Sitazid50 mg

Monotherapy and Combination Therapy: Sitazid 50 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Limitations of Use: Sitazid 50 mg 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. Sitazid 50 mg has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitazid 50 mg.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

The DPP-4 inhibitors are a class of agents that act as incretin enhancers. By inhibiting the DPP-4 enzyme, Sitazid 50 mg increases the levels of two known active incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. This mechanism is unlike the mechanism seen with sulfonylureas; sulfonylureas cause insulin release even when glucose levels are low, which can lead to sulfonylurea-induced hypoglycemia in patients with type ll diabetes and in normal subjects. Sitazid 50 mg demonstrates high selectivity for DPP-4 and does not inhibit closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.

The recommended dose of Sitazid 50 mg is 100 mg once daily as monotherapy or as combination therapy with Metformin, a sulfonylurea, a thiazolidinedione, or Metformin plus a sulfonylurea. Sitazid 50 mg can be taken with or without food.Elderly: No dosage adjustment is required based solely on age. The drug is excreted by the kidney. As elderly patients are more likely to have decreased renal function, caution should be taken in dose selection in the elderly.Pediatric use: There is no data on use of Sitazid 50 mg in patients younger than 18 years of age and therefore not recommended.

The recommended dose of Sitazid 50 mg is 50 mg twice a day and 100 mg once daily. Sitazid 50 mg can be taken with or without food.

Effects of Sitazid 50 mg on other Drugs: Sitazid 50 mg did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptive.Digoxin: Sitazid 50 mg slightly increases the mean of Digoxin concentration. However, no dose adjustment of either drug is required.

History of a serious hypersensitivity reaction to Sitazid 50 mg, such as anaphylaxis or angioedema.

The most common adverse reactions include headache, upper respiratory tract infection and nasopharyngitis. Hypoglycemia may occur in patients treated with the combination to Sitazid 50 mg and sulfonylurea and add on to insulin.

Pregnancy: Pregnancy Category B. Safety of Sitazid 50 mg in pregnant women has not been established. Sitazid 50 mg should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.Nursing Mothers: It is not known whether Sitazid 50 mg is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sitazid 50 mg is administered to a nursing woman.

If pancreatitis is suspected, Sitazid 50 mg should promptly be discontinued and appropriate management should be initiated.Use in Patients with Renal Insufficiency: Dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis.Use with medications known to cause Hypoglycemia: When Sitazid 50 mg is used in combination therapy dosage adjustment of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.Hypersensitivity Reactions: There have been post-marketing reports of serious hypersensitivity reactions in patients treated with Sitazid 50 mg. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, discontinue Sitazid 50 mg, assess for other potential causes for the event, and institute alternative treatment for diabetes.

During controlled clinical trials in healthy subjects, single doses of up to 800 mg Sitazid 50 mg were administered. Maximal mean increases in QTc of 8.0 msec were observed in one study at a dose of 800 mg Sitazid 50 mg, a mean effect that is not considered clinically important. There is no experience with doses above 800 mg in clinical studies. In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with Sitazid 50 mg with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for up to 28 days. In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient's clinical status. Sitazid 50 mg is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if Sitazid 50 mg is dialyzable by peritoneal dialysis.

Store below 25°C in a dry place away from light. Keep the medicines in a safe place, out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician

Renal Insufficiency- Mild renal insufficiency (creatinine clearance [CrCl] >50 mL/min, approximately corresponding to serum creatinine levels of >1.7 mg/dL in men and >1.5 mg/dL in women), no dosage adjustment for Sitazid 50 mg is required. Moderate renal insufficiency (CrCl >30 to 1.7 to 1.5 to Severe renal insufficiency (CrCl 3.0 mg/dL in men and > 2.5 mg/dL in women) or with end -stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Sitazid 50 mg is 25 mg once daily. Sitazid 50 mg may be administered without regard to the timing of hemodialysis. Concomitant Use with a Sulfonylurea- When Sitazid 50 mg is used in combination with a sulfonylurea, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycemia. Hepatic Insufficiency: No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency. Sitazid 50 mg has not been studied in patients with severe hepatic insufficiency.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Sitazid 50 mg is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by Sitazid 50 mg, thereby increasing and prolonging the action of these hormones. Incretin hormones, 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, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, Sitazid 50 mg increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner. Sitazid 50 mg demonstrates selectivity for DPP-4 and does not inhibit DPP-8 or DPP-9 activity in vitro at concentrations approximating those from therapeutic doses.

Pregnancy Category B. Reproduction studies have been performed in rats and rabbits. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Sitazid 50 mg is secreted in the milk of lactating rats at milk to plasma ratio of 4:1. It is not known whether Sitazid 50 mg is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sitazid 50 mg is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of Sitazid 50 mg in pediatric patients under 18 years of age have not been established.Geriatric Use: This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly, and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter.For patients with mild renal insufciency: (CrCl <50 ml/min or serum creatinine levels of <1.7 mg/DL in men and <1.5 mg/DL in women), no dosage adjustment for Sitazid 50 mg is required.For patients with moderate renal insufciency: (CrCl <30 to <50 mL/min, or serum creatinine levels of >1.7 to <3.0 mg/dL in men and >1.5 to <2.5 mg/dL in women), the dose of Sitazid 50 mg is 50 mg once daily.For patients with severe renal insufficiency: (CrCl <30 mL/min or serum creatinine levels of >3.0 mg/dL in men and 2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Sitazid 50 mg is 25 mg once daily. Sitazid 50 mg may be administered without regard to the limiting of hemodialysis.