Gemer 2 mg+500 mg (Tablet (Extended Release))

Indications

• Adjunct to diet and exercise in type 2 diabetes mellitus patients
• Aid in achieving adequate glycemic control
• Replacement of combination therapy of glimepiride and metformin

Pharmacology

• Decreases blood glucose concentration
• Stimulates insulin release from pancreatic beta cells
• Improves sensitivity of beta cells to glucose stimulus
• Reduces basal hepatic glucose production
• Increases peripheral tissue sensitivity to insulin
• Improves glucose uptake
• Non-fasting hypoglycaemic action persists for 24 hours

Dosage

• Governed by desired blood glucose level
• Must be lowest sufficient for desired metabolic control
• Regular measurement of glucose levels in blood and urine
• Avoid corrective dosing with larger doses
• Possible dose reduction or cessation as treatment proceeds
• Highest recommended daily dose of 8 mg glimepiride and 2000 mg metformin

Administration

• Must be swallowed whole
• Not to be crushed or chewed

Interaction

• Metabolized by cytochrome P450 2C9
• Potential interaction with inducers or inhibitors of CYP 2C9
• Possible potentiation or weakening of blood-glucose-lowering effect with various drugs
• Alcohol intake may affect blood-glucose-lowering action
• Bile acid sequestrant reduces glimepiride absorption

Contraindications

• Hypersensitivity to glimepiride, metformin, other sulfonylureas, or excipients
• Pregnancy
• Breastfeeding
• Severe impairment of liver or renal function

Side Effects

• Hypoglycaemia
• Temporary visual impairment
• Gastrointestinal symptoms
• Hepatitis, liver enzyme elevation, cholestasis, jaundice
• Blood disorders (e.g., thrombocytopenia, leucopenia)
• Skin disorders (e.g., alopecia, allergic reactions)
• Weight gain
• Gastrointestinal symptoms (e.g., nausea, vomiting)
• Metallic taste
• Vitamin B12 absorption decrease
• Lactic acidosis
• Hemolytic anemia
• Reduction of thyrotropin level
• Hypomagnesemia
• Encephalopathy
• Photosensitivity
• Liver function test abnormalities

Pregnancy & Lactation

• Must not be taken during pregnancy
• Change over to insulin during pregnancy
• Diabetes should not be treated with metformin during pregnancy
• Use insulin to maintain blood glucose levels during pregnancy
• Must not be taken by breastfeeding women
• Excretion into milk in lactating rats
• Risk vs. benefit assessment for nursing mothers

Precautions & Warnings

• Initial weeks of treatment may increase risk of hypoglycaemia
• Careful monitoring in patients with G6PD-deficiency
• Regular monitoring of thyroid-stimulating hormone levels
• Long-term treatment associated with decrease in vitamin B12 levels
• Caution in patients with hypothyroidism

Use in Special Populations

• Insufficient data for pediatric use
• Assessment of GFR before initiation of treatment
• More frequent assessment of renal function in elderly
• Maximum daily dose in relation to declining renal function

Overdose Effects

• May lead to severe life-threatening hypoglycaemia
• Immediate treatment and hospitalization for severe reactions

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

• Store in cool and dry place below 25°C
• Protected from light

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