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 works by blocking DPP-4 (Dipeptidyl peptidase-4), an enzyme that breaks down the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucagon-like peptide-2) (glucose-dependent insulinotropic polypeptide). Vildagliptin inhibits DPP-4 action quickly and completely, resulting in higher endogenous levels of the incretin hormones GLP-1 and GIP during fasting and postprandial periods. Vildagliptin enhances insulin secretion from the pancreatic beta cell while decreasing glucagon secretion from the alpha cell by raising endogenous levels of these incretin hormones. Increased incretin hormone levels cause a rise in the insulin/glucagon ratio during hyperglycemia, which leads to a decrease in fasting and postprandial hepatic glucose production, resulting in lower glycemia.

Metformin Hydrochloride is an antihyperglycemic medication of the biguanide class that is used to treat type 2 diabetes. Both baseline and postprandial plasma glucose levels are reduced. It has a different mode of action than sulfonylureas and does not cause hypoglycemia. By increasing peripheral glucose uptake and utilization, glucomin lowers hepatic glucose synthesis, lowers intestinal glucose absorption, and increases insulin sensitivity.

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). Drug interactions are unlikely with Vildagliptin. Vildagliptin is unlikely to interact with co-medications that are substrates, inhibitors, or inducers of cytochrome P (CYP) 450 enzymes since it is not a CYP 450 enzyme substrate, inhibitor, or inducer.

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 those who have kidney illness or malfunction, a heart attack, or septicaemia. It’s also not recommended for those 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 having radiologic tests that require intravascular injection of iodinated contrast materials, as such products can induce acute renal dysfunction.

Side Effect

Headache, tremor, dizziness, nausea, hypoglycemia, and other side effects are the most prevalent.

Pregnancy & Lactation

Because there are no sufficient and well-controlled trials 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 since it is unknown if Vildagliptin and/or Metformin Hydrochloride are excreted in human milk.

Precautions & Warnings

Metformin buildup can cause lactic acidosis. If metabolic acidosis is detected, therapy should be stopped promptly and the patient admitted to the hospital. Patients with normal renal function should have their serum creatinine levels checked at least once a year, while patients with serum creatinine levels over the upper limit of normal and elderly patients should have their serum creatinine levels checked 2–4 times a year. Patients who develop jaundice or other symptoms of liver impairment should discontinue using Vildagliptin and Metformin tablets if their AST or ALT levels remain at 3 times the upper limit of normal. Treatment with Vildagliptin & Metformin should not be restarted after LFT normalization and removal of Vildagliptin & Metformin. Vildagliptin and Metformin pills should be stopped 48 hours before any elective operation requiring general anaesthetic, and should not be restarted for another 48 hours.

Therapeutic Class

Combination Oral hypoglycemic preparations

Storage Conditions

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

Pharmaceutical Name

General Pharmaceuticals Ltd.