Jardiance Empagliflozin Tablets

Brand Name: 欧唐静®(Jardiance®)
Generic Name: Empagliflozin
Strength: 10 mg per tablet (common package specification: 10 tablets per box)
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG
Marketing Authorization Holder: Boehringer Ingelheim International GmbH
Approval Date in China: September 27, 2017
Registration Number: 国药准字HJ20170351
Storage: Keep tightly sealed, store at room temperature in dry shaded areas, avoid high heat and humidity; keep out of children’s reach, follow the full storage specifications noted on the package insert.

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1. Indications and Usage
Type 2 Diabetes: Empagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Combination Therapy: It may be used alone or in combination with metformin, sulfonylureas, or insulin.
2. Dosage and Administration
Standard Dosage: The recommended dose is 10 mg once daily in the morning, with or without food. The dose may be increased to 25 mg once daily if further glycemic control is needed and the drug is tolerated.
Renal Impairment: Initiation is not recommended if eGFR is persistently below 45 mL/min/1.73 m².
Administration: Take once daily, preferably in the morning.
3. Mechanism of Action
SGLT2 Inhibitor: Empagliflozin is a selective inhibitor of sodium-glucose cotransporter 2 (SGLT2) in the kidney.
Renal Effects: It inhibits the reabsorption of filtered glucose in the proximal tubules, leading to increased urinary glucose excretion and subsequent reduction in blood glucose levels.
4. Safety and Warnings
Hypoglycemia: The risk increases when combined with insulin or sulfonylureas.
Urinary Tract Infections: Increased risk of genital mycotic and urinary tract infections due to glycosuria.
Volume Depletion: May cause intravascular volume contraction, especially in elderly patients or those on diuretics.
Acute Kidney Injury: Acute kidney injury has been reported; renal function should be monitored.
DKA: euglycemic diabetic ketoacidosis (DKA) has been reported, even with near-normal blood glucose levels.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include urinary tract infections, genital mycotic infections, back pain, nausea, and increased urination.
Clinical Research: Clinical trials demonstrate that empagliflozin significantly reduces fasting plasma glucose, postprandial glucose, and HbA1c levels.
6. Drug Interactions
Insulin/Sulfonylureas: May potentiate hypoglycemic effects; dose reduction of insulin or sulfonylureas may be required.
Diuretics: May increase the risk of volume depletion.
SGLT2 Inhibitors: Concomitant use with other SGLT2 inhibitors is not recommended.
7. Pharmaceutical Information
Active Ingredient: Empagliflozin.
Excipients: Lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate, and film-coating agents.
Appearance: Film-coated tablets.
Storage: Store in a tight container, protected from moisture.

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