Galvus Tablets (Vildagliptin)

Introduction of Galvus Tablets (Vildagliptin)

Galvus is a medicine that contains the active substance vildagliptin. It is available as a tablet (50 mg).

What is Galvus used for?

• • Galvus is used to treat type-2 diabetes mellitus. It can be used in the following ways:
  
  
• • Its own (monotherapy) in patients whose diabetes is not sufficiently controlled by diet and exercise and who cannot take metformin.
  
  
• • Together with metformin, a thiazolidinedione, or a sulphonylurea (dual therapy) when the patient’s diabetes is insufficiently controlled by this other medicine taken alone, but it is only used in combination with a sulphonylurea in patients who cannot take metformin.
  
  
• •Together with sulphonylurea and metformin (triple therapy) in patients whose diabetes is not sufficiently controlled by these medicines plus diet and exercise.
  
  
• Together with insulin (with or without metformin) in patients whose diabetes is not sufficiently controlled by diet and exercise plus a stable dose of insulin.
  
  
• The medicine can only be obtained with a prescription.

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How is Galvus used?

In adults, the recommended dose of Galvus is:

one tablet in the morning and another in the evening (100 mg per day), when used alone, with metformin, with a thiazolidinedione, with metformin plus a sulphonylurea, or with insulin (with or without metformin).
one tablet in the morning (50 mg per day) when taken with sulphonylurea. A lower dose of sulphonylurea may also be considered to reduce the risk of hypoglycemia (low blood glucose levels).
The daily dose should not exceed two tablets (100 mg). In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily.

How does Galvus work?

Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. The active substance in Galvus, vildagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of ‘incretin’ hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type-2 diabetes.

Precautions of Galvus Tablets (Vildagliptin)

There are several safeguards to be taken while using Vildagliptin tablets: 

Allergies: If you are allergic to vildagliptin or any of the ingredients in Galvus tablets, you should not take them.

Liver disease: Galvus is metabolized in the liver, so if you have liver disease, your doctor may need to adjust your dosage or monitor your liver function more closely.

Pancreatitis: Galvus can cause inflammation of the pancreas (pancreatitis) in rare cases. If you experience severe abdominal pain, nausea, or vomiting, you should seek medical attention immediately.

Heart failure: Galvus should be used with caution in patients with a history of heart failure, as it may worsen the condition.

Pregnancy and breast-feeding: Galvus is not recommended for use during pregnancy or breastfeeding, as the safety of the medication has not been established in these populations.

Hypoglycemia: Galvus can lower blood sugar levels, which can lead to hypoglycemia (low blood sugar). You should monitor your blood sugar levels regularly and talk to your doctor if you experience symptoms of hypoglycemia, such as sweating, shakiness, or confusion.

What benefit has Galvus shown during the studies?

Galvus used on its own was effective at reducing levels of HbA1c, but was less effective than the comparator medicines. In the study comparing Galvus with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Galvus.

When used as an add-on to existing treatment for type-2 diabetes, Galvus was more effective than a placebo in reducing HbA1c levels. With metformin and with pioglitazone, the 100 mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0.8 and 1.0 percentage points. In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6 percentage points. In contrast, patients adding a placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3 to a rise of 0.2 percentage points.

In combination with metformin and glimepiride, 50 mg Galvus taken twice a day reduced HbA1c levels by 1 percentage point, compared with a reduction of 0.3 percentage points in patients taking a placebo.

In the study involving 296 patients taking insulin, adding Galvus caused a greater reduction in HbA1c levels than adding a placebo, but the size of this effect was small possibly due to the fact that the study included long-term patients who were less likely to show improvement. However, in another study involving 449 patients taking insulin, the size of this effect was significant. Patients taking Galvus in addition to insulin, with or without metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared with 0.05 percentage points in patients taking a placebo in addition to insulin.

What is the risk associated with the Galvus tablet?

The most common side effect of Galvus (seen in between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with Galvus, including side effects occurring when Galvus is taken with other antidiabetes medicines, see the package leaflet.

Galvus must not be used in people who are hypersensitive (allergic) to vildagliptin or any of the other ingredients.

Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Galvus and at regular intervals during treatment.

FAQ

Q: What should I do if I miss a dose of Galvus?

A: If you miss a dose of Galvus, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take a double dose to make up for a missed one. If you have overdosed then contact immediately with your physician.

Q: Can Galvus be taken with other diabetes medications?

A: Yes, Galvus can be taken with other diabetes medications, such as metformin or insulin. Your doctor may prescribe a combination of medications to help manage your blood sugar levels.

Interactions of Galvus Tablets (Vildagliptin)

There are many interactions with vildagliptin tablets, so be aware before starting the dose or prescription. Such as Medications that lower blood sugar, Medications that affect liver function, Medications that affect kidney function, Antibiotics, and antifungal medications, and Medications that affect the heart.