Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
28 Tablets; 7 Tablets
MSD International GmbH (Puerto Rico Branch) LLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ JANUMET ® XR FILM-COATED TABLETS Sitagliptin Phosphate/ Metformin Hydrochloride (50mg/500mg, 50mg/1000mg, 100mg/1000mg) 1 WHAT IS IN THIS LEAFLET 1. What JANUMET XR is used for 2. How JANUMET XR works 3. Before you use JANUMET XR 4. How to use JANUMET XR 5. While you are using JANUMET XR 6. Side effects 7. Storage and Disposal of JANUMET XR 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT JANUMET XR IS USED FOR JANUMET is a tablet that contains two prescription medicines, sitagliptin phosphate (JANUVIA™) and metformin, which lower blood sugar. Sitagliptin, a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin, a member of the biguanide class of medicines, work together to control blood sugar levels in patients with type 2 diabetes mellitus. Type 2 diabetes is also called non-insulin- dependent diabetes mellitus, or NIDDM Your doctor has prescribed JANUMET XR, along with diet and exercise, to help lower your blood sugar. WHAT IS TYPE 2 DIABETES? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar builds up in the blood. This can lead to serious medical problems. The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, such as heart problems, kidney problems, blindness, and amputation. High blood sugar can be lowered by diet and exercise, and by certain medicines. HOW JANUMET XR WORKS • JANUMET XR lowers blood sugar levels in patients with type 2 diabetes. • JANUMET XR helps to improve the levels of insulin after a meal. • JANUMET XR helps the body respond better to the insulin it makes naturally. • JANUMET XR decreases the amount of sugar made by the body. • JANUMET XR is Baca dokumen lengkap
LOCAL PRODUCT CIRCULAR LPC-MK0431A-T-052020a JANUMET® XR (sitagliptin phosphate/metformin HCl extended-release) Film-coated Tablets I. THERAPEUTIC CLASS JANUMET XR JANUMET XR (sitagliptin phosphate/metformin HCl extended-release) combines two antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class. JANUMET XR contains sitagliptin phosphate and metformin hydrochloride. JANUMET XR tablets consist of sitagliptin and an extended-release formulation of metformin. Sitagliptin phosphate Sitagliptin phosphate is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes. The DPP-4 inhibitors are a class of agents that act as incretin enhancers. By inhibiting the DPP-4 enzyme, sitagliptin 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 2 diabetes and in normal subjects. Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations. Sitagliptin differs in chemical structure and pharmacological action from GLP-1 analogues, insulin, sulfonylureas or meglitinides, biguanides, peroxisome pr Baca dokumen lengkap