Fulairui Canagliflozin Tablets

1. Indications and Usage
Glycemic Control: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Restrictions: It is not recommended for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
2. Dosage and Administration
Starting Dose: The recommended starting dose is 100 mg once daily, taken before the first meal of the day.
Titration: In patients who tolerate 100 mg once daily and require additional glycemic control, the dose may be increased to 300 mg once daily, provided the estimated glomerular filtration rate (eGFR) is ≥ 60 mL/min/1.73 m².
Renal Adjustment: For patients with an eGFR of 45 to 59 mL/min/1.73 m², the dose should be limited to 100 mg once daily. Use is not recommended if eGFR is persistently below 45 mL/min/1.73 m².
3. Mechanism of Action
SGLT2 Inhibition: Canagliflozin is a selective inhibitor of sodium-glucose cotransporter 2 (SGLT2) in the kidney.
Glucose Excretion: By inhibiting SGLT2, it reduces glucose reabsorption in the proximal tubule, thereby increasing urinary glucose excretion and lowering blood glucose levels.
4. Safety and Warnings
Hypovolemia: May cause symptoms of hypovolemia, particularly in the elderly or those on diuretics. Assess volume status before initiating.
Lower Limb Amputation: An increased incidence of lower limb amputations, primarily involving the toe or foot, has been observed.
Severe Renal Impairment: Use is not recommended in patients with an eGFR persistently below 45 mL/min/1.73 m² due to loss of efficacy.
Genital Infections: Increased risk of genital mycotic infections.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Urination urgency, increased urination frequency, nocturia, polyuria, and genital mycotic infections.
Hypoglycemia: Low risk as monotherapy, but the risk increases when used with insulin or sulfonylureas.
Other Adverse Effects: Hypotension, hyperkalemia, and increased LDL-C levels have been reported.
Clinical Findings: Clinical trials demonstrated significant reductions in HbA1c and body weight compared to placebo.
6. Drug Interactions
UGT Inducers: Strong inducers of UGT (e.g., rifampin) may reduce canagliflozin exposure.
Digoxin: Concomitant use with digoxin may increase digoxin exposure; monitoring is recommended.
Hypoglycemic Agents: Concomitant use with insulin or sulfonylureas increases the risk of hypoglycemia.
Diuretics: Concomitant use may increase the risk of hypovolemia and symptomatic hypotension.
7. Pharmaceutical Information
Active Ingredient: Canagliflozin.
Strengths: Typically available as 100 mg and 300 mg tablets.
Appearance: White to off-white tablets.
Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).