GMP Certified / Empagliflozin Tablets 25mg

• Customization: Available
• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Model NO.: Tablet
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 25mg
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

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

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Empagliflozin Tablets 25mg

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.

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.
In many post-marketing reports, especially in patients with type 1 diabetes, ketoacidosis may not be detected in time and treatment may be delayed because blood sugar levels are lower than would normally be expected for diabetic ketoacidosis (usually below 250 mg/dL). The signs and symptoms of the disease are consistent with dehydration and severe metabolic acidosis, including nausea, vomiting, abdominal pain, general weakness, and shortness of breath. In some, but not all, cases, predisposition factors for ketoacidosis were identified, such as reduced insulin dose, acute febrile illness, reduced caloric intake due to illness or surgery, pancreatic disease suggestive of insulin deficiency (e.g., type 1 diabetes, pancreatitis, or a history of pancreatic surgery), and alcohol abuse.
Possible predisposition factors for ketoacidosis in the patient's history should be considered before starting treatment with this product, including insufficient secretion of pancreatic insulin for any reason, caloric restriction, and alcohol abuse. Monitoring for ketoacidosis and temporary discontinuation of ketoacidosis should be considered in patients treated with this product for clinical conditions of known susceptibility to ketoacidosis (e.g., prolonged fasting due to acute illness or surgery).
Acute renal injury and renal impairment
This product can cause a decrease in blood volume and may cause kidney function impairment (see [Adverse reactions]). Acute kidney injury has been reported in patients with SGLT2 inhibitors (including englaglitzin) after marketing, with some requiring hospitalization and dialysis. Some reported patients under 65 years of age.
Factors that may predisplace patients for acute kidney injury, including hypovolemia, chronic renal insufficiency, congestive heart failure, and concomitant medications (diuretics, ACE inhibitors, ARBs, NSaids), should be considered before initiation. If oral intake is reduced (e.g. acute illness or fasting) or there is fluid loss (e.g. gastrointestinal illness or heat exposure), consider temporarily disusing the product; Patients were monitored for signs and symptoms of acute kidney injury. If acute kidney injury occurs, discontinue this product immediately and start treatment.
It can increase serum creatinine and decrease eGFR. Patients with low blood volume may be more prone to these changes. Abnormal kidney function may occur after beginning use of this product (see [Adverse reactions]). Renal function should be evaluated prior to initiation and monitored regularly thereafter. More frequent renal function monitoring is recommended for patients with eGFR less than 60 mL/min/1.73 m2. When the eGFR is less than 45 mL/min/1.73 m2, it is not recommended to use this product, and patients with eGFR less than 30 mL/min/1.73 m2 should not use this product (see [Usage and dosage], [contraindication]).
Urinary sepsis and pyelonephritis
Postmarketing surveillance of SGLT2 inhibitors, including englaglitzin, has reported patients with severe urinary tract infections, including urinary sepsis and pyelonephritis requiring hospitalization. Treatment with SGLT2 inhibitors increases the risk of urinary tract infections. If there are indications, patients should be evaluated for signs and symptoms of urinary tract infection, and timely treatment should be given (see [Adverse reactions]).
Combined insulin and insulin secretagogue associated hypoglycemia
Insulin and insulin secretagogues are known to cause hypoglycemia. When used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin, there is an increased risk of hypoglycemia (see Adverse Reactions). Therefore, when used in combination with this product, it may be necessary to lower the dose of insulin secretagogues or insulin to reduce the risk of hypoglycemia.
Genital fungal infection
This product may increase the risk of genital fungal infection (see [Adverse Reactions]). Patients with a history of chronic or recurrent genital fungal infections are more likely to develop fungal genital infections. Monitor and treat as needed.
Elevated low-density lipoprotein cholesterol (LDL-C)
An increase in LDL-C may occur after treatment with this product (see [Adverse reactions]). Monitor and treat as needed.


Storage:
Seal and store no more than 25C.