Ruixin Henagliflozin Proline Tablets

1. Indications and Usage
Glycemic Control: Indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. It can be used as monotherapy or in combination with metformin.
Usage Limitation: It is not indicated for type 1 diabetes or for the treatment of diabetic ketoacidosis.
2. Dosage and Administration
Route of Administration: Oral administration.
Recommended Dosage: The recommended starting dose is 5 mg once daily, preferably in the morning. It can be taken without regard to meals. For patients who require intensified glycemic control and tolerate 5 mg once daily, the dose may be increased to 10 mg once daily.
Renal/Hepatic Impairment: No dose adjustment is required for patients with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m². It is not recommended for patients with eGFR <30 mL/min/1.73 m². No adjustment is needed for mild hepatic impairment; for moderate to severe hepatic impairment, the dose should be reduced to 5 mg once daily.
3. Mechanism of Action
SGLT2 Inhibition: Henagliflozin selectively inhibits sodium-glucose cotransporter 2 (SGLT2) in the proximal renal tubules.
Glucosuria: This inhibition prevents the reabsorption of filtered glucose, leading to increased urinary glucose excretion and a subsequent reduction in blood glucose levels.
4. Safety and Warnings
Volume Depletion: The drug may cause osmotic diuresis leading to blood volume reduction. In patients at risk, volume depletion should be corrected before initiating therapy.
Acute Kidney Injury: Monitor renal function periodically, as acute renal impairment may occur.
Genital Mycotic Infections: Increased risk of fungal infections in the genital region; patients should be instructed on proper hygiene practices.
Diabetic Ketoacidosis (DKA): Risk of DKA exists, which can occur with near-normal blood glucose levels. Discontinue the drug if DKA is suspected.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Common adverse reactions (≥2% and higher than placebo) include positive urine ketones, diabetic ketoacidosis, hyperparathyroidism, weight loss, elevated urine albumin-to-creatinine ratio, and urinary tract infections.
Clinical Research Highlights: Clinical trials have demonstrated that henagliflozin significantly reduces HbA1c and fasting plasma glucose levels compared to placebo.
6. Drug Interactions
Diuretics: Concomitant use may increase the risk of hypotension and volume depletion.
Insulin and Sulfonylureas: May increase the risk of hypoglycemia; dose reduction of insulin or sulfonylureas may be necessary.
7. Pharmaceutical Information
Chemical Composition: Active ingredient: Henagliflozin (as L-proline).
Appearance: Pink film-coated tablets.
Packaging: Available in various pack sizes.
Storage: Store at controlled room temperature; protect from moisture.