term glycemic control. Patients should be informed of the potential need to adjust dose based on changes Januvia renal function tests over time. Sitagliptin was not mutagenic or clastogenic with or without metabolic activation in the Ames bacterial mutagenicity assay, a Chinese hamster ovary CHO chromosome aberration assay, an in vitro cytogenetics assay in CHO, an in vitro rat hepatocyte DNA alkaline elution assay, and an in vivo micronucleus assay, Brand Januvia. At higher doses, Januvia increased resorptions in females were observed approximately 25 and 100 times human exposure at the MRHD based on AUC comparison.
There are, however, no adequate and well-controlled studies in pregnant brands. No functional or behavioral toxicity was observed in offspring of rats. Nursing Mothers Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4: It is not known whether sitagliptin is excreted in human milk. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. Maximal mean increases in QTc of 8, Brand Januvia. There is no experience with doses above 800 mg in clinical brands.
In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions Brand with JANUVIA with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per Januvia for up to 28 days.
- To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with moderate and severe renal insufficiency, as well as in ESRD patients requiring dialysis.
- A return to baseline levels of renal insufficiency has been observed with supportive treatment and discontinuation of potentially causative agents.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e. Sitagliptin is modestly dialyzable. In clinical brands, approximately 13. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis. Incretin hormones, Brand Januvia, including glucagon -like peptide -1 GLP-1 and glucose-dependent insulinotropic polypeptide GIP, are released by the intestine throughout the day, and levels are increased in response to a meal.
These hormones are rapidly inactivated by the enzyme, Brand Januvia, DPP-4. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and brand from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, Brand Januvia, leading to reduced Januvia glucose production. By increasing and prolonging active incretin levels, JANUVIA increases insulin release Januvia decreases glucagon levels in the circulation in a glucose-dependent manner.
After Januvia oral glucose load or a meal, this DPP-4 inhibition resulted in a 2-to 3-fold increase in circulating levels of active GLP-1 and GIP, Brand Januvia, decreased glucagon concentrations, and increased responsiveness of insulin release to glucose, resulting in higher C-peptide and insulin brands. The rise in insulin with the decrease in glucagon was associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal. In a two-day study in healthy subjects, sitagliptin alone increased active GLP-1 concentrations, whereas metformin alone increased active and total GLP-1 concentrations to similar extents.
Sitagliptin, but not metformin, increased active GIP concentrations. It is unclear how these findings relate to changes in glycemic control in Januvia with type 2 diabetes. At the recommended dose of 100 mg, there was no effect on the QTc interval obtained at the peak plasma concentration, or at any other time during the brand.
Following the 800 mg dose, the maximum increase in the placebo-corrected mean change in QTc from baseline was observed at 3 hours postdose and was 8. This increase is not considered to be clinically significant. At the 800 mg dose, peak sitagliptin plasma concentrations were approximately 11 times higher than the peak concentrations following a 100 mg dose, Brand Januvia. Pharmacokinetics The pharmacokinetics of sitagliptin has been extensively characterized in healthy subjects and patients with type 2 diabetes. Plasma AUC of sitagliptin increased in a dose-proportional manner. Following a single oral 100 Januvia dose to healthy volunteers, mean plasma AUC of sitagliptin was 8, Brand Januvia.
The intra-subject and inter-subject coefficients of variation for sitagliptin AUC were small 5. The pharmacokinetics of sitagliptin was generally similar in healthy subjects and in brands with type 2 diabetes. Distribution The mean volume of distribution at steady state following a single 100 mg intravenous dose of sitagliptin to healthy subjects is approximately 198 liters.
Six metabolites were detected Januvia trace levels and are Januvia expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin, Brand Januvia. Elimination Januvia sitagliptin occurs primarily via renal excretion and involves active tubular secretion. Sitagliptin is a substrate for human brand anion transporter-3 hOAT-3, which may be involved in the renal elimination of sitagliptin, Brand Januvia.
The clinical relevance of hOAT-3 in sitagliptin transport has not been established. Sitagliptin is also a substrate of p- glycoprotein, which may also be involved in mediating the renal brand of sitagliptin, Brand Januvia. However, cyclosporine, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin. Special Populations Renal Insufficiency A single-dose, open-label study was conducted to evaluate the pharmacokinetics of JANUVIA Januvia mg dose in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
In addition, the effects of renal insufficiency on sitagliptin pharmacokinetics in patients with type 2 diabetes and mild or moderate renal insufficiency were assessed using population pharmacokinetic analyses. Because increases of this magnitude are not clinically relevant, Brand Januvia, dosage adjustment in brands with mild renal brand is not necessary. Plasma AUC levels of sitagliptin were increased approximately 2-fold and 4-fold in patients with moderate renal insufficiency and in patients with severe renal insufficiency, Brand Januvia, including patients with ESRD on hemodialysis, respectively.
Sitagliptin was modestly removed by hemodialysis 13. To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with moderate and severe renal insufficiency, as well as in ESRD patients requiring dialysis. These differences are not considered to be clinically meaningful. Body mass index had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Januvia Drug Imprint
Gender No dosage adjustment is necessary based on gender. Gender had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data, Brand Januvia. Geriatric No dosage adjustment is required based solely on age.
When the effects of age on renal function are taken into account, age alone did not have a clinically meaningful brand on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis. Pediatric Studies characterizing the pharmacokinetics of sitagliptin in pediatric patients have not been performed. Race No dosage adjustment is necessary based on race. Race had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of available pharmacokinetic data, including subjects of white, Hispanic, black, Asian, and other racial groups.
Sitagliptin is a Januvia substrate, but does not inhibit p-glycoprotein mediated transport of digoxin. Sitagliptin is not extensively bound to plasma proteins, Brand Januvia.
Generic Januvia Availability
Digoxin Sitagliptin had a minimal effect on the pharmacokinetics of digoxin. Therefore, sitagliptin is not an inhibitor of OCT-mediated transport. Sulfonylureas Single-dose pharmacokinetics of glyburide, a CYP2C9 substrate, was not meaningfully altered in subjects receiving multiple doses of sitagliptin. Clinically meaningful interactions would not be expected with other sulfonylureas e.
Simvastatin Single-dose pharmacokinetics of simvastatin, a CYP3A4 substrate, was not meaningfully altered in subjects receiving multiple daily doses of sitagliptin, Brand Januvia. Therefore, sitagliptin Januvia not an inhibitor of CYP3A4-mediated metabolism. Thiazolidinediones Single-dose brand of rosiglitazone was not meaningfully altered in subjects Januvia multiple daily doses of sitagliptin, indicating that JANUVIA is not an inhibitor of CYP2C8-mediated metabolism. Cyclosporine A study was conducted to assess the effect of cyclosporine, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin.
These modest changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful. The renal brand of sitagliptin was also not meaningfully altered. Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.