Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SITAGLIPTIN
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
SITAGLIPTIN
28Tablet Tablets
MERCK SHARP & DOHME LTD
_ Consumer Medication Information Leaflet (RiMUP)_ JANUVIA ® TABLET Sitagliptin Phosphate (25mg, 50mg, 100mg) 1 WHAT IS IN THIS LEAFLET 1. What _JANUVIA_ is taken for 2. How _JANUVIA_ works 3. Before you take _JANUVIA_ 4. How to take _JANUVIA_ 5. While you are taking JANUVIA 6. Side effects 7. Storage and disposal of JANUVIA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision Please read this information carefully before you start to take your medicine, even if you have just refilled your prescription. Some of the information may have changed. Remember that your doctor has prescribed this medicine only for you. Never give it to anyone else. WHAT JANUVIA IS TAKEN FOR JANUVIA (sitagliptin phosphate, MSD) is a tablet that contains 25, 50, or 100 mg of sitagliptin _ _ as the active ingredient. • JANUVIA helps to improve the levels of insulin after a meal. • JANUVIA decreases the amount of sugar made by the body. • JANUVIA works when blood sugar is high, especially after a meal. This is when the body needs the greatest amount of help in lowering blood sugar. JANUVIA also lowers blood sugar between meals. • JANUVIA by itself is unlikely to cause low blood sugar (hypoglycemia) because it does not work when your blood sugar is low. HOW JANUVIA WORKS JANUVIA is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM. WHY HAS MY DOCTOR PRESCRIBED JANUVIA? Your doctor has prescribed JANUVIA to help lower your blood sugar, which is too high because of your type 2 diabetes. JANUVIA can be used alone or in combination with certain other medicines that lower blood sugar, along with a recommended diet and exercise program. 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 Прочитайте повний документ
LOCAL PRODUCT CIRCULAR LPC-MK0431-T-052020B Tablet JANUVIA® (sitagliptin phosphate) I. THERAPEUTIC CLASS JANUVIA * (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 proliferator-activated receptor gamma (PPAR γ ) agonists, alpha-glucosidase inhibitors, and amylin analogues. II. COMPOSITION _IIA. ACTIVE INGREDIENTS _ 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. III. CLINICAL PHARMACOLOGY _IIIA. MECHANISM OF ACTION_ JANUVIA is a member of a class of oral anti-hyperglycemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors, which improve glycemic control in patients with type 2 diabetes by en Прочитайте повний документ