Diamicron MR 60 mg 30 tablets

Diamicron MR 60 mg 30 tablets

Composition:

Active Ingredient: Each modified-release tablet contains Gliclazide — 60 mg.
Excipients:
Calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, microcrystalline cellulose.

Product Description:

• Diamicron MR is an oral hypoglycemic agent belonging to the second-generation sulfonylurea class.
• It stimulates insulin secretion by pancreatic beta cells, increases peripheral tissue sensitivity to insulin, and stimulates intracellular enzyme activity (specifically muscle glycogen synthase). 
• The medication reduces the time interval from meal intake to the onset of insulin secretion, restores the early peak of insulin secretion, and decreases the postprandial hyperglycemia peak.
• Gliclazide reduces platelet adhesion and aggregation, slows the development of parietal thrombi, increases vascular fibrinolytic activity, and normalizes vascular permeability. 
• It possesses anti-atherogenic properties: it reduces blood levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C), increases high-density lipoprotein cholesterol (HDL-C), reduces free radical activity, prevents microthrombosis, and improves microcirculation.
• In diabetic nephropathy, long-term administration of gliclazide achieves a significant reduction in proteinuria.

Indications for Use:

Type 2 Diabetes Mellitus:
In adults when diet, physical exercise, and weight reduction alone are insufficient to achieve glycemic control.
Prevention of Complications in Type 2 Diabetes:
Reduction of the risk of microvascular (nephropathy, retinopathy) and macrovascular complications (myocardial infarction, stroke).

Method of Administration and Dosage:

• Intended for oral administration.
• The tablet should be taken as a single daily dose at breakfast time, swallowed whole (without crushing or chewing) with a glass of water.
• Initial Dose: 30 mg (half of a 60 mg tablet) once daily.
  Dose Titration: If glycemic control is adequate, 30 mg may be maintained.
  If control is inadequate, the daily dose may be step-wise increased to 60 mg (1 tablet), 90 mg (1.5 tablets), or 120 mg (2 tablets) daily.
• Maximum Daily Dose: 120 mg (taken as a single dose during breakfast).
• Missed Dose: If a dose is missed, do not increase the next dose to compensate.

Contraindications:

• Type 1 diabetes mellitus.
• Diabetic ketoacidosis, diabetic pre-coma, and coma.
• Severe renal or hepatic impairment.
• Concomitant treatment with miconazole.
• Pregnancy and lactation.
• Children and adolescents under 18 years of age.
• Hypersensitivity to gliclazide, other sulfonylureas, sulfonamides, or any of the excipients.

Precautions:

• Hypoglycemia Risk: Should only be prescribed to patients who have a regular food intake (including breakfast).
  Regular carbohydrate intake is essential, as the risk of hypoglycemia increases if a meal is delayed, inadequate, or if physical exertion is unbalanced.
• Management of Hypoglycemia: For mild hypoglycemic symptoms in a conscious patient, oral glucose or carbohydrates should be administered. If consciousness is lost, intravenous glucose solution or intramuscular/subcutaneous glucagon is required.
  Following recovery of consciousness, carbohydrate-rich food must be provided to prevent relapse.
• Monitoring: Regular monitoring of fasting and postprandial blood glucose levels, as well as glycated hemoglobin (HbA1c), is required during treatment.
• Drug Interactions: Co-administration with verapamil requires regular blood glucose monitoring; with acarbose, careful monitoring and dose adjustment of hypoglycemic agents are needed.
  Concomitant use with cimetidine is not recommended.

Adverse Reactions / Side Effects:

• Endocrine System: Hypoglycemia (in cases of missed meals or overdose).
• Gastrointestinal System: Rarely — epigastric pain, nausea, vomiting, dyspepsia, diarrhea, constipation.
• Hematopoietic System: Rare cases of thrombocytopenia, leukopenia, anemia, agranulocytosis (usually reversible upon drug discontinuation).
• Skin and Subcutaneous Tissue: Skin rash, pruritus, urticaria, erythema.
• Hepato-biliary System: Transient elevation of liver enzymes, hepatitis (requires treatment discontinuation).

Pregnancy and Lactation:

• Contraindicated during pregnancy.
• If pregnancy is planned or occurs, treatment must be discontinued and switched to insulin therapy.
• It is unknown whether gliclazide is excreted in human breast milk.
• Due to the risk of neonatal hypoglycemia, use during breastfeeding is contraindicated.

Storage Conditions:

Store in a dry, dark place at a temperature not exceeding 30 °C.
Keep out of reach of children.

Packaging:

Cardboard box containing blisters of 10 tablets (total 30 tablets) with an official patient information leaflet.