Medication info
Sitamet XR Sustained-release Tablet 50/500 mg (Sitagliptin, Metformin)

Sitamet XR Sustained-release Tablet 50/500 mg (Sitagliptin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tabletSitagliptin Phosphate Hydrate›64.25mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Bright blue, double-convex, oval-shaped, sustained-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201505031 · Approved 2015.07.23 · Insurance code 643507370

Summary

Main use
Improvement in blood glucose control for type 2 diabetes
Who takes it
Adults
Adult dose
In diabetes therapy, the dosage of this medication is determined within the limits of the maximum recommended daily doses of each ingredient: sitagliptin 100 mg and metformin 2000 mg, considering each patient's current treatment regimen, effectiveness, and tolerability. This medication is intended to be taken once daily, at dinner, with meals to reduce gastrointestinal adverse reactions caused by metformin, and the dosage is gradually increased.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Improvement in blood glucose control for type 2 diabetes

View approved original text

This medication helps improve blood glucose control in patients with type 2 diabetes by combining sitagliptin and metformin. When administered alongside dietary control and exercise therapy, it is effective in managing blood glucose levels, thereby contributing to more stable blood glucose maintenance. Therefore, this medication is used for the treatment of type 2 diabetes.

How to take

Adult dose

In diabetes therapy, the dosage of this medication is determined within the limits of the maximum recommended daily doses of each ingredient: sitagliptin 100 mg and metformin 2000 mg, considering each patient's current treatment regimen, effectiveness, and tolerability. This medication is intended to be taken once daily, at dinner, with meals to reduce gastrointestinal adverse reactions caused by metformin, and the dosage is gradually increased.

Precautions

This medication contains sitagliptin and metformin and is primarily used for the treatment of type 2 diabetes. During the use of this medication, serious allergic reactions may occur, so if you experience a skin rash, difficulty breathing, or swelling of the face or neck, you should immediately discontinue use and consult a physician. Pancreatitis, an inflammation of the pancreas, may occur rarely, so if you experience symptoms such as abdominal pain, nausea, or vomiting, you must inform medical personnel immediately. Patients with poor kidney function, especially those with moderate to severe renal impairment, should not take this medication, and caution is needed in conditions that may cause a rapid deterioration in kidney function. Patients with severe heart failure, acute myocardial infarction, severe infections, or other unstable physical conditions should also avoid taking this medication. Prior to and after the use of iodine-containing contrast agents for testing, the use of this medication should be temporarily discontinued, and it should be resumed only after confirming normal kidney function. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. Irregular eating, excessive exercise, or concurrent use with other medications may increase the risk of side effects such as hypoglycemia or lactic acidosis, so caution is necessary. Gastrointestinal side effects such as diarrhea, nausea, vomiting, and abdominal pain may occur with this medication, and if these symptoms persist or worsen, you should consult with medical personnel. Symptoms of hypoglycemia may appear, so especially when taken together with insulin or sulfonylurea drugs, blood glucose levels should be monitored frequently, and appropriate actions should be taken in the event of hypoglycemic symptoms. During treatment with this medication, regular kidney function and hematological tests should be conducted, as vitamin B12 deficiency may occur and periodic testing is required. Patients awaiting surgery should discontinue this medication 48 hours prior to surgery and can resume once kidney function has recovered to normal post-surgery. Excessive alcohol intake increases the risk of lactic acidosis, so alcohol consumption should be avoided during treatment. If symptoms such as sudden difficulty breathing, muscle pain, weakness, or alterations in consciousness occur during the use of this medication, you must inform medical personnel immediately. Elderly patients may have a potential decline in kidney function, making dosage adjustment and regular kidney function monitoring important. In case of overdose, consult medical personnel immediately, and treatment such as hemodialysis may be required if necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, rash, exfoliative skin disease, Stevens-Johnson syndrome, acute pancreatitis, acute renal failure, severe hypoglycemia (including loss of consciousness or seizures), bullous pemphigoid, acute pancreatitis, severe neurological symptoms (headache, seizures, confusion, visual disturbances, paralysis), jaundice, severe edema, urinary abnormalities, lactic acidosis, liver dysfunction, severe allergic reactions

Mild side effects

  • Diarrhea
  • upper respiratory tract infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • constipation
  • muscle pain
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • hypoglycemia
  • severe and disabling arthralgia
  • bullous pemphigoid

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature. This helps maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Bright blue, double-convex, oval-shaped, sustained-release 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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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.