Diaoptim-Mr 60 Mg 30 Tablets

Product Description: 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: Hypoglycemia: 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. Ingredients One modified-release tablet contains gliclazide 60 mg. Lactose monohydrate- maltodextrin- hypromellose- magnesium stearate- anhydrous colloidal silica