Viglimet 50/850mg (30pcs Box)

Indications

This tablet is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus whose diabetes is not adequately controlled on Metformin Hydrochloride or Vildagliptin alone, or who are already receiving the combination of Vildagliptin and Metformin Hydrochloride as separate tablets.

Pharmacology

Vildagliptin works largely by blocking DPP-4 (Dipeptidyl peptidase-4), the enzyme that degrades the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). Vildagliptin inhibits DPP-4 action quickly and completely, resulting in elevated fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP. Vildagliptin enhances insulin production from pancreatic beta cells while decreasing glucagon secretion from alpha cells by raising endogenous levels of these incretin hormones. Increased incretin hormone levels cause a rise in the insulin/glucagon ratio during hyperglycemia, which leads in a reduction in fasting and postprandial hepatic glucose production, resulting in lower glycemia.

Metformin Hydrochloride is an oral antihyperglycemic medication of the biguanide class that is used to treat type 2 diabetes. It reduces both basal and postprandial plasma glucose levels. It has a different mode of action than sulfonylureas and does not cause hypoglycemia. Glucomin reduces hepatic glucose synthesis, reduces intestinal glucose absorption, and increases 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 day) was combined with Metformin Hydrochloride, no clinically significant pharmacokinetic interaction was detected (1,000 mg once daily). Vildagliptin has a minimal chance of causing medication interactions. Because vildagliptin is neither a cytochrome P (CYP) 450 enzyme substrate, nor does it inhibit or induce CYP 450 enzymes, it is unlikely to interact with co-medications that are CYP 450 enzyme substrates, inhibitors, or inducers. Following co-administration of vildagliptin with other oral antidiabetics (glibenclamide, pioglitazone, metformin hydrochloride), amlodipine, digoxin, ramipril, simvastatin, valsartan, or warfarin, no clinically significant interactions were identified. Furosemide, nifedipine, and glyburide, on the other hand, raise Metformin Cmax and blood AUC while having no effect on Metformin renal clearance.

Contraindications

This combination is not recommended for individuals who have a history of hypersensitivity to Vildagliptin, Metformin Hydrochloride, or any of the excipients. It is not recommended for individuals with kidney illness or malfunction, acute myocardial infarction, or septicaemia. It is also not recommended for those who have congestive heart failure or who have acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. It should be temporarily stopped in patients having radiologic tests that include intravascular injection of iodinated contrast materials, because such products might induce abrupt changes in renal function.

Side Effects

Headache, tremor, dizziness, nausea, hypoglycemia, and other frequent side effects include:

Pregnancy & Lactation

It is also not recommended for those who have congestive heart failure or who have acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. There have been no research using the components of this combination. Because it is unknown if Vildagliptin and/or Metformin Hydrochloride are excreted in human milk, this combination should not be given to nursing mothers.

Precautions & Warnings

Metformin buildup might result in lactic acidosis. If metabolic acidosis is detected, therapy should be stopped and the patient should be admitted to the hospital very away. Serum creatinine levels should be checked at least once a year in individuals with normal renal function and twice a year in patients with serum creatinine levels beyond the upper limit of normal and in elderly patients. Special care should be used with older individuals whose renal function may deteriorate (e.g. when initiating antihypertensives, diuretics or NSAIDs). It is suggested that Liver Function Tests (LFTs) be monitored before to starting this medication, at three-monthly intervals for the first year, and then on a regular basis following that. If transaminase levels are elevated, patients should have a second liver function test to confirm the result and then be monitored with regular liver function tests until the anomaly returns to normal. If AST or ALT levels remain at 3 times the upper limit of normal, Vildagliptin and Metformin pills should be discontinued in patients who develop jaundice or other indications of liver impairment. Treatment with Vildagliptin and Metformin should not be restarted after LFT normalization and removal of Vildagliptin and Metformin. Vildagliptin and Metformin pills should be stopped 48 hours before elective surgery under general anesthetic and should not be restarted sooner than 48 hours later.

Storage Conditions

Keep away from light and heat in a dry area. Keep out of children's reach.