Huiyoujing Ganagliflozin 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, either as monotherapy or in combination with metformin.
2. Dosage and Administration
Route of Administration: Oral administration.
Recommended Dosage: The recommended starting dose is 5 mg once daily in the morning, regardless of meals. The dose may be increased to 10 mg once daily based on clinical response and tolerability.
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. For mild hepatic impairment, no adjustment is needed; use caution in moderate to severe hepatic impairment.
Hydration: Volume depletion should be corrected before initiating therapy in patients at risk.
3. Mechanism of Action
SGLT2 Inhibition: Ganagliflozin 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: May cause osmotic diuresis leading to blood volume reduction and symptomatic hypotension, especially in the elderly, those with renal impairment, or patients taking diuretics.
Acute Kidney Injury: Monitor renal function, as acute renal impairment may occur, particularly in patients with volume depletion.
Genital Mycotic Infections: Increased risk of fungal infections in the genital region; instruct patients on proper hygiene.
Diabetic Ketoacidosis (DKA): Risk of DKA, which can occur with near-normal blood glucose levels. Discontinue if DKA is suspected.
Hypersensitivity: Severe allergic reactions, including angioedema and Stevens-Johnson syndrome, have been reported.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Urinary tract infections, increased urination, positive urine ketones, diabetic ketoacidosis, and increased parathyroid hormone.
Clinical Research Highlights: Clinical trials have demonstrated that ganagliflozin significantly reduces HbA1c and fasting plasma glucose levels compared to placebo, with a low risk of weight gain.
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.
CYP3A4 Inducers: Strong CYP3A4 inducers (e.g., rifampin) may decrease ganagliflozin efficacy; dose adjustment may be considered.
7. Pharmaceutical Information
Chemical Composition: Active ingredient: Ganagliflozin (as L-proline).
Appearance: Pink film-coated tablets.
Packaging: Available in various pack sizes (e.g., 10 or 30 tablets per pack).
Storage: Store at controlled room temperature (15°C to 30°C); protect from moisture.