Usage And Safety
Dosage
Based on the patient’s current dose of metformin HCl, Vildagliptin + Metformin HCl may be initiated at either the 50mg + 500mg, 50mg + 850mg or 50mg + 1000mg tablet twice daily, one tablet in the morning and one tablet in the evening. Vildagliptin + Metformin HCl should be given with meals to reduce the gastrointestinal side effects associated with metformin HCl. When using Vildagliptin + Metformin HCl the maximum daily dose of vildagliptin (100mg) should not be exceeded. Children : Not Recommended.
Side Effects
Hypoglycemia, tremor, headache, dizziness & nausea , Fatigue , Hypoglycemia, dizziness, tremor, hyperhidrosis & asthenia , Decreased blood glucose, headache, chills, nausea, gastro-esophageal reflux disease , diarrhea & flatulence.
Drug Interactions
Thiazides, corticosteroids, thyroid products and sympathomimetics , Furosemide , Nifedipine , Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) , estrogens, oral contraceptives, phenytoin, nicotinic acid , alcohol.
Indication
Vildagliptin + Metformin HCl is indicated for the treatment of patients with Type 2 diabetes mellitus (T2DM). Vildagliptin + Metformin HCl is indicated as an adjunct to diet and exercise to improve glycemic control in patients whose diabetes is not adequately controlled on metformin HCl alone or who are already treated with the combination of vildagliptin and metformin HCl, as separate tablets.
When not to Use
Vildagliptin + Metformin HCl combination is contraindicated in: – Patients with known hypersensitivity to vildagliptin or metformin HCl or to any excipient of the product. – Diabetic ketoacidosis or diabetic pre-coma.
Warnings
Warning 1
In diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
Warning 2
Use of vildagliptin has been associated with a risk of developing acute pancreatitis. If pancreatitis is suspected, vildagliptin should be discontinued and if acute pancreatitis is confirmed, vildagliptin should not be restarted. Caution should be exercised in patients with a history of acute pancreatitis.
Warning 3
Treatment with metformin should be discontinued 48 hours before elective surgery with general anesthesia and should not usually be resumed earlier than 48 hours afterwards.
