Medication info
Sitafol MXR sustained-release tablet 50/500 mg

Sitafol MXR sustained-release tablet 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
Bright blue oval-shaped sustained-release film-coated tablet with a convex surface on both sides
Packaging
28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202202000 · Approved 2022.05.12 · Insurance code 622804860

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is taken once daily with a meal, preferably at dinner, to minimize gastrointestinal side effects from metformin, and the dose should be gradually increased. The 100/1000 mg sustained-release tablet is taken once daily at a single dose of one tablet. Patients taking the 50/500 mg or 50/1000 mg sustained-release tablets should take two tablets simultaneously, once daily. 1. Patients currently not treated with metformin:

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to help control blood sugar levels in patients with type 2 diabetes. It works by combining sitagliptin and metformin to assist with dietary and exercise therapy, effectively improving blood sugar levels.

How to take

Adult dose

This medication is taken once daily with a meal, preferably at dinner, to minimize gastrointestinal side effects from metformin, and the dose should be gradually increased. The 100/1000 mg sustained-release tablet is taken once daily at a single dose of one tablet. Patients taking the 50/500 mg or 50/1000 mg sustained-release tablets should take two tablets simultaneously, once daily. 1. Patients currently not treated with metformin:

Precautions

This medication contains sitagliptin and metformin, and is primarily used for the treatment of type 2 diabetes. Severe allergic reactions may occur during the use of this medication, so if symptoms such as rash, hives, difficulty breathing, swelling of the face or neck occur, discontinue use immediately and consult a physician. Acute pancreatitis, a severe inflammation of the pancreas, can occur, so if symptoms such as abdominal pain, vomiting, or nausea arise, inform medical personnel immediately. Due to the metformin component, rare but fatal metabolic complications such as lactic acidosis may occur; if symptoms such as muscle pain, weakness, difficulty breathing, abdominal pain, or altered consciousness occur, discontinue use immediately and seek medical attention. Patients with moderate to severe renal impairment or with acute conditions that may affect kidney function like severe infection, dehydration, heart failure, acute myocardial infarction, or sepsis should not use this medication. In addition, this medication should be temporarily discontinued before and after examinations using iodine-based contrast agents, and should only be resumed once kidney function is confirmed to be normal. It is safest for women who are pregnant or may become pregnant and for nursing mothers to avoid using this medication. During the use of this medication, there is a heightened risk of hypoglycemia if there are irregular meals, excessive exercise, or if used in conjunction with other diabetic medications. Symptoms of hypoglycemia include dizziness, cold sweats, and severe fatigue; if these symptoms occur, consume sugar immediately or consult medical personnel. Regular kidney function tests, blood tests, and vitamin B12 level checks should be performed, and any unusual symptoms should be reported to medical personnel immediately. Alcohol consumption may increase the risk of lactic acidosis; therefore, it is recommended to avoid alcohol while taking this medication. If surgery is planned, this medication should be discontinued 48 hours prior to the procedure, and should only be resumed after confirming that kidney function is normal post-surgery. Patients taking this medication should fully understand the effects and side effects of the drug, as well as the importance of lifestyle changes, and should consult with medical personnel regarding their treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, Stevens-Johnson syndrome and exfoliative skin diseases, acute pancreatitis, acute renal failure, bullous pemphigoid, elevated liver enzymes, worsening kidney function, severe hypoglycemia, lactic acidosis, symptoms associated with liver dysfunction (jaundice), severe and disabling arthralgia, severe allergic reactions, severe skin reactions, respiratory issues, severe swelling or urination abnormalities, severe kidney problems

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • constipation
  • muscle pain
  • limb pain
Show 6 more
  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • hypoglycemia
  • severe and disabling arthralgia

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, and should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage ensures the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Bright blue oval-shaped sustained-release film-coated tablet with a convex surface on both sides

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.

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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.