Vildamet 50/500

Generic

Vildagliptin + Metformin Hydrochloride

Indications

Patients with type 2 diabetes mellitus who are not adequately controlled on Metformin Hydrochloride or Vildagliptin alone, or who are already treated with the combination of Vildagliptin and Metformin Hydrochloride as separate tablets, should take this tablet as an adjunct to diet and exercise to improve glycaemic control.

Pharmacology

Vildagliptin mainly acts by inhibiting DPP4 (dipeptidyl peptidase 4), which is responsible for breaking down the incretin hormones GLP1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin-promoting polypeptide). The administration of vildagliptin leads to rapid and complete inhibition of DPP4 activity, leading to an increase in the endogenous levels of incretin hormones GLP1 and GIP on an empty stomach and after meals. By increasing the endogenous levels of these incretin hormones, vildagliptin increases insulin secretion in pancreatic β cells and reduces glucagon secretion in α cells. The increase in the insulin/glucagon ratio during hyperglycemia due to the increased level of the hormone incretin leads to a decrease in fasting and postprandial liver glucose production, which leads to a decrease in blood sugar​​​​

Metformin Hydrochloride is an oral biguanide hypoglycemic agent for the treatment of type 2 diabetes. It lowers basal and postprandial blood sugar. Its mechanism of action is different from that of sulfonylureas and does not produce hypoglycemia. Glucosamine reduces liver glucose production, reduces intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Dosage & Administration

Adults: Based on the patient's current dose of Metformin, this combination may be initiated at twice daily, 1 tablet in the morning and the other in the evening. Patients receiving Vildagliptin and Metformin from separate tablets may be switched to this combination containing the same doses of each component. Doses higher than 100 mg of vildagliptin are not recommended. There is no clinical experience of Vildagliptin and Metformin in triple combination with other antidiabetic agents. Taking this combination with or just after food may reduce gastrointestinal symptoms associated with Metformin.

Interaction

When vildagliptin (100 mg once daily) was co-administered with metformin hydrochloride (1,000 mg once daily), no clinically relevant pharmacokinetic interactions were observed. The possibility of drug interaction with vildagliptin is very small. Since vildagliptin is not an enzyme substrate for cytochrome P (CYP) 450, nor does it inhibit or induce CYP 450 enzymes, it is unlikely that it will interact with drugs that are substrates, inhibitors, or inducers of these enzymes. Due to these studies, after co-administration with vildagliptin, no other oral hypoglycemic drugs (glibenclamide, pioglitazone, metformin hydrochloride), amlodipine, digoxin, ramipril, sinus Clinically relevant interactions of vastatin, valsartan or warfarin. On the other hand, furosemide, nifedipine and glibenclamide increased the Cmax of metformin and the AUC in blood, while the renal clearance of metformin did not change.

Contraindications

Patients who have a known hypersensitivity to Vildagliptin, Metformin Hydrochloride, or any of the excipients should avoid this combination. It's not recommended for people who have kidney illness or malfunction, a heart attack, or septicaemia. It's also not recommended for people who have congestive heart failure or who have acute or chronic metabolic acidosis, such as diabetic ketoacidosis, with or without coma. It should be temporarily stopped in patients undergoing radiologic examinations that require intravascular administration of iodinated contrast materials, as such products can cause acute renal dysfunction.

Side Effects

The most common side effects are headache, tremor, dizziness, nausea, hypoglycaemia etc.

Pregnancy & Lactation

Because there are no good and well-controlled studies in pregnant women, this combination should not be taken during pregnancy unless the possible benefit outweighs the risk to the fetus. There have been no research done on the components of this combination. This combination should not be given to breast-feeding women because it is unknown whether Vildagliptin and/or Metformin Hydrochloride are excreted in human milk.

Precautions & Warnings

Due to the accumulation of metformin, lactic acidosis can occur. If metabolic acidosis is suspected, treatment should be stopped and hospitalized immediately. Patients with normal renal function should be monitored for serum creatinine at least once a year, and patients with serum creatinine levels above the upper limit of normal and elderly patients should be monitored 2-4 times a year. For elderly patients who may affect kidney function (for example, when starting antihypertensives, diuretics, or non-steroidal anti-inflammatory drugs), special care should be taken. It is recommended to check the liver function test (LFT) before starting to use the drug, check it every three months in the first year, and check it regularly thereafter. If the transaminase level is elevated, the patient should be monitored by a second liver function evaluation to confirm this finding, and then frequent liver function tests should be performed until the abnormality returns to normal. If AST or ALT persists at 3 x ULN, vildagliptin and metformin tablets should be discontinued. Patients with jaundice or other signs of liver dysfunction. After cessation of vildagliptin and metformin and the LFT returns to normal, treatment with vildagliptin and metformin should not be restarted. Vildagliptin and metformin tablets should be discontinued 48 hours prior to elective surgery under general anesthesia and generally should not be resumed earlier than 48 hours after surgery.

Therapeutic Class

Combination Oral hypoglycemic preparations

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.

Pharmaceutical Name

Opsonin Pharma Ltd.