JANUVIA sitagliptin tablet film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z)

Commercializzato da:

Avera McKennan Hospital

INN (Nome Internazionale):

SITAGLIPTIN PHOSPHATE

Composizione:

SITAGLIPTIN 25 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

JANUVIA- SITAGLIPTIN TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JANUVIA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR JANUVIA.
JANUVIA (SITAGLIPTIN) TABLETS
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Warnings and Precautions
Bullous Pemphigoid (5.6)
01/2017
INDICATIONS AND USAGE
JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an
adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus. (1.1)
Important Limitations of Use:
JANUVIA should not be used in patients with type 1 diabetes or for the
treatment of diabetic ketoacidosis. (1.2)
JANUVIA has not been studied in patients with a history of
pancreatitis. (1.2, 5.1)
DOSAGE AND ADMINISTRATION
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be
taken with or without food. (2.1)
Dosage adjustment is recommended for patients with moderate or severe
renal insufficiency or end-stage renal disease.
(2.2)
Dosage Adjustment in Patients With Moderate, Severe and End Stage
Renal Disease (ESRD) (2.2)
50 mg once daily
25 mg once daily
Moderate
CrCl ≥30 to <50 mL/min
~Serum Cr levels [mg/dL]
Men: >1.7– ≤3.0;
Women: >1.5– ≤2.5
Severe and ESRD
CrCl <30 mL/min
~Serum Cr levels [mg/dL]
Men: >3.0;
Women: >2.5;
or on dialysis
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 50 mg, and 25 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to sitagliptin, such as
anaphylaxis or angioedema (5.4, 6.2)
WARNINGS AND PRECAUTIONS
There have been postmarketing reports of acute pancreatitis, including
fatal and non-fatal hemorrhagic or necrotizing
pancreatitis. If pancreatitis is suspected, promptly discontinue
JANUVIA. (5.1)
There have been postmarketing reports of acute renal failure,
sometimes requiring dialysis. Dosage adjustment is
recommended in patients with moderate or severe renal insufficiency
and in patients with ESRD. Assessment of renal
function i