What is the maximum dose of gliclazide (sulfonylurea) 60mg tablet per day?

Maximum Dose of Gliclazide 60mg Tablet

The maximum daily dose of gliclazide 60mg modified-release (MR) tablets is 120mg per day, which equals two tablets daily. 1

Dosing Guidelines for Gliclazide MR 60mg

• Initial dosing typically starts with one 60mg tablet daily, which can be increased based on glycemic response 2, 1
• For patients requiring additional glycemic control, dosage can be increased to 1½ tablets (90mg) as an intermediate step before reaching the maximum dose 1
• The maximum recommended dose is 120mg (two 60mg tablets) daily 1, 3
• Gliclazide MR should be administered as a once-daily dose, preferably before the first meal of the day 2, 4

Efficacy and Dose-Response Relationship

• Clinical studies show that increasing the dose of gliclazide MR correlates with improved glycemic control 1:
  • One tablet (60mg): Mean fasting plasma glucose reduction of 48.7 mg/dl 1
  • One and a half tablets (90mg): Mean fasting plasma glucose reduction of 71.3 mg/dl 1
  • Two tablets (120mg): Mean fasting plasma glucose reduction of 86.3 mg/dl 1
• At the maximum dose of 120mg daily, approximately 77.5% of patients achieved target glycemic control 1

Special Considerations for Renal Impairment

• Unlike some sulfonylureas that require significant dose adjustments in renal impairment, gliclazide is primarily metabolized by the liver 2
• For patients with GFR <30 ml/min/1.73 m², gliclazide may need dose reduction but can still be used with caution 2
• This contrasts with glyburide/glibenclamide which should be avoided in renal impairment 2

Safety Profile

• Hypoglycemia risk with gliclazide MR is relatively low compared to other sulfonylureas, with studies showing hypoglycemia rates of approximately 0.7% 1
• Comparative studies have shown fewer hypoglycemic episodes with gliclazide MR compared to glimepiride (3.7% vs 8.9% of patients) 5
• No severe hypoglycemic episodes requiring third-party assistance were observed in clinical trials with gliclazide MR 4

Practical Dosing Recommendations

• For patients with type 2 diabetes inadequately controlled on diet and exercise: Start with one 60mg tablet daily 4
• For patients switching from another oral antidiabetic: Start with one 60mg tablet and adjust based on glycemic response 2
• During Ramadan: For patients on once-daily gliclazide MR, the dose should be given before the sunset meal (Iftar) 2
• For elderly patients: Start with the standard dose, as studies show similar efficacy and safety profiles to the general population 4

Common Pitfalls to Avoid

• Avoid exceeding the maximum daily dose of 120mg as this does not provide additional benefit but may increase the risk of adverse effects 1, 3
• Do not split or crush gliclazide MR tablets as this will affect the modified-release properties (unless they are specifically scored, breakable formulations) 1
• Be cautious when combining with insulin, as this combination may increase the risk of hypoglycemia 2
• Monitor patients closely during acute illness, as sulfonylureas may need to be temporarily suspended during intercurrent illness 2