Страна: Израел
Език: английски
Източник: Ministry of Health
SITAGLIPTIN AS MONOHYDRATE PHOSPHATE
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
A10BH01
FILM COATED TABLETS
SITAGLIPTIN AS MONOHYDRATE PHOSPHATE 25 MG
PER OS
Required
MERCK SHARP & DOHME CORP., USA
SITAGLIPTIN
Januvia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus.Important limitations of use:Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings.Januvia has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Januvia.
2015-02-02
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JANUVIA ® 25 MG, FILM COATED TABLETS Each film-coated tablet contains 25 mg Sitagliptin (as monohydrate phosphate) JANUVIA ® 50MG, FILM COATED TABLETS Each film-coated tablet contains 50 mg Sitagliptin (as monohydrate phosphate) JANUVIA ® 100MG, FILM COATED TABLETS Each film-coated tablet contains 100 mg Sitagliptin (as monohydrate phosphate) 1 THERAPEUTIC INDICATIONS JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. _ _ IMPORTANT LIMITATIONS OF USE JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA. _[See_ _Warnings and Precautions (5.1)._] _ _ 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSING The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. 2.2 RECOMMENDATIONS FOR USE IN RENAL IMPAIRMENT For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 m² to less than 90 mL/min/1.73 m², no dosage adjustment for JANUVIA is required. For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m² to less than 45 mL/min/1.73 m²), the dose of JANUVIA is 50 mg once daily. For patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m²) or with end- stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis. Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter. There have been postmarketing reports of worsening renal function in patients with renal imp Прочетете целия документ