Precautions and warnings

Lactic acidosis can happen if too much Metformin builds up in the body. If doctors think a patient has metabolic acidosis, they should stop the treatment right away and the patient needs to go to the hospital immediately.

Patients with kidney problems:
This medication should not be used in people with kidney failure or kidney issues, such as when blood creatinine levels are higher than 1.5 mg/dL (135 micromol/L) for men or 1.4 mg/dL (110 micromol/L) for women.

Patients with liver problems:
This medication should not be used in people with liver issues, especially if their ALT or AST blood tests are more than three times the normal limit before treatment.

Drug Interactions

Taking this medication with sulfonylureas can increase its effects. Some drugs—such as thiazide diuretics, corticosteroids, phenothiazines, oral contraceptives, sympathomimetics, niacin, calcium channel blockers, and isoniazid—can make it harder to control your blood sugar. ACE inhibitors may help lower your fasting blood sugar. Cimetidine may increase the amount of this medication in your blood.

Warning: Taking this medication with iodinated contrast agents (used in some medical imaging tests) can increase the risk of a serious side effect called lactic acidosis.

Contraindications

This medicine should not be used by patients who are allergic to Vildagliptin, Metformin Hydrochloride, or any of the other ingredients. It is also not suitable for people with kidney disease or kidney problems, those who have had a recent heart attack, or have blood infections (septicemia). People with heart failure, or those with metabolic problems such as diabetic ketoacidosis (with or without coma), should also not take this medicine. If you need to have an X-ray or scan using contrast dye injected into your blood, you should stop taking this medication temporarily, as the dye can affect kidney function.

Mode of actions

**Metformin** is a type of biguanide medicine. It works mainly by lowering the amount of sugar the liver makes, reducing how much sugar the intestines absorb, and helping the body use insulin better by increasing how much sugar is taken up by the muscles. This helps improve how the body handles sugar and lowers blood sugar levels both before and after meals.

**Vildagliptin** is a DPP-4 inhibitor, which means it blocks an enzyme (DPP-4) that normally breaks down hormones called incretins. Incretins help control blood sugar by increasing insulin release and lowering glucagon (a hormone that raises blood sugar) when you eat. By stopping DPP-4, vildagliptin helps incretins work longer, leading to better insulin function, less glucagon, and improved blood sugar control.

Dosage & Administration

Adults: Based on the patient's current dose of Metformin, Combination of Vildagliptin & Metformin may be initiated at either 50 mg/500 mg or 50 mg/850 mg twice daily, 1 tab in the morning and the other in the evening.

The recommended daily dose is 100 mg Vildagliptin plus 2000 mg Metformin HCl. Patients receiving Vildagliptin and Metformin from separate tablets may be switched to Combination of Vildagliptin & Metformin 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 Combination of Vildagliptin & Metformin with or just after food may reduce gastrointestinal symptoms associated with Metformin.

Pregnancy & Lactation

FDA has not yet classified this medicine into a specified pregnancy category. Although there is no enough evidence that taking this medicine during you are pregnant is harmful.

Discuss with your doctor if you are trying to get pregnant while taking this medicine too.

If you do become pregnant while you are taking this medicine, you should continue to take it and contact with your doctors as quickly as possible. They can assist you to decide whether or not to keep taking this medicine. If you abandon taking this medicine and become sick, this would be more pernicious to your child than staying on the medication.


There is no specific information about whether this medicine is passed on to the baby through breast milk. During this medication, if your baby becomes very sleepy, restless, fatigued, exhibit feeding problems, stop breastfeeding and talk to your doctors very quickly.

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