Medication info

Sitaglomet Metformin Tablets 50/1000 mg

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 201507993 · 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This product's status changed to Approval withdrawn on 2023.05.18.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 sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is generally taken twice daily with food, and the dose is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients who are not currently treated with metformin: Start with this drug at 50/500 mg, taking one tablet twice daily, and may increase to 50/1000 mg. 2. For patients currently receiving metformin: Start the dosage with sitagliptin at 50 mg twice daily.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Type 2 diabetes
  • abnormal blood sugar control
View approved original text

This medication is used in conjunction with dietary and exercise therapy to help improve blood sugar control in patients with type 2 diabetes. Initially, it can be administered alone to patients who have no previous experience with diabetes medication. It may also be used if blood sugar control is inadequate with monotherapy using metformin or sitagliptin. Additionally, it can be used in combination with metformin and sulfonylurea, or metformin and thiazolidinedione therapy when adequate blood sugar control is not achieved. This drug can also be used effectively with insulin and metformin if control is still inadequate, providing various options for improving blood sugar control.

Dosage and Administration

Adult dosage

This medication is generally taken twice daily with food, and the dose is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients who are not currently treated with metformin: Start with this drug at 50/500 mg, taking one tablet twice daily, and may increase to 50/1000 mg. 2. For patients currently receiving metformin: Start the dosage with sitagliptin at 50 mg twice daily.

Precautions

This medication is composed of two ingredients: sitagliptin and metformin, and is used for blood sugar control in patients with type 2 diabetes. Firstly, during the use of this medication, severe allergic reactions such as skin rash, swelling, or difficulty breathing may occur. If such symptoms arise, stop taking the medication immediately and consult a doctor. Also, acute pancreatitis, a serious inflammation of the pancreas, may occur, so if symptoms such as abdominal pain, vomiting, or fever appear, inform a healthcare professional immediately. The metformin in this drug can cause lactic acidosis, a rare but potentially fatal metabolic condition. Therefore, patients with impaired kidney function, liver dysfunction, severe infections, or dehydration should not take this medication. Specifically, if kidney function is moderately impaired or if there are acute conditions such as heart failure, acute myocardial infarction, or sepsis, this drug should not be used. Administration should also be suspended before and after examinations using iodinated contrast agents. This medication has not been confirmed safe for use in pregnant or breastfeeding women, nor in children and adolescents under 18 years of age. While taking this medication, regular kidney function tests should be conducted to monitor kidney status, and alcohol consumption should be avoided as it may increase the risk of lactic acidosis. The risk of hypoglycemia may increase when taken with other blood sugar-lowering medications, so patients should be cautious of hypoglycemic symptoms and may need adjustments in dosages of those medications as necessary. Additionally, irregular meals, vigorous exercise, and nutritional imbalances can increase the risk of hypoglycemia or lactic acidosis, so caution is advised. Severe joint pain, skin conditions, and liver dysfunction have been reported as side effects, so if any abnormal symptoms occur, inform a healthcare professional immediately. After surgery, the use of this medication should be suspended for a certain period, and it is important for patients and their families to receive adequate education regarding the medication's side effects and precautions.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), tightness in the chest, difficulty breathing, anaphylaxis, Stevens-Johnson syndrome (severe skin reactions), acute pancreatitis, acute renal failure, severe joint pain, blistering similar to pemphigus, thrombocytopenia, acute renal failure, dyspnea, unstable angina, severe hypoglycemia, severe allergic reactions, severe swelling or urinary abnormalities

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
  • decreased appetite
  • itching
  • dizziness
  • hypoglycemia
  • dermatitis
  • weight loss

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 kept at room temperature between 1 to 30 degrees Celsius. Proper storage can help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

Red 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.