Glimitus M 2 mg+500 mg (Tablet (Extended Release))

Indications

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

Pharmacology

• Sulfonylurea antidiabetic agent
• Decreases blood glucose concentration
• Stimulates release of insulin from pancreatic beta cells
• Reduces basal hepatic glucose production
• Increases peripheral tissue sensitivity to insulin and glucose uptake

Dosage

• Governed by desired blood glucose level
• Lowest dosage sufficient for desired metabolic control
• Regular measurement of glucose levels in blood and urine
• Avoid mistaking by subsequently taking a larger dose
• Dose reduction or cessation for avoidance of hypoglycemia

Administration

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

Interaction

• Metabolized by cytochrome P450 2C9 (CYP2C9)
• Potentiation of blood-glucose-lowering effect by drugs like insulin, ACE inhibitors, anabolic steroids
• Weakening of blood-glucose-lowering effect by drugs like barbiturates, corticosteroids, diazoxide
• Alcohol intake may potentiate or weaken the blood-glucose-lowering action
• Bile acid sequestrant (e.g. Colesevelam) binds to glimepiride and reduces its absorption

Contraindications

• Hypersensitivity to glimepiride, metformin, sulfonylureas, sulfonamides, or any excipients
• Pregnancy
• Breastfeeding
• Severe impairment of liver function
• Severe renal failure or dysfunction
• Acute metabolic acidosis
• Hepatic insufficiency
• Acute alcohol intoxication, alcoholism

Side Effects

• Hypoglycemia
• Visual impairment at the start of treatment
• Gastrointestinal symptoms like nausea, vomiting, abdominal pain, diarrhea
• Changes in blood picture like thrombocytopenia, leucopenia
• Alopecia, allergic reactions, decrease in serum sodium concentration
• Weight gain, metallic taste, vitamin B12 absorption reduction, lactic acidosis, hemolytic anemia

Pregnancy & Lactation

• Glimepiride not recommended during pregnancy
• Metformin not recommended during pregnancy
• Glimepiride not recommended for breastfeeding women
• Metformin excreted into milk, decision to discontinue nursing or metformin to be made

Precautions & Warnings

• Increased risk of hypoglycemia in initial weeks of treatment
• Caution in patients with G6PD-deficiency for sulfonylurea agents
• Regular monitoring of thyroid-stimulating hormone (TSH) levels in patients with hypothyroidism
• Long-term treatment associated with decrease in vitamin B12 serum levels

Use in Special Populations

• Insufficient data for pediatric use
• Renal impairment assessment before initiation of treatment
• Maximum daily dose of metformin based on GFR
• Consideration of individual monocomponents if adequate strength of this tablet is not available

Overdose Effects

• Acute severe life-threatening hypoglycemia
• Immediate treatment and physician notification for glimepiride overdose
• Lactic acidosis with high overdose or concomitant risks for metformin
• 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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