Megline^®

Megline is the preparation of Imeglimin which is the first representative of a new class of oral anti-diabetics, glimins. It is designed to target key components of type 2 diabetes pathophysiology. Its mechanism of action involves dual effects to improve pancreatic β-cell function and to enhance insulin action in key tissues, including liver and skeletal muscle. At the cellular molecular level, the molecule modulates mitochondrial function, as documented in several cell types, leading to improvements in cellular energy metabolism and protection from cell death associated with excess reactive oxygen species (ROS) formation or other insults. An additional effect via increased NAD synthesis and enhanced Ca++ mobilization is operative in islet β-cells.

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Megline is indicated for the treatment of type 2 diabetes mellitus.

Route of administration: Megline should be taken orally.

The usual adult dosage is 2 tablets (1000 mg) at a time, twice daily in the morning and evening.

Pregnancy: The safety of imeglimin in pregnant women has not been established. It should be used in pregnant women who may possibly be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment.

Lactation: Breast-feeding must be discontinued during administration of imeglimin in lactating women.

Use in children and adolescents
Safety and effectiveness of imeglimin have not been established in pediatric patients.

It may cause hypoglycemic symptoms (hungry, cold sweat, pale face, easy tiredness, tremor of limbs, convulsions, decreased consciousness, etc.). Therefore, pay close attention while working at heights, drive a car, or operate dangerous machinery. If hypoglycemic symptoms occur, take sugar-containing foods or sugar. If taking alfa-glucosidase inhibitor (acarbose, voglibose, miglitol) in combination with this medicine, take glucose.

The most common side effects are nausea, vomiting, diarrhea, constipation, weakness, hungry feeling, sweating (hypoglycemia).

It is contraindicated in patients with history of known hypersensitivity to imeglimin or any other components of this product. It is also contraindicated in patients with severe ketosis, diabetic coma or pre-coma and also for immediate remedy in type 1 diabetes of hyperglycemias with infusion and insulin.

Drug interaction with medication: No drug-drug interaction has been reported yet

Drug interaction with food and others: Not applicable.

Preclinical studies have demonstrated a glucose-independent insulinotropic effect of imeglimin at supratherapeutic doses, which raises concerns about overdosing and the associated risk of hypoglycemia if dosing is inappropriate, in patients with renal (or hepatic) impairment and in patients with increased sensitivity to imeglimin. In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.

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Megline 500 mg Tablet: Each film coated tablet contains Imeglimin Hydrochloride INN 500 mg.

Storage
Keep away from the reach of children. Store below 30°C in a dry place, protected from light.

Packing
Megline 500 mg Tablet: Carton of 20 tablets in blister pack.