Amaryl M 1 mg+500 mg (Tablet (Prolonged Release))

Therapeutic Class

• Combination Oral hypoglycemic preparations

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 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
• Improves 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
• Maximum daily dose of 8mg glimepiride and 2000mg metformin

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 with insulin and other oral antidiabetics
• Weakening of blood-glucose-lowering effect with corticosteroids and diuretics
• Bile acid sequestrant reduces glimepiride absorption
• Concomitant use of metformin with alcohol, iodinated contrast agents, glucocorticoids, and beta-2-agonists not recommended

Contraindications

• Hypersensitivity to glimepiride, metformin, or any excipients
• Pregnancy
• Breastfeeding
• Severe impairment of liver function
• Severe renal failure or dysfunction

Side Effects - Glimepiride

• Hypoglycaemia
• Severe hypoglycaemic attack resembling stroke
• Temporary visual impairment at start of treatment
• Gastrointestinal symptoms
• Hepatitis, elevated liver enzyme levels, cholestasis, jaundice
• Allergic or pseudo-allergic reactions
• Weight gain
• Changes in blood picture: thrombocytopenia, leucopenia, hemolytic anemia
• Skin reactions: alopecia, allergic reactions

Side Effects - Metformin

• Gastrointestinal symptoms
• Metallic taste
• Decreased vitamin B12 absorption
• Lactic acidosis
• Hemolytic anemia
• Reduction of thyrotropin level
• Hypomagnesemia
• Encephalopathy
• Photosensitivity
• Hepatobiliary disorders

Pregnancy & Lactation

• Glimepiride must not be taken during pregnancy
• Metformin should not be used in pregnancy
• Glimepiride must not be taken by breastfeeding women
• Metformin use during lactation should be decided based on importance to the mother

Precautions & Warnings - Glimepiride

• Increased risk of hypoglycemia in initial weeks of treatment
• Careful monitoring required for patients with G6PD-deficiency
• Hemolytic anaemia reported in G6PD-deficient patients

Precautions & Warnings - Metformin

• Regular monitoring of thyroid-stimulating hormone (TSH) levels recommended 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: Assess GFR before initiation, then annually

Overdose Effects - Glimepiride

• May lead to severe life-threatening hypoglycaemia
• Immediate treatment and admission to hospital required for severe reactions

Overdose Effects - Metformin

• High overdose may lead to lactic acidosis
• Treatment in hospital required for lactic acidosis

Storage Conditions

• Store in a cool and dry place
• Protected from light

Related Brands

• Losucon M 1 mg+500 mg (Tablet (Sustained Release)) - incepta-pharmaceuticals-ltd
• Gemer 1 mg+500 mg (Tablet (Extended Release)) - sun-pharmaceutical-bangladesh-ltd