Medication info

Esbya Tablet 25 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.35mg / 1 tablet
Manufacturer / importer
(주)보령바이오파마
Appearance
Pink, round, biconvex, film-coated tablet
Packaging
PTP) 28 tablets/box (14 tablets/PTP×2), 30 tablets/box (10 tablets/PTP×3)
Approval status
Expired

MFDS item code 202005817 · Approved 2020.08.14

This product's status changed to Expired on 2025.08.14. 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 takes it
Adults
Adult dose
This medication is administered as 100 mg once daily for either monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken without regard to meals. In patients with renal impairment, dose adjustments are required based on renal function. - Mild renal impairment (eGFR 60–90 mL/min/1.73 m2): No dose adjustment needed - Moderate renal impairment (eGFR 45–60 mL/min/1.73 m2): Dose adjustment needed

Ingredients

Manufacturer
(주)보령바이오파마

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 as an adjunct to diet and exercise to improve blood glucose control in patients with type 2 diabetes. It can also be used as monotherapy and may be prescribed to patients initiating pharmacotherapy. If blood glucose control is inadequate with monotherapy, it can be used in combination with other diabetes medications such as metformin, sulfonylureas, or insulin. The drug can be added to therapy if blood glucose control is insufficient despite the use of multiple medications, enhancing treatment efficacy. Thus, this medication is effectively utilized for glucose control tailored to various therapeutic situations in diabetes management.

How to take

Adult dose

This medication is administered as 100 mg once daily for either monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken without regard to meals. In patients with renal impairment, dose adjustments are required based on renal function. - Mild renal impairment (eGFR 60–90 mL/min/1.73 m2): No dose adjustment needed - Moderate renal impairment (eGFR 45–60 mL/min/1.73 m2): Dose adjustment needed

Precautions

This medication may cause severe allergic reactions during use, so if symptoms such as skin rash or difficulty breathing occur, discontinue use immediately and seek medical attention. This medication can lead to severe pancreatic inflammation known as acute pancreatitis; therefore, patients must seek prompt medical consultation if symptoms like abdominal pain, nausea, or vomiting arise after taking the drug. This medication should not be administered to patients with type 1 diabetes or diabetic ketoacidosis, and it should be avoided in individuals with known hypersensitivity to this drug or its components. Patients with impaired renal function need dosage adjustment, and regular renal function tests are essential. The risk of hypoglycemia may increase when this medication is used with other antidiabetic agents, so patients should be alert to symptoms of hypoglycemia and adjust the doses of other medications if necessary. Severe joint pain may occur, so if significant arthralgia develops, the use of this medication should be discontinued and the patient should consult a doctor. If blistering or skin ulceration occurs, it should be reported to a physician immediately, and dermatological evaluation may be necessary. This medication is not recommended for use during pregnancy, and breastfeeding women should also avoid taking it. Safety and efficacy in children and adolescents have not been established, so it is not to be used in individuals under 18 years of age. Elderly patients are at a higher risk of decreased renal function, so renal function should be assessed before administration, and regular monitoring during treatment is advised. In case of overdose, general emergency measures should be taken, and if necessary, some drugs may be removed via dialysis. This medication does not have major interactions with other drugs, but caution is needed when used concurrently with digoxin or cyclosporine. Report any adverse reactions or side effects promptly to a healthcare professional, and regular examinations should be performed to ensure safe use.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, skin rash, exfoliative skin disease (including Stevens-Johnson syndrome), pancreatitis, acute pancreatitis, difficulty breathing, liver abnormalities (including increased liver enzyme levels, though jaundice is not specifically noted), severe and disabling arthralgia, bullous pemphigoid, acute renal failure, severe hypoglycemia, cardiac arrest

Mild side effects

  • Upper respiratory tract infection
  • nasopharyngitis
  • headache
  • diarrhea
  • dyspepsia
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
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  • interstitial lung disease
  • pruritus
  • thrombocytopenia
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

Store this medication in a tightly closed container to prevent air intrusion, at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the drug's effectiveness and safety for use.

Appearance and packaging

Appearance

Pink, round, biconvex, film-coated tablet

Package unit

PTP) 28 tablets/box (14 tablets/PTP×2), 30 tablets/box (10 tablets/PTP×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.