SB-Metvilda 50/850

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 activity 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 boosting endogenous levels of these incretin hormones.

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

No clinically relevant pharmacokinetic interaction was observed when Vildagliptin (100 mg once daily) was co-administered with Metformin Hydrochloride (1,000 mg once daily). Vildagliptin has a low potential for drug interactions. Since Vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate nor does it inhibit nor induces CYP 450 enzymes, it is not likely to interact with co-medications that are substrates, inhibitors or inducers of these enzymes.

Contraindications

This combination is contraindicated in patients with known hypersensitivity to Vildagliptin or Metformin Hydrochloride or to any of the excipients. It is contraindicated in patients with renal disease or renal dysfunction, acute myocardial infarction, and septicaemia. It is also contraindicated in patients with congestive heart failure patients and in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. It should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

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

Metformin buildup can cause lactic acidosis. If metabolic acidosis is suspected, medication 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 creatinine levels checked 2–4 times a year.

Therapeutic Class

Combination Oral hypoglycemic preparations

Storage Conditions

Keep the temperature below 30°C and away from light and moisture. Keep out of children's reach.

Pharmaceutical Name

Sunman-Birdem Pharma Ltd.