Diaoptim Mr 60mg - 30 Tablet

                                    Product Description:

Diaoptim MR contains 60 mg modified-release gliclazide tablets intended for the treatment of non-insulin-dependent adults (type 2 diabetes) when diet, exercise, and weight loss alone are insufficient to control blood glucose.

Directions for Use:

The daily dose of Diaoptim MR 60 mg may vary from half a tablet to two tablets daily, i.e., from 30 to 120 mg, taken orally in a single dose at breakfast time. Each tablet is divisible.

It is recommended to swallow the tablet(s) whole without crushing or chewing.

If a dose is missed, do not increase the dose taken the following day.

As with any hypoglycemic agent, the dose should be adjusted according to the patient's metabolic response (blood glucose, HbA1c).

If blood glucose is effectively controlled, this dose can be used for maintenance treatment.

If blood glucose control is not adequately controlled, the dose may be increased to 60, 90, or 120 mg daily, in successive doses.

The interval between each dose increase should be at least one month, except for 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.

Warnings and Precautions:

Hypoglycemia: This treatment should only be prescribed if the patient is likely to eat a regular diet (including breakfast). It is important to consume carbohydrates regularly due to the increased risk of hypoglycemia if a meal is eaten late, if an insufficient amount of food is consumed, or if the diet is low in carbohydrates. Hypoglycemia is more likely to occur during low-calorie diets, after prolonged or strenuous exercise, alcohol consumption, or when using a combination of hypoglycemic agents.

Careful patient selection, dosage adjustments, and clear patient guidance are essential to reduce the risk of hypoglycemic episodes.

Factors that increase the risk of hypoglycemia: patient refusal or (especially in the elderly) inability to cooperate, malnutrition, irregular mealtimes, skipped meals, periods of fasting or altered diet, imbalance between exercise and carbohydrate intake, renal impairment, severe hepatic impairment, overdose, certain endocrine disorders.

Renal and hepatic impairment: The pharmacokinetics and/or pharmacodynamics of gliclazide may be altered in patients with hepatic impairment or severe renal failure. The hypoglycemic episode that occurs 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 therapy may be affected by any of the following: concomitant administration of St. John's wort (Hypericum perforatum), fever, trauma, infection, or surgical intervention.

The hypoglycemic efficacy of any oral antidiabetic agent, including gliclazide, declines over time in many patients. This may be due to progression of diabetes or decreased response to treatment. This phenomenon is known as secondary failure, which differs from primary failure, when the active substance is ineffective from the time of initial administration. Appropriate dose adjustment and dietary compliance should be considered before a patient is classified as a secondary failure.

Dysglycemia: Blood glucose disturbances, including hypoglycemia and hyperglycemia, have been reported in diabetic patients receiving concomitant treatment with fluoroquinolones, particularly in elderly patients. In fact, careful monitoring of blood glucose is recommended in all patients receiving Diaoptim MR 60 mg and a fluoroquinolone concomitantly.

Treatment of patients with G6PD deficiency with sulfonylurea agents can lead to hemolytic anemia. Because gliclazide belongs to the sulfonylurea class of drugs, caution should be exercised in patients with G6PD deficiency, and a non-sulfonylurea alternative should be considered.

This drug is contraindicated in the following cases:

Hypersensitivity to the active ingredient or any of the excipients, other sulfonylureas, or sulfonamides.

Type 1 diabetes.

Diabetic ketoacidosis, diabetic coma, or severe renal or hepatic impairment: In these cases, insulin is recommended.

Treatment with miconazole.

Breastfeeding.

Ingredients:

Each tablet contains 60 mg of gliclazide.

Product Details:

Brand Name: DiaOptim