Glimepiride Stella 2mg (3 blisters x 10 tablets/box)

Indications

Noninsulin-dependent (type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone.

Contraindications

• Hypersensitivity to glimepiride, other sulfonylurea or sulfonamides or excipients in the tablet.
• Insulin dependent diabetes, diabetic coma, ketoacidosis.
• Severe renal or hepatic function disorders: A changeover to insulin is required.
• Pregnancy and lactation.

Compositon/Ingredients

Dosage and administration

Adults: Initial dosage in previously untreated patients: 1 – 2 mg daily. In debilitated, malnourished, or geriatric patients and in patients with hepatic or renal impairment and other patients at increased risk of hypoglycemia: 1 mg daily; in patients transferred from other antidiabetic agents: 1 – 2 mg daily, maximum of 2 mg daily.

Maintenance dosage: 1 – 4 mg daily (in patients receiving 1 mg of glimepiride daily, increase to 2 mg daily if adequate glycemic control has not been achieved after 1 – 2 weeks; after reaching the 2 mg dosage, adjustment according to the patient’s tolerance and therapeutic response); increasing in increments of no more than 2 mg daily at 1- to 2-week intervals, maximum of 8 mg daily.

Precaution

• Loss of control of blood glucose can occur at a patient whom stabilized on any diabetic regimen exposed to stress such as fever, trauma, infection, or surgery.
• Hypersensitivity reactions: There have been reports of hypersensitivity reactions including serious reactions such as anaphylaxis, angioedema, and Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, promptly discontinue glimepiride.
• Hemolytic anemia: There are reports of hemolytic anemia in both patients who did or did not have known glucose 6-phosphate dehydrogenase (G6PD) deficiency.
• Increased risk of cardiovascular mortality with sulfonylureas: The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin.
• The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or visual impairment. Patients should be advised to take precautions to drive or operate machinery.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take Glimepiride STELLA 2 mg.

Storage

Store at temperature below 30°C, protect from light.