Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE
ORGANON PHARMA INDONESIA TBK - Indonesia
SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE
64.25 MG /500.0 MG
TABLET SALUT SELAPUT
DUS, 4 BLISTER @ 7 TABLET SALUT SELAPUT
PATHEON PUERTO RICO, INC. - United States of America
2021-08-05
_ _ JANUMET™ 50/500, 50/1000 mg Film Coated Tablets (Sitagliptin – Metformin 50/500, 50/1000 mg) INDICATIONS AND USAGE - JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus inadequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin. - JANUMET is also indicated in combination with a sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients with type 2 DM inadequately controlled with any two of the three agents: metformin, sitagliptin, or a sulfonylurea. - JANUMET is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycemic control. When Janumet is used in combination with sulfonylurea or with insulin, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia. DOSAGE AND ADMINISTRATION RECOMMENDED DOSING The dosage of antihyperglycemic therapy with JANUMET should be individualized on the basis of the patient’ s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. When Janumet is used in combination with sulfonylurea or with insulin, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia. WARNING: LACTIC ACIDOSIS Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. The onset is often subtle, accompanied only by nonspecific such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. If acidosis is suspected, JANUMET should be discontinued and Lue koko asiakirja