Sitagliptin Phosphate Tablets 50mg (7tabs/blister, 4blisters/box)

• Dossier: Ctd
• Transport Package: Free
• Specification: 50mg
• Trademark: Sinolead
• Origin: China
• Model NO.: tablets

Product Description

 

 

Basic Info.

 

Generic Name	Sitagliptin Phosphate Tablets 50mg
Strength	50mg
Packing	7tabs/blister,4blisters/box
Origin	China

Component:
Chemical name: 7-[(3R) -3-amino-1-oxo-4 - (2, 4, 5-trifluorophenyl) butyl]-5, 6, 7, 8-tetrahydro-3 - (trifluoromethyl) -1, 2, 4-triazolone [4, 3-a] pyrazine phosphate (1:1) monohydrate.

Character:

Light brown film coating, white or near-white after removal of coating.

Indications:

monotherapy

This product is used in combination with diet control and exercise to improve blood sugar control in patients with type 2 diabetes.

In combination with metformin

When blood glucose control is not good with metformin hydrochloride alone, it can be used in combination with metformin hydrochloride to improve blood glucose control in patients with type 2 diabetes on a diet and exercise basis.
 

Usage and dosage:

The recommended dose of this product alone or in combination with metformin is 100 mg once daily. This product may be taken with or without food.

Patients with renal insufficiency

Patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 mL/min, corresponding serum creatinine level of approximately ≤ 1.7 mg/dL for men and ≤ 1.5 mg/dL for women) do not need to adjust the dose when taking this product.

Patients with moderate renal insufficiency (creatinine clearance [CrCl] ≥ 30 to < At 50 mL/min, the corresponding serum creatinine level is approximately male > 1.7 to ≤3.0 mg/dL and female > 1.5 to ≤2.5 mg/dL) When taking this product, the dose is adjusted to 50 mg once daily.

Patients with severe renal insufficiency (creatinine clearance [CrCl] < At 30 mL/min, the corresponding serum creatinine level is approximately male > 3.0 mg/dL and female > 2.5 mg/dL) or patients with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose is adjusted to 25 mg once daily. It is not necessary to consider the duration of dialysis when taking this product.

Matters needing attention:

This product should not be used in patients with type 1 diabetes or to treat diabetic ketoacidosis.

Pancreatitis: In post-marketing experience, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotic pancreatitis, has been reported in patients taking sitagliptin (see Adverse reactions, post-marketing Experience). Because these reports are submitted spontaneously and the number of populations in which they occur is uncertain, it is generally not possible to reliably estimate their frequency or determine a causal relationship with drug exposure. Patients should be advised of the characteristic symptoms of acute pancreatitis: persistent, intense abdominal pain. There have been reports suggesting that pancreatitis symptoms disappeared after sitagliptin discontinuation. If pancreatitis is suspected, sitagliptin and other suspected medications should be discontinued.

Medication for patients with renal insufficiency: This product can be excreted through the kidney. In order to make the plasma concentration of this product similar to that of patients with normal renal function, it is recommended to reduce the dose of this product in patients with moderate and severe renal insufficiency and in patients with end-stage renal disease requiring hemodialysis or peritoneal dialysis (see Administration and Dosage, patients with renal insufficiency).