Edvila-M® combines two antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes:
Vildagliptin: A dipeptidyl peptidase-4 (DPP-4) inhibitor that slows the inactivation of incretin hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), increase insulin synthesis and release from pancreatic beta cells and reduce glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production.
Metformin Hydrochloride: A biguanide that decreases hepatic glucose production, reduces intestinal absorption of glucose, and enhances peripheral glucose uptake and utilization.
Edvila-M® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Vildagliptin and Metformin is appropriate.
Adults: Based on the patient's current dose of Metformin, Edvila-M® may be initiated at either 50 mg/500 mg or 50 mg/850 mg twice daily (one tablet in the morning and the other in the evening).
The recommended daily dose is 100 mg Vildagliptin and 2000 mg Metformin HCl.
Patients receiving Vildagliptin and Metformin as separate tablets may be switched to Edvila-M® containing the same doses of each component.
Doses higher than 100 mg of Vildagliptin are not recommended.
To minimize gastrointestinal symptoms associated with Metformin, take Edvila-M® with or just after food.
Edvila-M® is contraindicated in patients with:
Hypersensitivity to the active substances or any excipients.
Renal impairment (creatinine clearance <60 mL/min).
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
Type 1 diabetes.
Lactic Acidosis: This rare but serious condition can occur due to Metformin accumulation. If metabolic acidosis is suspected, discontinue treatment immediately and hospitalize the patient.
Monitor serum creatinine at least once a year in patients with normal renal function and 2–4 times a year in patients with impaired renal function or in elderly patients.
Exercise caution in elderly patients and monitor renal function regularly, especially when initiating antihypertensives, diuretics, or NSAIDs.
Conduct liver function tests (LFTs) before initiating treatment, at three-month intervals during the first year, and periodically thereafter. Discontinue the medication if transaminase levels persist at three times the upper limit of normal or if liver dysfunction is detected.
Discontinue Edvila-M® 48 hours before elective surgery requiring general anesthesia and resume it no earlier than 48 hours afterward.
Most adverse reactions are mild and transient, not requiring treatment discontinuation.
Common side effects: Tremor, headache, dizziness, nausea, hypoglycemia, and fatigue.
Rare: Lactic acidosis (due to Metformin) and hepatic dysfunction.
Long-term clinical trials have shown no additional safety signals or unforeseen risks.
Pregnancy: No adequate data are available for Vildagliptin and Metformin use in pregnant women. Avoid use during pregnancy unless the potential benefit outweighs the risk.
Nursing Mothers: It is unknown if Vildagliptin is excreted in human milk. Avoid use during lactation due to a lack of data.
Pediatric Use: Not recommended for patients under 18 years of age.
Geriatric Use: Monitor renal function regularly. Not recommended for patients over 75 years due to insufficient studies in this population.
No significant interactions with pioglitazone, metformin, glibenclamide, digoxin, warfarin, amlodipine, ramipril, valsartan, or simvastatin.
Glucose-lowering effects may be reduced by thiazides, corticosteroids, thyroid products, and sympathomimetics.
Antihyperglycemic effect may be altered by glucocorticoids, beta-2 agonists, diuretics, and ACE inhibitors. Adjust dosages as needed and monitor blood glucose levels.
