See Supplemental Patient Information
- Sulphonylurea drugs may produce moderate or severe hypoglycaemia thus, proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Hypoglycaemia may occur if the patient's dietary intake is reduced particularly in the following conditions; in patients controlled by diet alone, accidental overdose, malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes, low calorie or glucose intake, elderly, debilitated patients, patients with hepatic or renal impairment
- If symptoms of hypoglycaemia such as sweating, pallor, hunger pangs, tachycardia or sensation of malaise occur, Oral glucose administration, dose adjustments and hospitalisation may be required in severe cases. Adjust the dose of gliclazide according to the blood glucose response and to the 24 hour urinary glucose during the first days of treatment
- Therapy may cause hemolytic anemia in patients with glucose 6-phosphate dehydrogenase (G6DP) deficiency, caution should be advised and an alternative non sulfonylurea treatment may be initiated
- Regular monitoring of glycated hemoglobin and blood glucose levels is recommended
- Therapy with gliclazide does not prevents the secondary complications peculiar to diabetes mellitus
- Temporary loss of glycemic control can occur in stabilized diabetic patients, when exposed to stress such as fever, trauma, infection, or surgery, withhold gliclazide therapy and temporarily administer insulin
- Concomitant administration of miconazole via systemic route may potentiate the hypoglycemic effect and may also lead to coma
Cautions: Use cautiously in
- Mild-moderate renal impairment
- Mild-moderate hepatic impairment
- Alcohol abuse
- Risk of hypoglycemia
- Elderly patients
- G6PD deficiency
- Concomitant therapy with other antidiabetic agents
- Concomitant therapy with beta blockers, angiotensin converting enzyme inhibitors, H2-receptor antagonists, MAOIs, sulfonamides, NSAIDs, thiazide diuretics, barbiturates
Supplemental Patient Information
- Inform the patient and his family members about the risks of hypoglycemia, its symptoms, treatment and conditions that predispose to its development
- Advise the patient of the importance of following diet, of taking regular exercise, and of regular monitoring of blood glucose levels
Pregnancy Category:NR; contraindicated
Breastfeeding: Safety and efficacy in lactation have not been established. It is unknown if the drug is excreted in human breast milk and due to the risk of neonatal hypoglycemia, breastfeeding is contraindicated during treatment with this drug
