What information should be included on a pharmacy label for gliclazide (sulfonylurea)?

Pharmacy Labels for Gliclazide (Sulfonylurea)

Pharmacy labels for gliclazide should include warnings about hypoglycemia risk, instructions to take with meals, and specific dosing information based on the formulation (immediate-release or modified-release). 1

Essential Label Information

• Medication Name and Strength: Clearly state "Gliclazide" and the strength (e.g., 30 mg modified-release or 80 mg immediate-release) 1, 2

• Dosage Instructions:

  • For modified-release: "Take once daily in the morning with breakfast" 3, 2
  • For immediate-release: "Take with meals" (divided doses if >80 mg daily) 2

• Maximum Daily Dose Warning:

  • Modified-release: "Do not exceed 120 mg daily" 2
  • Immediate-release: "Do not exceed 320 mg daily" 1, 2

• Hypoglycemia Warning: "May cause low blood sugar. Carry quick-acting sugar source at all times" 1, 4

Additional Important Warnings

• Kidney Function: "Use with caution if you have kidney problems; initiate at lower doses if kidney function is reduced" 1

• Alcohol Warning: "Avoid alcohol consumption while taking this medication as it may cause unpredictable blood sugar levels" 4, 5

• Driving/Operating Machinery: "May cause dizziness or drowsiness. Use caution when driving or operating machinery until effects are known" 4

• Pregnancy/Breastfeeding: "Not recommended during pregnancy or breastfeeding; consult your doctor if you become pregnant" 1

Monitoring Instructions

• Blood Glucose Monitoring: "Monitor blood glucose regularly as directed by your healthcare provider" 1, 4

• Hypoglycemia Symptoms: "Watch for signs of low blood sugar: sweating, shakiness, confusion, fast heartbeat, hunger" 1, 5

• Storage Information: "Store at room temperature away from moisture and heat" 2

Special Considerations

• Elderly Patients: "Elderly patients should start with lower doses and monitor blood sugar more frequently due to increased risk of hypoglycemia" 4, 2

• Missed Dose Instructions: "If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take double doses" 4

• Drug Interactions: "Inform your doctor of all medications you are taking, especially other diabetes medications, as dose adjustments may be needed" 1, 5

• Refill Information: Include the number of refills authorized and expiration date 1

By including these elements on pharmacy labels for gliclazide, pharmacists can help ensure safe and effective use of this sulfonylurea medication while minimizing the risk of adverse effects, particularly hypoglycemia 1, 4.