Dieta M 1 mg+500 mg (Tablet (Extended Release))

Indications

• Adjunct to diet and exercise in type 2 diabetes mellitus patients
• Inadequate glycemic control with monotherapy of glimepiride or metformin
• 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
• Used in the management of type 2 diabetes

Dosage

• Governed by desired blood glucose level
• Must be the lowest sufficient to achieve desired metabolic control
• Regular monitoring of glucose levels in blood and urine
• Maximum recommended dose: 8mg glimepiride and 2000mg metformin

Administration

• Tablet must be swallowed whole, not crushed or chewed

Interaction

• Metabolized by cytochrome P450 2C9 (CYP2C9)
• Potential interactions with inducers or inhibitors of CYP 2C9
• 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
• Concomitant use not recommended with alcohol and iodinated contrast agents
• Inhibitors or inducers of organic cation transporters can alter metformin's efficacy and renal absorption

Contraindications

• Hypersensitivity to glimepiride, metformin, or other sulfonylureas
• Pregnancy and lactation
• Severe impairment of liver function
• Severe renal failure or dysfunction
• Acute metabolic acidosis
• Acute or chronic diseases causing tissue hypoxia
• Acute alcohol intoxication

Side Effects

• Hypoglycemia
• Temporary visual impairment
• Gastrointestinal symptoms
• Changes in blood picture
• Hepatitis, liver enzyme elevation, cholestasis
• Alopecia
• Allergic or pseudo allergic reactions
• Decrease in serum sodium concentration
• Weight gain with sulfonylureas
• Gastrointestinal symptoms
• Metallic taste
• Decrease of vitamin B12 absorption
• Lactic acidosis
• Hemolytic anemia
• Reduction of thyrotropin level
• Hypomagnesemia
• Encephalopathy
• Photosensitivity
• Liver function tests abnormalities and hepatitis

Pregnancy & Lactation

• Glimepiride must not be taken during pregnancy
• Metformin is not recommended during pregnancy
• Glimepiride must not be taken by breastfeeding women
• Decision to discontinue nursing or metformin use should be made based on importance of the compound to the mother

Precautions & Warnings

• Increased risk of hypoglycemia in initial weeks of treatment, necessitating careful monitoring
• Hypoglycemia risk factors may necessitate dose adjustment
• Caution in patients with G6PD-deficiency
• Regular monitoring of thyroid-stimulating hormone (TSH) levels in hypothyroidism patients
• Decrease in vitamin B12 levels with long-term metformin treatment
• Monitoring of vitamin B12 level is recommended

Use in Special Populations

• Insufficient data to recommend pediatric use
• Renal function assessment before and during treatment
• Maximum daily doses based on GFR levels

Overdose Effects

• Life-threatening hypoglycemia with glimepiride overdose
• Hypoglycemia unlikely with metformin overdose
• High overdose or concomitant risks may lead to lactic acidosis
• Pancreatitis may occur in metformin overdose

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

• Store in a cool and dry place, protected from light

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