Medication info
Esreptin M Tablet 50/1000 mg

Esreptin M Tablet 50/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Pink oval film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202200906 · Approved 2022.03.02 · Insurance code 660703820

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 is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. Patients not treated with metformin: The initial dosage is 1 tablet of 50/500 mg twice daily, and can be increased to 1 tablet of 50/1000 mg twice daily. 2. Patients currently receiving metformin treatment: The initial dosage of sitagliptin is 50 mg.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood sugar control
View approved original text

This drug is used together with dietary and exercise therapies to help control blood sugar levels in patients with type 2 diabetes. It can be used alone for patients who are initiating blood sugar control or as an alternative when metformin or sitagliptin monotherapy is insufficient. Additionally, it can be administered in combination with metformin, sulfonylurea, thiazolidinedione, or insulin to improve blood sugar management when control is difficult. It is effective in enhancing blood sugar control through various therapeutic methods.

How to take

Adult dose

This medication is generally taken twice daily with food, and the dosage is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. Patients not treated with metformin: The initial dosage is 1 tablet of 50/500 mg twice daily, and can be increased to 1 tablet of 50/1000 mg twice daily. 2. Patients currently receiving metformin treatment: The initial dosage of sitagliptin is 50 mg.

Precautions

This drug is an antidiabetic medication containing sitagliptin and metformin components. First, the sitagliptin component may rarely cause serious allergic reactions. These reactions may include anaphylaxis, angioedema, severe rashes or exfoliative skin disorders; if any of these symptoms occur, the medication should be stopped immediately and a doctor should be consulted. Moreover, sitagliptin can cause acute pancreatitis, which is inflammation of the pancreas; if symptoms such as abdominal pain, nausea, or vomiting occur, immediate medical attention should be sought. The metformin component can cause a rare but life-threatening metabolic disorder known as severe lactic acidosis. Symptoms may include muscle pain, weakness, difficulty breathing, and abdominal pain; if these symptoms occur, the medication should be stopped immediately and the patient should go to the hospital. This drug should not be administered to patients with moderate to severe kidney dysfunction, acute heart disease, heart failure, serious infections, dehydration, liver dysfunction, or to pregnant or breastfeeding women. Additionally, if surgery is planned or if undergoing a radiological iodine contrast examination, the use of this medication should be suspended for a certain period, and it should be restarted only after kidney function is confirmed to be normal. Patients taking this drug should have regular kidney function tests, particularly elderly patients or those with slight kidney impairment should be more careful. Irregular meals, malnutrition, excessive exercise, or concomitant use of other glucose-lowering agents or alcohol may increase the risk of hypoglycemia and should be monitored closely. Side effects such as diarrhea, nausea, vomiting, abdominal pain, headache, upper respiratory infection may occur, and hypoglycemic symptoms may also arise. Signs of hypoglycemia include dizziness, shaking, cold sweat, and if any of these symptoms occur, sweet substances should be consumed immediately. Rarely, severe arthralgia, skin rashes, or blistering skin diseases may occur, and if any of these symptoms occur, a doctor should be consulted. The safety of this drug during pregnancy and breastfeeding has not been established, and it is not recommended for use in children under 18, as safety and efficacy have not been confirmed. In the case of overdose, immediate medical attention should be sought for appropriate treatment, and blood dialysis may be necessary to remove the drug. Finally, the risk of lactic acidosis increases when this drug is taken with alcohol, so avoiding alcoholic beverages is important. During treatment with this drug, regular blood glucose tests and kidney function tests should be performed, and if any abnormal symptoms occur, prompt notification to healthcare personnel is essential.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), rash, chest tightness, difficulty breathing (dyspnea), cold sweat, pallor, severe rash with high fever, blisters, exfoliative skin disorders, pain in mucous membranes of mouth/eyes, acute pancreatitis, acute renal failure, increased liver enzyme levels, liver dysfunction (including jaundice), severe edema, sudden and very severe headaches, thunderclap headache, consciousness confusion, visual disturbances, paralysis, severe joint pain accompanied by disability

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

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

Storage

This drug should be stored in a tightly sealed container to prevent air or moisture from entering, and it should be kept at room temperature between 1 degree and 30 degrees. Proper storage preserves the effectiveness of the medication and prevents degradation.

Appearance and packaging

Appearance

Pink oval film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP x 3]

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.