Medication info
Sitafomin XR Extended-Release Tablet 50/500 mg

Sitafomin XR Extended-Release Tablet 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
A bright blue, oval-shaped, bilayered extended-release film-coated tablet.
Packaging
28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202202026 · Approved 2022.05.13 · Insurance code 669908290

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The dosage of this medication is determined based on each ingredient's maximum recommended daily dose, which should not exceed 100 mg of sitagliptin and 2000 mg of metformin, taking into account each patient's current treatment regimen, effectiveness, and tolerability. This medication should be taken once daily with dinner to minimize gastrointestinal side effects from metformin, and dosage should be gradually increased. Extended-release tablets should not be split, crushed, dissolved, or chewed.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication helps control blood sugar levels in patients with type 2 diabetes by combining sitagliptin and metformin. It is particularly effective for those managing their diet and engaging in exercise therapy, assisting in maintaining more stable blood sugar levels. This enables more effective management of diabetes and supports a healthy lifestyle.

How to take

Adult dose

The dosage of this medication is determined based on each ingredient's maximum recommended daily dose, which should not exceed 100 mg of sitagliptin and 2000 mg of metformin, taking into account each patient's current treatment regimen, effectiveness, and tolerability. This medication should be taken once daily with dinner to minimize gastrointestinal side effects from metformin, and dosage should be gradually increased. Extended-release tablets should not be split, crushed, dissolved, or chewed.

Precautions

This medication contains two components, sitagliptin and metformin, used in diabetes treatment. First, sitagliptin may rarely cause severe allergic reactions, so if symptoms such as rash, difficulty breathing, or swelling of the face or neck occur after taking this medication, discontinue use immediately and consult a physician. Additionally, sitagliptin may cause pancreatitis, which is inflammation of the pancreas, so it is important to inform medical personnel immediately if abdominal pain, nausea, or vomiting occur during treatment. Metformin can rarely cause lactic acidosis, a serious metabolic anomaly, which might present with symptoms such as muscle pain, difficulty breathing, fatigue, and abdominal pain. If these symptoms arise, discontinue use immediately and visit a hospital. This medication should not be given to patients with impaired kidney function, severe infections or dehydration, acute heart failure or myocardial infarction, or those with compromised liver function. Moreover, this medication should be temporarily discontinued before and after tests using iodine contrast agents to reduce the risk of kidney damage and lactic acidosis, and it should be resumed only after confirming normal kidney function post-examination. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. During the use of this medication, it is important to maintain a regular meal schedule and exercise for blood sugar control. If symptoms of hypoglycemia (dizziness, cold sweat, severe hunger, etc.) occur, immediate action should be taken. Furthermore, alcohol consumption may increase the risk of lactic acidosis, so it is advisable to avoid drinking during the treatment period. Regular kidney function and blood tests should be conducted, particularly for elderly patients or those with slight reductions in kidney function who require closer monitoring. Finally, it is important to report any new symptoms or adverse reactions that occur during treatment to the medical staff immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, exfoliative skin disease (Stevens-Johnson syndrome), acute pancreatitis, acute renal failure, severe and disabling joint pain, bullous pemphigoid, elevated liver enzymes, liver abnormalities (related to jaundice), severe lactic acidosis, severe hypoglycemia, severe swelling accompanied by increased blood pressure, deterioration of kidney function, serious allergic reactions

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory infection
  • nasopharyngitis
  • headache
  • hypoglycemia
  • muscle pain
  • limb pain
Show 4 more
  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis

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

Storage

This medication may be sensitive to air or moisture, so it is important to store it in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius (room temperature), avoiding extremely hot or cold places.

Appearance and packaging

Appearance

A bright blue, oval-shaped, bilayered extended-release film-coated tablet.

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.