Nazione: Indonesia
Lingua: indonesiano
Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SITAGLIPTIN PHOSPHATE
ORGANON PHARMA INDONESIA TBK - Indonesia
SITAGLIPTIN PHOSPHATE
128.5 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
MERCK SHARP & DOHME LTD. - United Kingdom
2021-07-17
JANUVIA™ 25/50/100 MG TABLETS (Sitagliptin 25/50/100 mg) INDICATIONS AND USAGE • MONOTHERAPY JANUVIA TM is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. • COMBINATION WITH METFORMIN OR PPAR AGONIST Januvia is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with Metformin or a PPAR agonist (i.e. thiazolidinediones) when the single agent alone, with diet and exercise, does not provide adequate glycemic control. • COMBINATION WITH METFORMIN AND SULFONYLUREA Januvia is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycemic control. • COMBINATION WITH INSULIN Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycemic control. When Januvia is used in combination with a sulfonylurea or with insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycemia. DOSAGE AND ADMINISTRATION RECOMMENDED DOSING The recommended dose of JANUVIA is 100 mg once daily as monotherapy or as combination therapy with metformin or a PPARγ agonist (e.g., thiazolidinediones), metformin and sulfonylurea, stable dose of insulin (with or without metformin). JANUVIA can be taken with or without food. When used in combination with metformin or a PPAR agonist, the dose of metformin or PPAR agonist should be maintained, and Januvia administered concomitantly. When Januvia is used in combination with a sulfonylurea or with insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of DISETUJUI OLEH BPOM : 29/10/2021 ID : EREG100373VR12100471 EREG100373VR12100477 EREG100373VR12100478 hypoglycaemia PATIENTS WITH RENAL IMPAIRMENT Because there is a dosage adjustment based upon Leggi il documento completo