Maximum Recommended Dose of Gliclazide
The maximum recommended daily dose of gliclazide depends on the formulation: 320 mg/day for immediate-release (IR) gliclazide and 120 mg/day for modified-release (MR) gliclazide. 1, 2
Formulation-Specific Maximum Doses
Immediate-Release (IR) Gliclazide
- The maximum daily dose is 320 mg/day, with an initial starting dose of 40-80 mg daily 2
- Doses exceeding 80 mg should be divided into two doses throughout the day rather than given as a single dose 2
- Clinical studies have confirmed the use of gliclazide at doses ranging from 40 to 320 mg per day with good tolerability 3, 4
Modified-Release (MR) Gliclazide
- The maximum daily dose is 120 mg/day, given as a once-daily dose 1
- The starting dose is typically one 60 mg tablet daily, which can be titrated upward based on glycemic response 1
- The MR formulation provides 24-hour glycemic control with once-daily dosing, eliminating the need for divided doses 5
Important Dosing Considerations
Renal Impairment
- For patients with mild to moderate renal impairment, no specific dose adjustment is required for gliclazide 2
- For patients with GFR <30 mL/min/1.73 m², gliclazide may need dose reduction but can still be used with caution, as it is primarily metabolized by the liver 1
Clinical Efficacy at Maximum Doses
- Escalating gliclazide beyond 15-20 mg daily (for glipizide, a related sulfonylurea) rarely provides meaningful additional benefit and increases hypoglycemia risk 6
- When comparing uptitration of gliclazide from 160 mg to 320 mg versus adding another agent, the uptitration provided modest additional glycemic benefit but with increased hypoglycemia risk 4
Common Pitfall
- Avoid continuing to escalate gliclazide doses to maximum levels if glycemic targets are not met at moderate doses—consider switching to insulin therapy or adding agents with cardiovascular and renal benefits (SGLT2 inhibitors or GLP-1 receptor agonists) rather than pushing to maximum sulfonylurea doses 6, 2