Medication info

Sitaglmet Tablets 50/500 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Sitagliptin Phosphate›Strength being verifiedMetformin Hydrochloride›Strength being verified
Manufacturer / importer
알리코제약(주)
Appearance
Bright pink oval film-coated tablet
Packaging
28 tablets (14 tablets/PTP×2)
Approval status
Approval withdrawn

MFDS item code 201507991 · Approved 2015.11.27

This product's status changed to Approval withdrawn on 2023.05.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is usually taken twice a day with food, and the dosage should be gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients who are not currently treated with metformin: Take this drug 50/500 mg, 1 tablet twice a day, and may increase to 50/1000 mg, 1 tablet twice a day. 2. For patients already treated with metformin:

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

  • Difficulty in blood glucose control in patients with type 2 diabetes
View approved original text

This medication is used in conjunction with diet and exercise to help improve blood glucose control in patients with type 2 diabetes. It is effective for patients who have not previously used other diabetes medications or who have difficulty controlling blood glucose with monotherapy. This drug may be used in combination when metformin or sitagliptin monotherapy is not sufficient. Additionally, this drug is used when blood glucose control is difficult with combinations of metformin and sulfonylureas, or metformin and thiazolidinediones. It is also added to control blood glucose when the combination of insulin and metformin is ineffective. Therefore, this medication is used to improve blood glucose control in patients with type 2 diabetes at various stages of treatment.

Dosage and Administration

Adult dosage

This medication is usually taken twice a day with food, and the dosage should be gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients who are not currently treated with metformin: Take this drug 50/500 mg, 1 tablet twice a day, and may increase to 50/1000 mg, 1 tablet twice a day. 2. For patients already treated with metformin:

Precautions

This medication is used for diabetes treatment, and its two components work together to lower blood glucose levels. During the use of this medication, serious allergic reactions may occur; therefore, if symptoms such as skin rash or difficulty breathing appear, the medication should be discontinued immediately, and a healthcare professional should be consulted. Additionally, acute pancreatitis, a serious inflammation of the pancreas, may rarely occur; if symptoms such as abdominal pain, vomiting, or loss of appetite appear, the doctor should be notified immediately. This drug should not be administered to patients with severely impaired renal function or those with severe infections or dehydration, and should also be discontinued before and after surgeries or tests using contrast agents. It is not recommended for use in pregnant or lactating women or in children under 18 years of age as safety has not been established. This medication carries a risk of hypoglycemia; therefore, careful monitoring of blood glucose changes is essential, especially when taken together with insulin or sulfonylureas. During treatment, it is important to maintain a regular eating schedule and appropriate exercise, as well as to undergo regular kidney function and blood tests. Alcohol consumption should be avoided as it may increase the risk of lactic acidosis, which is a side effect of this drug. If an overdose is suspected, seek medical attention immediately for appropriate treatment, which may include blood dialysis. If discomfort or adverse effects occur while taking this medication, consult with a doctor or pharmacist immediately for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, Stevens-Johnson syndrome and exfoliative skin diseases, acute pancreatitis, acute renal failure, dyspnea, acute lactic acidosis, severe hypoglycemia, acute renal failure, jaundice, severe joint pain with disability, bullous pemphigoid.

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • constipation
  • myalgia
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • reduced appetite
  • itching
  • dizziness
  • hypoglycemia
  • severe joint pain with disability
  • bullous pemphigoid.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright pink oval film-coated tablet

Package unit

28 tablets (14 tablets/PTP×2)

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.