Medication info

Sitavis M Tablet 50/500 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Phosphate Hydrate›64.25mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
Pink oval film-coated tablet
Packaging
28 tablets (14 tablets/PTP×2), 56 tablets (14 tablets/PTP×4)
Approval status
Expired

MFDS item code 201505755 · Approved 2015.08.18

This product's status changed to Expired on 2025.08.18. 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 dosage of this medication is determined considering the patient's current treatment regimen, efficacy, and tolerability, without exceeding Sitagliptin 100 mg and Metformin 2000 mg. Generally, it is taken twice daily with food, and the dosage is gradually increased to reduce gastrointestinal side effects caused by Metformin. 1. For patients not previously treated with Metformin: This medication 50/500 mg should be taken twice a day, one tablet each time.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to assist patients with type 2 diabetes in controlling blood sugar when combined with diet and exercise. Sitagliptin and Metformin work together to effectively lower and manage blood sugar levels. Therefore, this medication is used as an adjunct therapy to improve your blood sugar control.

How to take

Adult dose

The dosage of this medication is determined considering the patient's current treatment regimen, efficacy, and tolerability, without exceeding Sitagliptin 100 mg and Metformin 2000 mg. Generally, it is taken twice daily with food, and the dosage is gradually increased to reduce gastrointestinal side effects caused by Metformin. 1. For patients not previously treated with Metformin: This medication 50/500 mg should be taken twice a day, one tablet each time.

Precautions

This medication helps to control blood sugar levels. However, there are several precautions to consider when taking this medication. Firstly, an allergic reaction may occur; if symptoms such as rash or difficulty breathing appear, discontinue use immediately and consult a physician. Additionally, acute pancreatitis, a serious pancreatic disorder, may occur rarely, so if you experience symptoms such as abdominal pain, nausea, or vomiting, go to the hospital immediately. One component of this medication, Metformin, can be dangerous for patients with decreased kidney function, and may cause lactic acidosis, a serious metabolic disorder, so kidney function tests should be performed regularly. In particular, patients with moderate to severe renal impairment, those with severe infections or dehydration, patients with heart failure, and pregnant or nursing women should not take this medication. During treatment, hypoglycemia may occur, so care should be taken during missed meals or vigorous exercise, and the risk of hypoglycemia may increase when taken with other blood sugar lowering agents. Moreover, this medication requires caution in patients with liver dysfunction, and alcohol intake may increase the risk of lactic acidosis, so it should be avoided. If undergoing surgery or undergoing iodinated contrast tests, this medication should be temporarily discontinued and restarted only after kidney function has recovered. Routine checks of blood sugar, renal function, liver function, and vitamin B12 levels should be done during treatment, and any abnormal symptoms should be reported to healthcare providers immediately. Lastly, this medication is not recommended for children under 18 years of age as safety and efficacy have not been established.

Side effects and when to seek care immediately

Serious side effects

  • Severe hypersensitivity reactions such as hives, angioedema, anaphylaxis, and Stevens-Johnson Syndrome
  • Acute pancreatitis (including fatal/non-fatal hemorrhagic or necrotizing pancreatitis)
  • Acute renal failure (sometimes requiring dialysis), worsening of renal function
  • Breathing difficulties
  • Hypoglycemia (including severe)
  • Lactic acidosis
  • Severe joint pain with disability
  • Bullous pemphigoid
  • Acute renal failure
  • Breathing difficulties
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  • Unstable angina
  • Acute and chronic liver dysfunction (increased liver enzyme levels, potential jaundice)

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • constipation
  • muscle pain
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • dermatitis
  • loss of appetite
  • weight loss
  • decreased appetite
  • dizziness

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

Storage

This medication should be stored in a sealed container that does not allow air in, preferably at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication and prevents degradation.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

28 tablets (14 tablets/PTP×2), 56 tablets (14 tablets/PTP×4)

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.