Glims M XR 2 mg+500 mg (Tablet (Extended Release))

Indications

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

Pharmacology

• Decreases blood glucose concentration
• Stimulates the release of insulin from pancreatic beta cells
• Improves sensitivity of beta cells to glucose stimulus
• Reduces basal hepatic glucose production
• Increases peripheral tissue sensitivity to insulin

Dosage

• Dependent on desired blood glucose level
• Lowest dosage for desired metabolic control
• Regular measurement of glucose levels in blood and urine
• Maximum recommended daily doses
• Starting dose not to exceed daily doses of glimepiride or metformin

Administration

• Tablet must be swallowed whole
• Must not be crushed or chewed

Interaction

• Metabolized by cytochrome P450 2C9 (CYP2C9)
• Potentiation and hypoglycemia with concurrent use of certain drugs
• Weakening and raised blood glucose levels with concurrent use of certain drugs
• Influence of sympatholytic drugs on adrenergic counter-regulation to hypoglycemia
• Unpredictable influence of alcohol intake on blood-glucose-lowering action
• Bile acid sequestrant binding to glimepiride and reducing its absorption

Contraindications

• Hypersensitivity to glimepiride, metformin, or other sulfonylureas
• Pregnancy
• Breastfeeding
• Severe impairment of liver function
• Dialysis patients
• Hypersensitivity to metformin or any of the excipients
• Acute metabolic acidosis
• Severe renal failure
• Acute conditions altering renal function
• Conditions causing tissue hypoxia
• Hepatic insufficiency
• Acute alcohol intoxication
• G6PD-deficiency

Side Effects

• Hypoglycemia
• Visual impairment
• Gastrointestinal symptoms
• Liver enzyme elevation
• Thrombocytopenia
• Hepatitis
• Cholestasis
• Alopecia
• Allergic or pseudo allergic reactions
• Decrease in serum sodium concentration
• Weight gain
• Nausea
• Vomiting
• Diarrhea
• Loss of appetite
• Metallic taste
• Decrease of vitamin B12 absorption
• Lactic acidosis
• Hemolytic anemia
• Reduction of thyrotropin level
• Hypomagnesemia
• Encephalopathy
• Photosensitivity
• Liver function tests abnormalities

Pregnancy & Lactation

• Glimepiride must not be taken during pregnancy
• Metformin should not be used during pregnancy
• Glimepiride must not be taken by breastfeeding women

Precautions & Warnings

• Increased risk of hypoglycemia in initial weeks of treatment
• Risk factors for hypoglycemia
• Careful monitoring of hypoglycemia
• Treatment in G6PD-deficiency patients
• Regular monitoring of thyroid-stimulating hormone (TSH) levels
• Decrease in vitamin B12 serum levels

Use in Special Populations

• Insufficient data for pediatric use
• Assessment of GFR before initiation of treatment with metformin
• Dividing maximum daily dose into 2-3 daily doses
• Dose reduction in relation to declining renal function

Overdose Effects

• Severe life-threatening hypoglycemia with acute overdosage
• Medical emergency and hospital treatment for lactic acidosis
• Pancreatitis in the context of a metformin overdose

Therapeutic Class

Combination oral hypoglycemic preparations

Storage Conditions

Cool and dry place, protected from light

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