Država: Bangladeš
Jezik: angleščina
Source: DGDA (Directorate General of Drug Administration)
Sitagliptin
Radiant Pharmaceuticals Ltd.
Sitagliptin
50 mg
Tablet
RADIGLIP TM Sitagliptin USP PMR5398 Version: 01 TM = Trade Mark Manufactured by RADIANT PHARMACEUTICALS LIMITED B-34 & 46, BSCIC Industrial Estate Tongi, Gazipur, Bangladesh COMPOSITION: Radiglip TM 50 mg Tablet: Each film coated tablet contains Sitagliptin 50 mg as Sitagliptin Phosphate USP. PHARMACOLOGY: Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin 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, Sitagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner. INDICATIONS: Radiglip TM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Radiglip TM is indicated as monotherapy and also indicated for use in combination with Metformin, Sulfonylurea or Thiazolidinediones when diet, exercise and the single agent does not provide adequate glycemic control. DOSAGE & ADMINISTRATION: • The recommended dose of Radiglip TM is 100 mg once daily. Radiglip TM can be taken with or without food. • For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 mL/min) no dosage adjustment for Radiglip TM is required. • For patients with moderate renal insufficiency (creati Preberite celoten dokument