Medication info

Vildagliptin Tablets 100 mg (Sitagliptin Phosphate Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
Beige, round, bilaterally convex film-coated tablet
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 201503236 · Approved 2015.05.28

This product's status changed to Expired on 2025.05.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The drug is administered once daily at a dose of 100 mg in monotherapy or in combination therapy, with a maximum daily dose of 100 mg. This drug can be taken regardless of meals. For patients with renal impairment, dosage adjustment is required based on kidney function. - Mild renal impairment (eGFR 60–90 mL/min/1.73 m2): no dosage adjustment needed. - Moderate renal impairment (eGFR 45–60 mL/min/1.73

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Blood sugar control in type 2 diabetes patients
View approved original text

This medication is an adjunct to diet and exercise in improving glycemic control in patients with type 2 diabetes. It may be used alone at the initiation of therapy in patients with type 2 diabetes, and if glycemic control is inadequate on monotherapy, it may be used in combination with metformin. Additionally, this drug may be added to patients with type 2 diabetes who are not adequately controlled on monotherapy or various combination therapies such as sulfonylureas, metformin, thiazolidinediones, or insulin, to improve glycemic control. Therefore, this medication can effectively manage blood sugar levels that are not controlled by various other treatment options.

How to take

Adult dose

The drug is administered once daily at a dose of 100 mg in monotherapy or in combination therapy, with a maximum daily dose of 100 mg. This drug can be taken regardless of meals. For patients with renal impairment, dosage adjustment is required based on kidney function. - Mild renal impairment (eGFR 60–90 mL/min/1.73 m2): no dosage adjustment needed. - Moderate renal impairment (eGFR 45–60 mL/min/1.73

Precautions

This medication can cause serious allergic reactions in some patients. If symptoms such as skin rash or difficulty breathing occur within 3 months of administration, discontinue immediately and consult a doctor. During the use of this medication, serious pancreatic inflammation, known as pancreatitis, may occur, so immediate notification to healthcare professionals is necessary in cases of severe abdominal pain or vomiting. This medication should not be used in patients with type 1 diabetes or those with diabetic ketoacidosis, and patients with known allergies to this drug or any of its components should also avoid its use. Patients with impaired renal function should adjust the dosage of this medication, so regular kidney function tests should be conducted and it should be taken according to the doctor's instructions. During treatment, symptoms similar to a cold or headaches may occur, and some patients may experience hypoglycemic symptoms; therefore, it is important to monitor blood sugar levels periodically. When taken with other hypoglycemic agents like insulin or sulfonylureas, the risk of hypoglycemia may increase, so dosage adjustments may be required. This medication is not recommended for use in pregnant or breastfeeding women, nor has its safety and efficacy been established in children or adolescents under 18 years of age. Older adults may have reduced renal function, so renal function should be assessed prior to use, and regular assessments should continue during treatment. In case of overdose, symptomatic treatment will be provided, and if necessary, some medications may be removed via hemodialysis. If blisters appear on the skin or severe joint pain occurs during use, report immediately to a physician and discontinue treatment. Generally, interactions with other medications are minimal, but the blood concentration may vary slightly when taking certain medications, so inform a doctor or pharmacist before use. In general, this medication does not increase cardiovascular risk, but if there is a history of cardiovascular disease, regular check-ups are necessary.

Side effects and when to seek care immediately

Serious side effects

Severe allergic reactions (including rash and angioedema), anaphylaxis, exfoliative skin diseases such as Stevens-Johnson syndrome, acute pancreatitis, severe allergic reactions (including rash, severe swelling, tightness in the chest, difficulty breathing, cold sweat, paleness), severe skin reactions (severe rash, blistering, skin peeling, pain in mucous membranes of the mouth/eyes), respiratory problems (including shortness of breath or difficulty breathing, asthma attacks, coughing)

Mild side effects

  • Upper respiratory tract infection
  • nasopharyngitis
  • headache
  • constipation
  • vomiting
  • muscle pain
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • diarrhea
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoproteins
  • hyperglycemia
  • weight loss
  • hypernatremia
  • erectile dysfunction

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent entry of air, ideally at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the efficacy of the medication and prevent degradation.

Appearance and packaging

Appearance

Beige, round, bilaterally convex film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.