Medication info
Sitagliptin Metformin Extended Release Tablet 50/1000 mg

Sitagliptin Metformin Extended Release Tablet 50/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Bright green oval extended-release film-coated tablets
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300578 · Approved 2023.02.16 · Insurance code 645605840

Summary

Main use
Improvement in blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
For the 100/1000 mg extended-release tablet, take one tablet once daily. Patients taking the 50/500 mg extended-release tablet or the 50/1000 mg extended-release tablet should take two tablets at once once daily. 1. For patients not currently treated with metformin: The initial total daily amount is 100 mg of sitagliptin and 1000 mg of metformin. If necessary, the metformin dose may be gradually increased.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Improvement in blood glucose control in type 2 diabetes

View approved original text

This medication helps improve blood glucose control in patients with type 2 diabetes when used in conjunction with diet and exercise. The combination of sitagliptin and metformin effectively lowers blood glucose levels, making it useful for diabetes management. It can improve blood glucose control and reduce the risk of complications.

How to take

Adult dose

For the 100/1000 mg extended-release tablet, take one tablet once daily. Patients taking the 50/500 mg extended-release tablet or the 50/1000 mg extended-release tablet should take two tablets at once once daily. 1. For patients not currently treated with metformin: The initial total daily amount is 100 mg of sitagliptin and 1000 mg of metformin. If necessary, the metformin dose may be gradually increased.

Precautions

This medication contains two ingredients: sitagliptin and metformin. Firstly, the sitagliptin component can cause rare but serious allergic reactions. These reactions can include hives, angioedema, anaphylaxis, or severe skin conditions with skin peeling. If any abnormal symptoms appear within three months after taking the medication, the drug should be immediately discontinued and a doctor should be consulted. Additionally, sitagliptin carries a risk of acute pancreatitis, which involves inflammation of the pancreas. If symptoms of pancreatitis such as abdominal pain or vomiting occur during treatment, the medication must be stopped immediately and medical personnel should be informed. Secondly, the metformin component can cause a rare side effect called lactic acidosis, which is a dangerous condition characterized by abnormal accumulation of lactic acid in the blood, with symptoms including muscle pain, breathing difficulties, and fatigue. Immediate treatment is necessary if these symptoms occur. This medication should not be administered to patients with moderate to severe renal impairment, acute heart failure, severe infections, dehydration, acute myocardial infarction, patients scheduled for radiographic contrast examinations, type 1 diabetes patients, or women who are pregnant or breastfeeding. Particularly, if a patient is to undergo a contrast procedure, this medication should be paused for a certain period before and after the examination to reduce kidney burden, and it should only be resumed after confirming normal kidney function. Furthermore, patients with irregular eating habits, excessive exercise, those taking certain medications, and those allergic to the ingredient Yellow No. 4 (tartrazine) should be cautious when using this medication. During treatment, abnormal symptoms such as gastrointestinal disturbances, hypoglycemia, and allergic reactions may occur, thus careful observation is necessary, and immediate consultation with medical personnel is required if any abnormal symptoms appear.

Side effects and when to seek care immediately

Serious side effects

  • Severe hypersensitivity reactions (anaphylaxis, angioedema, Stevens-Johnson syndrome, etc.)
  • Acute pancreatitis
  • Lactic acidosis and hypoglycemia

Mild side effects

Gastrointestinal disturbances

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is important to maintain a temperature between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Bright green oval extended-release film-coated tablets

Package unit

Bottle - 100 tablets/bottle, Bottle - 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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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.