JANUVIA 50 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

SITAGLIPTIN AS MONOHYDRATE PHOSPHATE

Dostupné z:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC kód:

A10BH01

Forma lieku:

FILM COATED TABLETS

Zloženie:

SITAGLIPTIN AS MONOHYDRATE PHOSPHATE 50 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

MERCK SHARP & DOHME LLC, USA

Terapeutické oblasti:

SITAGLIPTIN

Terapeutické indikácie:

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.

Dátum Autorizácia:

2015-02-02

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Súhrn charakteristických

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