Medication info

Sitagliptin Metformin Tablets 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›505mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
Bright pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTPX3]
Approval status
Active

MFDS item code 202200908 · Approved 2022.03.02

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally taken twice daily with food, and the dosage should be increased gradually to minimize gastrointestinal side effects caused by metformin. Initial dosage is determined based on the patient’s current therapy. 1. For patients not currently receiving treatment with metformin: Take this medication 50/500 mg twice daily, 1 tablet each time, and it may be increased to 50/1000 mg twice daily, 1 tablet each time.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Difficulty in blood sugar control
View approved original text

This medication assists in controlling blood glucose levels for patients with type 2 diabetes, complementing dietary and exercise regimens. It is used alone for those without prior experience of diabetes medication who find it challenging to control blood sugar. It can also be used in place of monotherapy with metformin or sitagliptin when adequate blood glucose control is not achieved or in the case of dual therapy with both medications. If blood glucose is not controlled, it can be combined with sulfonylureas, thiazolidinediones, or insulin to enhance therapeutic effect. This medication provides assistance to patients struggling to manage blood sugar through various medications.

How to take

Adult dose

This medication is generally taken twice daily with food, and the dosage should be increased gradually to minimize gastrointestinal side effects caused by metformin. Initial dosage is determined based on the patient’s current therapy. 1. For patients not currently receiving treatment with metformin: Take this medication 50/500 mg twice daily, 1 tablet each time, and it may be increased to 50/1000 mg twice daily, 1 tablet each time.

Precautions

This medication is used for diabetes treatment and contains two active ingredients, sitagliptin and metformin. While taking this medication, severe allergic reactions may occur; therefore, if symptoms such as skin rash or respiratory distress appear, discontinue use immediately and consult a physician. Serious side effects have been reported, including acute pancreatitis, which is inflammation of the pancreas, so if symptoms such as abdominal pain or vomiting occur during treatment, notify medical personnel immediately. Patients with severely impaired kidney function, heart failure, or acute myocardial infarction should not use this drug, and it should be discontinued before and after examinations using iodine contrast agents. It is safe for pregnant women or those who might become pregnant, as well as nursing women, not to take this medication. This medication may cause hypoglycemia, so blood glucose levels should be monitored closely, especially when taken with insulin or sulfonylureas. Furthermore, this medication may lead to lactic acidosis, a rare but life-threatening metabolic complication. If sudden symptoms such as respiratory distress, muscle pain, or fatigue occur, notify medical personnel immediately. Regular kidney function and blood tests are recommended during treatment, as vitamin B12 deficiency may occur. Alcohol consumption may increase the risk of side effects from this medication; therefore, excessive drinking should be avoided while on treatment. In cases of undergoing surgery, discontinue use 48 hours prior to the procedure and restart only after confirming normal kidney function. During treatment, regular meals, exercise, and consistent blood glucose testing should be maintained according to the physician's directives.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, exfoliative skin conditions (including Stevens-Johnson syndrome), severe rashes or blisters with high fever, skin peeling, oral/ocular mucosal pain, difficulty breathing, dyspnea, pulmonary dysfunction, jaundice, elevated liver enzymes, acute pancreatitis, severe neurological symptoms (such as intense headache, confusion, seizures, etc.), severe edema, acute renal failure, elevated blood pressure, dyspnea, severe complications

Mild side effects

  • Diarrhea
  • headache
  • upper respiratory infection
  • nasopharyngitis
  • nausea
  • vomiting
  • abdominal pain
  • constipation
  • weakness
  • muscle pain
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  • limb pain
  • back pain
  • pruritus
  • itching
  • dizziness
  • decreased appetite
  • thrombocytopenia
  • severe and disabling arthralgia

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

Storage

Store this medication in a sealed container to prevent the entry of air or moisture, preferably at a temperature between 1 to 30 degrees Celsius. This way, the medication's effectiveness can be well-maintained.

Appearance and packaging

Appearance

Bright pink oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTPX3]

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.