Medication info
Sitagliptin and Metformin Extended-Release Tablets 50/1000 mg

Sitagliptin and Metformin Extended-Release Tablets 50/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
Bright green, oval, biconvex, extended-release film-coated tablets
Packaging
28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202201883 · Approved 2022.05.09 · Insurance code 642906760

Summary

Main use
Improvement in blood sugar control for Type 2 diabetes
Who takes it
Adults
Adult dose
The 100/1000 mg extended-release tablet should be taken once daily, 1 tablet per time. Patients taking the 50/500 mg extended-release tablet or the 50/1000 mg extended-release tablet should take 2 tablets at a time once daily. 1. For patients not currently receiving treatment with metformin: The initial dose is a total daily amount of 100 mg sitagliptin and 1000 mg metformin. If necessary, the dose of metformin may be increased.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Improvement in blood sugar control for Type 2 diabetes

View approved original text

This medication helps control blood sugar levels in patients with Type 2 diabetes by taking sitagliptin and metformin together. When used alongside meal planning and exercise therapy, it aids in effectively improving blood sugar levels. This supports the stable management of diabetes symptoms.

How to take

Adult dose

The 100/1000 mg extended-release tablet should be taken once daily, 1 tablet per time. Patients taking the 50/500 mg extended-release tablet or the 50/1000 mg extended-release tablet should take 2 tablets at a time once daily. 1. For patients not currently receiving treatment with metformin: The initial dose is a total daily amount of 100 mg sitagliptin and 1000 mg metformin. If necessary, the dose of metformin may be increased.

Precautions

This medication contains sitagliptin and metformin and is used for diabetes treatment. First, there may be hypersensitivity reactions upon taking this medication; therefore, if symptoms of allergy, skin rash, or difficulty breathing occur, discontinue use immediately and consult a doctor. Additionally, serious side effects such as acute pancreatitis have been reported, so if abdominal pain, vomiting, or severe abdominal discomfort occurs after taking this medication, notify medical personnel immediately. This medication should not be used in patients with reduced kidney function, and regular assessments of kidney function should be conducted to ensure it is normal. It should especially be avoided in cases of moderate or severe kidney dysfunction, dehydration, severe infections, or heart problems. Patients with acute heart failure or acute myocardial infarction, or those scheduled for examinations using radiographic contrast media containing iodine should also not use this medication. It is advisable not to use this medication in pregnant women or those who may become pregnant, and in nursing mothers, as safety is uncertain. This medication lowers blood sugar; hence, one should be attentive to symptoms of hypoglycemia, as the risk may increase when taking it with other blood sugar-lowering drugs. Patients who exercise heavily or have irregular meal intakes may face a higher risk of hypoglycemia, necessitating careful monitoring. It is recommended to avoid alcohol while taking this medication, as it may increase the risk of serious side effects such as lactic acidosis. Patients with liver dysfunction should avoid this medication and regularly monitor liver and kidney function. Those scheduled for surgery or in a severely ill condition due to infections or trauma should temporarily discontinue use until recovery. Rarely, there may be severe joint pain, skin disorders, or muscle pain as side effects; if such symptoms occur, consult a doctor. Lastly, this medication should not be used in children under 18 years as safety and efficacy have not been sufficiently established. Regular tests of blood sugar, kidney function, and vitamin B12 levels should be conducted while using this medication, and any adverse effects should prompt immediate consultation with medical personnel.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions (including anaphylaxis), severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin reactions (including Stevens-Johnson syndrome), shortness of breath or difficulty breathing, asthma attacks, abnormal respiratory symptoms accompanied by coughing and fever, liver abnormalities (including jaundice symptoms), sudden

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • constipation
  • muscle pain
  • limb pain
Show 8 more
  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • hypoglycemia
  • increased white blood cell count
  • decreased vitamin B12
  • severe joint pain with disability

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is important to keep the storage temperature between 1 and 30 degrees Celsius to maintain the medication's effectiveness safely over time.

Appearance and packaging

Appearance

Bright green, oval, biconvex, extended-release film-coated tablets

Package unit

28 tablets/bottle, 56 tablets/bottle, 200 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.