Description
Generic
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 inhibiting 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 in the fasting and postprandial states.
Administration & Dosage
This combination may be started twice daily, with one tablet in the morning and the other in the evening, depending on the patient’s current Metformin dose. Patients who are currently taking Vildagliptin and Metformin as separate tablets may be switched to this combination, which contains the same doses of both drugs. Vildagliptin doses greater than 100 mg are not recommended.
Interaction
When Vildagliptin (100 mg once daily) was combined with Metformin Hydrochloride, no clinically significant pharmacokinetic interaction was observed (1,000 mg once daily). Drug interactions are unlikely with Vildagliptin. Vildagliptin is unlikely to interact with co-medications because it is not a cytochrome P (CYP) 450 enzyme substrate, nor does it inhibit or induce CYP 450 enzymes.
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 disease or dysfunction, a heart attack, or septicaemia.
Side Effect
Headache, tremor, dizziness, nausea, hypoglycemia, and other side effects are the most common.
Pregnancy & Lactation
Because there are no adequate and well-controlled studies in pregnant women, this combination should not be used during pregnancy unless the potential benefit outweighs the risk to the fetus. There have been no studies done on the components of this combination. Because Vildagliptin and/or Metformin Hydrochloride are unknown.
Precautions & Warnings
Metformin accumulation can cause lactic acidosis. If metabolic acidosis is suspected, treatment should be stopped immediately and the patient admitted to the hospital. Patients with normal renal function should have their serum creatinine levels checked at least once a year, and patients with serum creatinine levels above the upper limit of normal and elderly patients should have their serum creatinine levels checked 2–4 times a year.
Therapeutic Class
Oral hypoglycemic preparations in combination
Storage Conditions
Keep away from light and heat in a dry place. Keep out of children’s reach.
