Generic: Vildagliptin Metformin Hydrochloride  |  Dosage Form: Tablet  |  Manufacturer: Biogen Pharmaceuticals Ltd.

Indications

This tablet is indicated as an adjunct to diet and exercises to improve glycaemic control in patients with type 2 diabetes mellitus whose diabetes is 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.

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. As a result of these studies no clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin hydrochloride), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin. On the other hand, furosemide, nifedipine and glyburide increase Cmax and blood AUC of Metformin with no change in renal clearance of Metformin.

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.

Precautions & Warnings

Lactic acidosis can occur due to Metformin accumulation. If metabolic acidosis is suspected, treatment should be discontinued and the patient should be hospitalized immediately. Serum creatinine should be monitored at least once a year in patients with normal renal function and 2–4 times a year in patients with serum creatinine levels at the upper limit of normal and in elderly patients. Special caution should be exercised in elderly patients where renal function may become impaired (e.g. when initiating antihypertensives, diuretics or NSAIDs). It is recommended that Liver Function Tests (LFTs) are monitored prior to initiation of this drug, at three-monthly intervals in the first year and periodically thereafter. If transaminase levels are increased, patients should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality return to normal. If AST or ALT persist at 3 x ULN, Vildagliptin & Metformin tablets should be stopped Patients who develop jaundice or other signs of liver dysfunction. Following withdrawal of treatment with Vildagliptin & Metformin and LFT normalization, treatment with Vildagliptin & Metformin should not be reinitiated. Vildagliptin & Metformin tablets should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.

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.