【藥品庫存】 藥品安全警訊 (藥品回收)：院內採購的 Januvia 錠劑 100 mg 有一批號為【U011910】被驗出含有亞硝胺類不純物 (MDMA)，即日起回收，更新日期：2022/12/27。

糖尿病 (DPP4I) Type 2 diabetes mellitus

Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, which protects glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide (GLP-1) from inactivation, thereby enhancing their actions; this increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.

Absorption Tmax, oral: 1 to 4 hours. Bioavailability, oral: 87%. Effects of food: No effect. Distribution
Protein binding: 38%. Vd: 198 L. Metabolism
Substrate of CYP3A4 and CYP2C8 (minimal metabolism). Substrate of P-gp, however no reduction in renal clearance seen with cyclosporin, a P-gp inhibitor. Substrate of human organic anion transporter-3 (hOAT-3). Excretion
Renal clearance: 350 to 357 mL/min. Renal excretion: 79% to 90.2% unchanged. Fecal excretion: 13%. Dialyzable: Yes (hemodialysis), 13.5% removed. Elimination Half Life 11.3 to 12.4 hours.

Serious hypersensitivity reaction to sitagliptin such as angioedema or anaphylaxis

Fetal risk cannot be ruled out.

Infant risk cannot be ruled out.

Endocrine & metabolic: Hypoglycemia (1%)
Respiratory: Nasopharyngitis (5%)
Gastrointestinal: Diarrhea, nausea
Renal: Increased serum creatinine

Type 2 diabetes mellitus 100 mg orally once daily with or without food; when administered with a sulfonylurea or insulin, a lower dose of sulfonylurea or insulin may be required

The safety and efficacy of sitagliptin phosphate have not been established in pediatric patients

Estimated GFR, 45 mL/min/1.73 m(2) or greater: No adjustment is required.
Moderate impairment (estimated GFR 30 to less than 45 mL/min/1.73 m(2)): 50 mg orally once daily.
Severe impairment (estimated GFR less than 30 mL/min/1.73 m(2)): 25 mg orally once daily.

Mild to moderate impairment (Child-Pugh classes A and B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
(from uptodate)

Sitagliptin phosphate may be taken with or without food.