Diaoptim MR contains gliclazide 60 mg modified-release tablets indicated for the treatment of noninsulin-dependent (type II) adults when dietary measures, physical exercise, and weight loss alone are not sufficient to control blood glucose.
How to use:
The daily dose of Diaoptim MR 60 mg may vary from one-half to 2 tablets per day, i.e. from 30 to 120 mg taken orally in a single intake at breakfast time, each tablet is dividable.
It is recommended to swallow the tablet(s) without crushing or chewing.
If a dose is forgotten, there must be no increase in the dose taken the next day.
As with any hypoglycemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbA1c).
If blood glucose is effectively controlled, this dose may be used for maintenance treatment.
If blood glucose is not adequately controlled, the dose may be increased to 60, 90, or 120 mg daily, in successive steps.
The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not decreased after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment.
The maximum recommended daily dose is 120 mg.
Caution & Warnings:
This treatment should be prescribed only if the patient is likely to have a regular food intake (including breakfast).
It is important to have a regular carbohydrate intake due to the increased risk of hypoglycemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrates.
Hypoglycemia is more likely to occur during low-calorie diets, following prolonged or strenuous exercise, alcohol intake or if a combination of hypoglycemic agents is being used.
Careful selection of patients, of the dose used, and clear patient directions are necessary to reduce the risk of hypoglycemic episodes.
Factors which increase the risk of hypoglycemia: patient refuses or (particularly in elderly subjects) is unable to co-operate, malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes, imbalance between physical exercise and carbohydrate intake, renal insufficiency, severe hepatic insufficiency, overdose, certain endocrine disorders
Renal and hepatic insufficiency: the pharmacokinetics and/or pharmacodynamics of gliclazide may be altered in patients with hepatic insufficiency or severe renal failure.
A hypoglycemic episode occurring in these patients may be prolonged, so appropriate management should be initiated.
Poor blood glucose control :
Blood glucose control in a patient receiving oral antidiabetic treatment may be affected by any of the following:
concomitant administration of St. John’s Wort (Hypericum perforatum) preparation, fever, trauma, infection or surgical intervention.
The hypoglycemic efficacy of any oral antidiabetic agent, including gliclazide, is attenuated over time in many patients: this may be due to progression in the severity of the diabetes, or to a reduced response to treatment. This phenomenon is known as secondary failure which is distinct from primary failure, when an active substance is ineffective since the first intake. Adequate dose adjustment and dietary compliance should be considered before classifying the patient as secondary failure.
Dysglycaemia : Disturbances in blood glucose, including hypoglycemia and hyperglycemia have been reported in diabetic patients receiving concomitant treatment with fluoroquinolones, especially in elderly patients. Indeed, careful monitoring of blood glucose is recommended in all patients receiving at the same time Diaoptim MR 60 mg and a fluoroquinolone.
Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to hemolytic anemia. Since gliclazide belongs to the chemical class of sulfonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.
This medicinal product is contraindicated in:
hypersensitivity to the active substance or to any of the excipients , other sulfonylureas, sulfonamides,
type 1 diabetes,
diabetic pre-coma and coma, diabetic keto-acidosis,
severe renal or hepatic insufficiency: in these cases the use of insulin is recommended,
treatment with miconazole.
One modified-release tablet contains gliclazide 60 mg.
Lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silica.