Empagliflozin Tablets 25mg (30tabs/box)

• Dossier: Ctd
• Transport Package: Free
• Specification: 25mg
• Trademark: Sinolead
• Origin: China
• Model NO.: tablets

Product Description

 

 

Basic Info.

 

Generic Name	Empagliflozin Tablets 25mg
Strength	25mg
Packing	30tabs/box
Origin	China

Component:
Empagliflozin.

Character:

This product is light yellow film coating, white or quasi-white after removing the coating.

Indications:

This product is suitable for the treatment of type 2 diabetes.
monotherapy
This product is used in combination with diet control and exercise to improve blood sugar control in patients with type 2 diabetes.
Used in combination with metformin hydrochloride
When metformin hydrochloride alone is not effective in controlling blood sugar, this product can be used in combination with metformin hydrochloride to improve blood sugar control in patients with type 2 diabetes on the basis of diet and exercise.
Used in combination with metformin hydrochloride and sulfonylureas
When the combination of metformin hydrochloride and sulfonylureas still fails to effectively control blood sugar, this product can be used in combination with metformin hydrochloride and sulfonylureas to improve blood sugar control in type 2 diabetes patients on the basis of diet and exercise.
Medication restriction
This product is not recommended for use in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
 

Usage and dosage:

Recommended dose
The recommended dose of this product is 10 mg in the morning, once daily, on an empty stomach or after eating. In patients who tolerate this product, the dose may be increased to 25 mg (see Clinical Trials).
In patients with insufficient blood volume, it is recommended to correct the insufficient blood volume before starting the use of this product (see [Precautions]).
Patients with kidney damage
Assessment of renal function is recommended prior to initiation and should be performed periodically thereafter.
Patients with eGFR below 45 mL/min/1.73 m2 should not use this product.
Patients with eGFR higher than or equal to 45 mL/min/1.73 m2 do not need to adjust the dose.
If eGFR is consistently below 45 mL/min/1.73 m2, this product should be discontinued (see [Precautions]).
Patients with liver damage
Patients with liver damage do not need to adjust the dose. Increased exposure to Englipzin in patients with severe liver damage. There is limited treatment experience in patients with severe liver damage and, therefore, it is not recommended for this population.

Matters needing attention:

Hypotension
This product can cause a decrease in blood volume. Symptomatic hypotension may occur after use of this product (see [Adverse reactions]), especially in patients with kidney damage, the elderly, patients with low systolic blood pressure, and patients receiving diuretics. Before starting the use of this product, the blood volume should be evaluated for decrease, if there is a decrease in blood volume, the volume status should be corrected. After starting treatment, the signs and symptoms of hypotension should be monitored, and monitoring should be increased in clinical situations where a decrease in blood volume is expected.

Ketoacidosis
Ketoacidosis has been reported in postmarketing surveillance of patients with type 1 and type 2 diabetes receiving sodium-glucose cotransporter-2 (SGLT2) inhibitors, including englaglitzin, which is a life-threatening and serious illness requiring emergency hospitalization. Fatal cases of ketoacidosis have been reported in patients taking this product. It is not intended for the treatment of patients with type 1 diabetes.
Patients treated with this product who develop signs and symptoms consistent with severe metabolic acidosis should be evaluated for ketoacidosis regardless of blood glucose levels. This is because even if blood sugar levels are below 250 mg/dL, this product associated ketoacidosis may be present. If ketoacidosis is suspected, this product should be discontinued, the patient evaluated, and treatment should be initiated promptly. Treatment of ketoacidosis may require insulin, fluids, and sugar replacement.